i
The table of contents on the first page contains quick links to the referenced page numbers in this Chapter. Refer to the notes at the end of
a Section to learn about the history of a rule as it was published in the Arizona Administrative Register.
Please note that the Chapter you are about to replace may have rules still in effect after the publication date of this supplement. Therefore,
all superseded material should be retained in a separate binder and archived for future reference.
Sections, Parts, Exhibits, Tables or Appendices codified in this supplement. The list provided contains quick links to the updated rules.
The release of this Chapter in Supp. 20-1 replaces Supp.
This Chapter contains rule Sections that were filed to be codified in the Arizona Administrative Code between the dates of
January 1, 2020 through March 31, 2020.
R4-23-110.
Definitions ............................................................4
R4-23-204. Continuing Education Requirements ................. 17
R4-23-205. Fees ....................................................................18
R4-23-407. Prescription Requirements ................................. 24
R4-23-408. Computer Records ............................................. 27
R4-23-411. Pharmacist-administered or Intern-administered
Immunizations ....................................................31
R4-23-607. Nonresident Permits ...........................................46
R4-23-801. Repealed .............................................................74
R4-23-1103. Pharmacy Technician Trainee Licensure ............77
R4-23-1106. Continuing Education Requirements .................80
Supp. 20-1
Questions about these rules? Contact:
Department: Board of Pharmacy
Name: Kamlesh Gandhi
Address: 1616 W. Adams St., Suite 120
Phoenix, AZ 85007
Telephone: (602) 771-2740
Fax: (602) 771-2749
E-mail:
kgandhi@azpharmacy.gov
Website: www.azpharmacy.gov
4 A.A.C. 23
Title 4
TITLE 4. PROFESSIONS AND OCCUPATIONS
March 31, 2020
19-2, 1-84 pages
CHAPTER 23. BOARD OF PHARMACY
PREFACE
Under Arizona law, the Department of State, Office of the Secretary of State (Office), accepts state agency rule filings and is the publisher
of Arizona rules. The Office of the Secretary of State does not interpret or enforce rules in the Administrative Code. Questions about rules
should be directed to the state agency responsible for the promulgation of the rule.
Scott Cancelosi, Director
ADMINISTRATIVE RULES DIVISION
ii
RULES
The definition for a rule is provided for under A.R.S. § 41-1001.
“‘Rule’ means an agency statement of general applicability that
implements, interprets, or prescribes law or policy, or describes
the procedures or practice requirements of an agency.”
THE ADMINISTRATIVE CODE
The Arizona Administrative Code is where the official rules of the
state of Arizona are published. The Code is the official codifica-
tion of rules that govern state agencies, boards, and commissions.
The Code is separated by subject into titles. Titles are divided into
chapters. A chapter includes state agency rules. Rules in chapters
are divided into Articles, then Sections. The “R” stands for “rule”
with a sequential numbering and lettering outline separated into
subsections.
Rules are codified quarterly in the Code. Supplement release
dates are printed on the footers of each chapter.
First Quarter: January 1 - March 31
Second Quarter: April 1 - June 30
Third Quarter: July 1 - September 30
Fourth Quarter: October 1 - December 31
For example, the first supplement for the first quarter of 2019 is
cited as Supp. 19-1.
Please note: The Office publishes by chapter, not by individual
rule section. Therefore there might be only a few sections codi-
fied in each chapter released in a supplement. Historical notes at
the end of a section provide an effective date and information
when a rule was last updated.
AUTHENTICATION OF PDF CODE CHAPTERS
The Office began to authenticate chapters of the Administrative
Code in Supp. 18-1 to comply with A.R.S. § 41-1012(B) and
A.R.S. § 5302(1), (2)(d) through (e), and (3)(d) through (e).
A certification verifies the authenticity of each Code chapter
posted as it is released by the Office of the Secretary of State. The
authenticated pdf of the Code includes an integrity mark with a
certificate ID. Users should check the validity of the signature,
especially if the pdf has been downloaded. If the digital signature
is invalid it means the document’s content has been compro-
mised.
HOW TO USE THE CODE
Rules may be in effect before a supplement is released by the
Office. Therefore, the user should refer to issues of the Arizona
Administrative Register for recent updates to rule Sections.
ARIZONA REVISED STATUTE REFERENCES
The Arizona Revised Statutes (A.R.S.) are available online at the
Legislature’s website, www.azleg.gov. An agency’s authority
note to make rules is often included at the beginning of a chapter.
Other Arizona statutes may be referenced in rule under the A.R.S.
acronym.
SESSION LAW REFERENCES
Arizona Session Law references in a chapter can be found at the
Secretary of State’s website, under Services-> Legislative Fil-
ings.
EXEMPTIONS FROM THE APA
It is not uncommon for an agency to be exempt from the steps
outlined in the rulemaking process as specified in the Arizona
Administrative Procedures Act, also known as the APA (Arizona
Revised Statutes, Title 41, Chapter 6, Articles 1 through 10).
Other agencies may be given an exemption to certain provisions
of the Act.
An agency’s exemption is written in law by the Arizona State
Legislature or under a referendum or initiative passed into law by
Arizona voters.
When an agency files an exempt rulemaking package with our
Office it specifies the law exemption in what is called the pre-
amble of rulemaking. The preamble is published in the Register
online at www.azsos.gov/rules, click on the Administrative Reg-
ister link.
Editor’s notes at the beginning of a chapter provide information
about rulemaking sections made by exempt rulemaking. Exempt
rulemaking notes are also included in the historical note at the end
of a rulemaking Section.
The Office makes a distinction to certain exemptions because
some rules are made without receiving input from stakeholders or
the public. Other exemptions may require an agency to propose
exempt rules at a public hearing.
EXEMPTIONS AND PAPER COLOR
At one time the office published exempt rules on either blue or
green paper. Blue meant the authority of the exemption was given
by the Legislature; green meant the authority was determined by a
court order. In 2001 the Office discontinued publishing rules
using these paper colors.
PERSONAL USE/COMMERCIAL USE
This chapter is posted as a public courtesy online, and is for
private use only. Those who wish to use the contents for resale or
profit should contact the Office about Commercial Use fees. For
information on commercial use fees review A.R.S. § 39-121.03
and 1 A.A.C. 1, R1-1-113.
Rhonda Paschal, managing rules editor, assisted with the editing
of this chapter.
Arizona Administrative Code 4 A.A.C. 23
Administrative Rules Division
The Arizona Secretary of State electronically publishes each A.A.C. Chapter with a digital
certificate. The certificate-based signature displays the date and time the document was signed
and can be validated in Adobe Acrobat Reader.
CHAPTER 23. BOARD OF PHARMACY
TITLE 4. PROFESSIONS AND OCCUPATIONS
March 31, 2020 Supp. 20-1 Page 1
Authority: A.R.S. § 32-1904 et seq.
ARTICLE 1. ADMINISTRATION
Section
R4-23-101. General ................................................................. 4
R4-23-102. Meetings .............................................................. 4
R4-23-103. Repealed .............................................................. 4
R4-23-104. Repealed .............................................................. 4
R4-23-105. Repealed .............................................................. 4
R4-23-106. Repealed .............................................................. 4
R4-23-107. Repealed .............................................................. 4
R4-23-108. Repealed .............................................................. 4
R4-23-109. Repealed .............................................................. 4
R4-23-110. Definitions ........................................................... 4
R4-23-111. Notice of Hearing .............................................. 11
R4-23-112. Ex Parte Communications ................................. 11
R4-23-113. Motions .............................................................. 11
R4-23-114. Computing Time ................................................ 12
R4-23-115. Filing Documents .............................................. 12
R4-23-116. Continuing or Expediting a Hearing; Reconvening
a Hearing ............................................................ 12
R4-23-117. Vacating a Hearing ............................................. 12
R4-23-118. Prehearing Conference ...................................... 12
R4-23-119. Subpoenas .......................................................... 12
R4-23-120. Telephonic Testimony ........................................ 13
R4-23-121. Rights and Responsibilities of Parties ............... 13
R4-23-122. Conduct of Hearing ........................................... 13
R4-23-123. Failure of Party to Appear for Hearing .............. 13
R4-23-124. Witnesses; Exclusion from Hearing .................. 13
R4-23-125. Proof .................................................................. 14
R4-23-126. Disruptions ......................................................... 14
R4-23-127. Hearing Record .................................................. 14
R4-23-128. Rehearing or Review and Appeal of Decision ... 14
R4-23-129. Notice of Judicial Appeal; Transmitting the
Transcript ........................................................... 14
ARTICLE 2. PHARMACIST LICENSURE
Section
R4-23-201. General ............................................................... 14
R4-23-202. Licensure by Examination ................................. 15
R4-23-203. Licensure by Reciprocity ................................... 16
R4-23-204. Continuing Education Requirements ................. 17
R4-23-205. Fees .................................................................... 18
ARTICLE 3. INTERN TRAINING AND PHARMACY INTERN
PRECEPTORS
Section
R4-23-301. Intern Licensure ................................................. 19
R4-23-302. Training Site and Pharmacy Intern Preceptors .. 20
R4-23-303. Training Time .................................................... 20
R4-23-304. Reports ............................................................... 20
R4-23-305. Miscellaneous Intern Training Provisions ......... 21
ARTICLE 4. PROFESSIONAL PRACTICES
Section
R4-23-401. Time-frames for Board Approvals and Special
Requests ............................................................. 21
R4-23-402. Pharmacist, Graduate Intern, and Pharmacy Intern
.............................................................................21
R4-23-403. Repealed .............................................................23
R4-23-404. Unethical Practices .............................................23
R4-23-405. Change of Responsibility ...................................24
R4-23-406. Repealed .............................................................24
R4-23-407. Prescription Requirements .................................24
R4-23-407.1. Dispensing an Opioid Antagonist .......................27
R4-23-408. Computer Records ..............................................27
R4-23-409. Returning Drugs and Devices .............................29
R4-23-410. Current Good Compounding Practices ...............29
R4-23-411. Pharmacist-administered or Intern-administered
Immunizations ....................................................31
R4-23-412. Emergency Refill Prescription Dispensing ........ 32
R4-23-413. Temporary Recognition of Nonresident Licensure
.............................................................................32
R4-23-415. Impaired Licensees – Treatment and Rehabilitation
.............................................................................33
R4-23-416. Reserved .............................................................33
R4-23-417. Reserved .............................................................33
R4-23-418. Reserved .............................................................33
R4-23-419. Reserved ............................................................. 33
R4-23-421. Repealed .............................................................33
R4-23-422. Repealed .............................................................33
R4-23-423. Repealed .............................................................33
R4-23-424. Repealed .............................................................33
R4-23-425. Repealed .............................................................33
R4-23-426. Repealed .............................................................33
R4-23-427. Repealed .............................................................33
R4-23-428. Repealed .............................................................34
R4-23-429. Repealed .............................................................34
ARTICLE 5. CONTROLLED SUBSTANCES
PRESCRIPTION MONITORING PROGRAM
New Article 5, consisting of Sections R4-23-501 through R4-
23-505, made effective August 2, 2014 (Supp. 14-2).
Article 5, consisting of Sections R4-23-501 through R4-23-
505, expired effective August 30, 2013 (Supp. 14-1).
Article 5, consisting of Sections R4-23-501 and R4-23-502,
recodified to Article 8 at 9 A.A.R. 4011, effective August 18, 2003
(Supp. 03-3).
Section
R4-23-501. Controlled Substances Prescription Monitoring
(CSPMP) Program Registration and Database
Access .................................................................34
R4-23-502. Requirements for Data Format and Transmission
.............................................................................34
R4-23-503. Access to Controlled Substances Prescription
Monitoring Program Data ...................................35
R4-23-504. Computerized Central Database Tracking System
Task Force ..........................................................35
R4-23-505. Reports ................................................................36
R4-23-506. Repealed .............................................................36
Arizona
Secretary
of State
Digitally signed by
Arizona Secretary
of State
Date: 2020.05.17
14:10:42 -07'00'
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 2 Supp. 20-1 March 31, 2020
ARTICLE 6. PERMITS AND DISTRIBUTION OF DRUGS
Section
R4-23-601. General Provisions ............................................. 36
R4-23-602. Permit Application Process and Time frames .... 37
R4-23-603. Resident-Nonprescription Drugs, Retail ........... 38
R4-23-604. Resident Drug Manufacturer ............................. 39
R4-23-605. Resident Drug Wholesaler Permit ..................... 40
R4-23-606. Resident-Pharmacy Permit: Community, Hospital,
and Limited Service ........................................... 45
R4-23-607. Nonresident Permits .......................................... 46
R4-23-608. Change of Personnel and Responsibility ........... 47
R4-23-609. Pharmacy Area of Community Pharmacy ......... 48
R4-23-610. Community Pharmacy Personnel and Security
Procedures ......................................................... 48
R4-23-611. Pharmacy Facilities ............................................ 49
R4-23-612. Equipment .......................................................... 50
R4-23-613. Procedure for Discontinuing a Pharmacy .......... 50
R4-23-614. Automated Storage and Distribution System .... 51
R4-23-615. Mechanical Storage and Counting Device for a
Drug in Solid, Oral Dosage Form ...................... 51
R4-23-616. Mechanical Counting Device for a Drug in Solid,
Oral Dosage Form ............................................. 52
R4-23-617. Temporary Pharmacy Facilities or Mobile
Pharmacies ......................................................... 53
R4-23-621. Shared Services .................................................. 53
R4-23-622. Reserved ............................................................ 54
R4-23-623. Reserved ............................................................ 54
R4-23-624. Reserved ............................................................ 54
R4-23-625. Reserved ............................................................ 54
R4-23-626. Reserved ............................................................ 54
R4-23-627. Reserved ............................................................ 54
R4-23-628. Reserved ............................................................ 54
R4-23-629. Reserved ............................................................ 54
R4-23-630. Reserved ............................................................ 54
R4-23-631. Reserved ............................................................ 54
R4-23-632. Reserved ............................................................ 54
R4-23-633. Reserved ............................................................ 54
R4-23-634. Reserved ............................................................ 54
R4-23-635. Reserved ............................................................ 54
R4-23-636. Reserved ............................................................ 55
R4-23-637. Reserved ............................................................ 55
R4-23-638. Reserved ............................................................ 55
R4-23-639. Reserved ............................................................ 55
R4-23-640. Reserved ............................................................ 55
R4-23-641. Reserved ............................................................ 55
R4-23-642. Reserved ............................................................ 55
R4-23-643. Reserved ............................................................ 55
R4-23-644. Reserved ............................................................ 55
R4-23-645. Reserved ............................................................ 55
R4-23-646. Reserved ............................................................ 55
R4-23-647. Reserved ............................................................ 55
R4-23-648. Reserved ............................................................ 55
R4-23-649. Reserved ............................................................ 55
R4-23-650. Reserved ............................................................ 55
R4-23-651. Definitions ......................................................... 55
R4-23-652. Hospital Pharmacy Permit ................................. 55
R4-23-653. Personnel: Professional or Technician ............... 55
R4-23-654. Absence of Pharmacist ...................................... 57
R4-23-655. Physical Facility ................................................ 57
R4-23-656. Sanitation and Equipment .................................. 58
R4-23-657. Security .............................................................. 58
R4-23-658. Drug Distribution and Control ........................... 58
R4-23-659. Administration of Drugs .................................... 59
R4-23-660. Investigational Drugs ......................................... 59
R4-23-661. Repealed ............................................................ 60
R4-23-662. Repealed ............................................................ 60
R4-23-663. Repealed .............................................................60
R4-23-664. Repealed .............................................................60
R4-23-665. Reserved .............................................................60
R4-23-666. Reserved .............................................................60
R4-23-667. Reserved .............................................................60
R4-23-668. Reserved .............................................................60
R4-23-669. Reserved .............................................................60
R4-23-670. Sterile Pharmaceutical Products .........................60
R4-23-671. General Requirements for Limited-service
Pharmacy ............................................................61
R4-23-672. Limited-service Correctional Pharmacy .............62
R4-23-673. Limited-service Mail-order Pharmacy ...............63
R4-23-674. Limited-service Long-term Care Pharmacy .......64
R4-23-675. Limited-service Sterile Pharmaceutical Products
Pharmacy ............................................................64
R4-23-676. Third-party Logistics Provider Permit ...............65
R4-23-677. Automated Prescription-dispensing Kiosk Permit .
.............................................................................65
R4-23-678. Reserved .............................................................65
R4-23-679. Reserved .............................................................65
R4-23-680. Reserved .............................................................65
R4-23-681. General Requirements for Limited-service Nuclear
Pharmacy ............................................................65
R4-23-682. Limited-service Nuclear Pharmacy ....................66
R4-23-683. Reserved .............................................................68
R4-23-684. Reserved .............................................................68
R4-23-685. Reserved .............................................................68
R4-23-686. Reserved .............................................................68
R4-23-687. Reserved .............................................................68
R4-23-688. Reserved .............................................................68
R4-23-689. Reserved .............................................................68
R4-23-690. Reserved .............................................................68
R4-23-691. Repealed .............................................................68
R4-23-692. Compressed Medical Gas (CMG) Distributor-
Resident or Nonresident .....................................68
R4-23-693. Durable Medical Equipment (DME) and
Compressed Medical Gas (CMG) Supplier-
Resident or Nonresident .....................................69
ARTICLE 7. NON-PHARMACY LICENSED OUTLETS –
GENERAL PROVISIONS
Section
R4-23-701. Long-term Care Facilities Pharmacy Services:
Consultant Pharmacist ........................................70
R4-23-701.01. Long-term Care Facilities Pharmacy Services:
Provider Pharmacy .............................................70
R4-23-701.02. Long-term Care Facilities Pharmacy Services:
Emergency Drugs ...............................................71
R4-23-701.03. Long-term Care Facilities Pharmacy Services:
Emergency Drug Prescription Order ..................72
R4-23-701.04. Long-term Care Facilities Pharmacy Services:
Automated Dispensing Systems .........................72
R4-23-702. Hospice Inpatient Facilities ................................73
R4-23-703. Assisted Living Facilities ...................................73
R4-23-704. Customized Patient Medication Packages ..........74
R4-23-705. Repealed .............................................................74
R4-23-706. Repealed .............................................................74
R4-23-707. Repealed .............................................................74
R4-23-708. Repealed .............................................................74
R4-23-709. Repealed .............................................................74
ARTICLE 8. DRUG CLASSIFICATION
Article 8, consisting of Sections R4-23-801 and R4-23-802,
recodified from Article 5 at 9 A.A.R. 4011, effective August 18, 2003
(Supp. 03-3).
Article 8, consisting of Sections R4-23-801 through R4-23-
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 3
804, repealed effective November 4, 1998 (Supp. 98-4).
Section
R4-23-801. Repealed ............................................................ 74
R4-23-802. Veterinary ........................................................... 74
R4-23-803. Repealed ............................................................ 75
R4-23-804. Repealed ............................................................ 75
ARTICLE 9. PENALTIES AND MISCELLANEOUS
Section
R4-23-901. Penalty for Violations ........................................ 75
ARTICLE 10. UNIFORM CONTROLLED SUBSTANCES
AND DRUG OFFENSES
Section
R4-23-1001. Repealed ............................................................ 75
R4-23-1002. Repealed ............................................................ 75
R4-23-1003. Records and Order Forms .................................. 75
R4-23-1004. Repealed ............................................................ 76
R4-23-1005. Substances Excepted from the Schedules of
Controlled Substances ....................................... 76
R4-23-1006. Substances Excepted from Drug Offenses ........ 76
ARTICLE 11. PHARMACY TECHNICIANS
Article 11, consisting of R4-23-1101 through R4-23-1105,
made by final rulemaking at 10 A.A.R. 1192, effective May 1, 2004
(Supp. 04-1).
Section
R4-23-1101. Licensure and Eligibility ................................... 76
R4-23-1102. Pharmacy Technician Licensure ........................ 76
R4-23-1103. Pharmacy Technician Trainee Licensure ........... 77
R4-23-1104. Pharmacy Technicians and Pharmacy Technician
Trainees .............................................................. 77
R4-23-1104.01 Technology-assisted Verification of Product ..... 78
R4-23-1105. Pharmacy Technician Trainee Training Program,
Pharmacy Technician Drug Compounding Training
Program, and Alternative Pharmacy Technician
Training .............................................................. 79
R4-23-1106. Continuing Education Requirements ..................80
ARTICLE 12. PRESCRIPTION MEDICATION DONATION
PROGRAM
Article 12, consisting of R4-23-1201 through R4-23-1211,
made by final rulemaking at 14 A.A.R. 4320, effective January 3,
2009 (Supp. 08-4).
Section
R4-23-1101. Licensure and Eligibility ....................................76
R4-23-1102. Pharmacy Technician Licensure .........................76
R4-23-1103. Pharmacy Technician Trainee Licensure ............77
R4-23-1104. Pharmacy Technicians and Pharmacy Technician
Trainees ..............................................................77
R4-23-1104.01 Technology-assisted Verification of Product ......78
R4-23-1105. Pharmacy Technician Trainee Training Program,
Pharmacy Technician Drug Compounding Training
Program, and Alternative Pharmacy Technician
Training ..............................................................79
R4-23-1106. Continuing Education Requirements ..................80
ARTICLE 12. PRESCRIPTION MEDICATION DONATION
PROGRAM
R4-23-1201. Eligibility Requirements for Participation in the
Program ..............................................................81
R4-23-1202. Donating Medications ........................................81
R4-23-1203. Eligible Prescription Medications ......................81
R4-23-1204. Eligibility Requirements to Receive Donated
Prescription Medications ....................................81
R4-23-1205. Donor Form ........................................................82
R4-23-1206. Recipient Form ...................................................82
R4-23-1207. Recordkeeping ....................................................82
R4-23-1208. Handling Fee ......................................................83
R4-23-1209. Policies and Procedures ......................................83
R4-23-1210. Dispensing Donated Prescription Medications ..83
R4-23-1211. Responsibilities of the Physician-in-charge or
Pharmacist-in-charge of a Participating Physician’s
Office, Pharmacy, or Health Care Institution .....84
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 4 Supp. 20-1 March 31, 2020
ARTICLE 1. ADMINISTRATION
R4-23-101. General
A. 4 A.A.C. 23 applies to all actions and proceedings of the
Board and shall be deemed a part of the record in any Board
action or proceeding without formal introduction of, or refer-
ence to the rules. A party to a Board action is deemed to have
knowledge of the rules. The Board office shall provide a copy
of the rules:
1. To each license applicant who submits a completed appli-
cation packet; and
2. To each permit applicant during the final compliance
inspection after the Board approves the permit applica-
tion.
B. The Board, within its jurisdiction, may, in the interest of jus-
tice, excuse the failure of any person to comply with the rules.
C. The Board, within its jurisdiction, may grant an extension of
time within which to comply with any rule when it deems the
extension to be in the interest of justice.
Historical Note
Former Rules 1.1000, 1.1200, and 1.1300; Amended
effective August 23, 1978 (Supp. 78-4). Amended by
final rulemaking at 10 A.A.R. 1132, effective May 1,
2004 (Supp. 04-1); Historical Note updated (Supp. 06-2).
R4-23-102. Meetings
A. The Board shall hold not less than four meetings per fiscal
year to conduct general business and interview permit and
license applicants.
B. A special meeting of the Board may be held at any time sub-
ject to the call of the President or a majority of the Board
members and in compliance with the notification requirements
of A.R.S. § 38-431.02.
Historical Note
Former Rules 1.2100, 1.2200, 1.2300, and 1.2400.
Amended by final rulemaking at 7 A.A.R. 2143, effective
May 1, 2001 (Supp. 01-2).
R4-23-103. Repealed
Historical Note
Former Rules 1.3100, 1.3200, 1.3300, and 1.3400;
Amended subsection (C) effective August 9, 1983
(Supp. 83-4). Section repealed by final rulemaking at 10
A.A.R. 1132, effective May 1, 2004 (Supp. 04-1); Histor-
ical Note updated (Supp. 06-2).
R4-23-104. Repealed
Historical Note
Former Rules 1.4011, 1.4110, 1.4120, 1.4200, 1.4210,
1.4220, 1.4300, 1.4400, 1.5500, 1.5600, 1.5700, and
1.4500; Amended effective August 23, 1978 (Supp. 78-
5); Amended by deleting subsection (B) and renumbering
subsections (C) through (J) as subsections (B) through (I)
effective August 9, 1983 (Supp. 83-4). Amended effec-
tive February 8, 1991 (Supp. 91-1). Section repealed by
final rulemaking at 10 A.A.R. 1132, effective May 1,
2004 (Supp. 04-1); Historical Note updated (Supp. 06-2).
R4-23-105. Repealed
Historical Note
Former Rules 1.5100, 1.5200, 1.5300, and 1.5400;
Amended subsection (B) effective August 9, 1983
(Supp. 83-4). Section repealed by final rulemaking at 10
A.A.R. 1132, effective May 1, 2004 (Supp. 04-1); Histor-
ical Note updated (Supp. 06-2).
R4-23-106. Repealed
Historical Note
Former Rules 1.5800 and 1.5900. Section repealed by
final rulemaking at 10 A.A.R. 1132, effective May 1,
2004 (Supp. 04-1); Historical Note updated (Supp. 06-2).
R4-23-107. Repealed
Historical Note
Former Rules 1.5910, 1.5920, 1.5921, and 1.5922. Sec-
tion repealed by final rulemaking at 10 A.A.R. 1132,
effective May 1, 2004 (Supp. 04-1); Historical Note
updated (Supp. 06-2).
R4-23-108. Repealed
Historical Note
Former Rule 1.5930. Section repealed by final rulemak-
ing at 10 A.A.R. 1132, effective May 1, 2004 (Supp. 04-
1); Historical Note updated (Supp. 06-2).
R4-23-109. Repealed
Historical Note
Former Rules 1.7100, 1.7200, and 1.7300. Amended
effective July 14, 1977 (Supp. 77-4). Amended effective
February 8, 1991 (Supp. 91-1). Section repealed by final
rulemaking at 10 A.A.R. 1132, effective May 1, 2004
(Supp. 04-1); Historical Note updated (Supp. 06-2).
R4-23-110. Definitions
In addition to definitions in A.R.S. § 32-1901, the following defini-
tions apply to this Chapter:
“Active ingredient” means any component that furnishes phar-
macological activity or other direct effect in the diagnosis,
cure, mitigation, treatment, or prevention of disease or that
affects the structure or any function of the body of man or
other animals. The term includes those components that may
undergo chemical change in the manufacture of the drug, that
are present in the finished drug product in a modified form,
and that furnish the specified activity or effect.
“AHCCCS” means the Arizona Health Care Cost Containment
System.
“Annual family income” means the combined yearly gross
earned income and unearned income of all adult individuals
within a family unit.
“Approved course in pharmacy law” means a continuing edu-
cation activity that addresses practice issues related to state or
federal pharmacy statutes, rules, or regulations.
“Approved Provider” means an individual, institution, organi-
zation, association, corporation, or agency that is approved by
the Accreditation Council for Pharmacy Education (ACPE) in
accordance with ACPE’s policy and procedures or by the
Board as meeting criteria indicative of the ability to provide
quality continuing education.
“Assisted living facility” means a residential care institution as
defined in A.R.S. § 36-401.
“Authentication of product history” means identifying the pur-
chasing source, the ultimate fate, and any intermediate han-
dling of any component of a radiopharmaceutical or other
drug.
“Automated dispensing system” means a mechanical system
in a long-term care facility that performs operations or activi-
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 5
ties, other than compounding or administration, relative to the
storage, packaging, counting, labeling, and dispensing of med-
ications, and which collects, controls, and maintains all trans-
action information.
“Automated storage and distribution system” means a
mechanical system that performs operations or activities other
than counting, compounding, or administration, relative to the
storage, packaging, or distributing of drugs or devices and that
collects, controls, and maintains all transaction information.
“Batch” means a specific quantity of drug that has uniform
character and quality, within specified limits, and is produced
according to a single manufacturing order during the same
cycle of manufacture.
“Beyond-use date” means:
A date determined by a pharmacist and placed on a pre-
scription label at the time of dispensing to indicate a time
beyond which the contents of the prescription are not rec-
ommended to be used; or
A date determined by a pharmacist and placed on a com-
pounded pharmaceutical product’s label at the time of
preparation as specified in R4-23-410(B)(3)(d), R4-23-
410(I)(6)(e), or R4-23-410(J)(1)(d) to indicate a time
beyond which the compounded pharmaceutical product is
not recommended to be used.
“Biological safety cabinet” means a containment unit suitable
for the preparation of low to moderate risk agents when there
is a need for protection of the product, personnel, and environ-
ment, consistent with National Sanitation Foundation (NSF)
standards, published in the National Sanitation Foundation
Standard 49, Class II (Laminar Flow) Biohazard Cabinetry,
NSF International P. O. Box 130140, Ann Arbor, MI, revised
June 1987 edition, (and no future amendments or editions),
incorporated by reference and on file with the Board.
“Care-giver” means a person who cares for someone who is
sick or disabled or an adult who cares for an infant or child and
includes a patient’s husband, wife, son, daughter, mother,
father, sister, brother, legal guardian, nurse, or medical practi-
tioner.
“Change of ownership,” as used in A.R.S. § 32-1901.01(A),
means a change of at least 30 percent in voting stock or vested
interest that has direct operational oversight.
“Community pharmacy” means any place under the direct
supervision of a pharmacist where the practice of pharmacy
occurs or where prescription orders are compounded and dis-
pensed other than a hospital pharmacy or a limited service
pharmacy.
“Component” means any ingredient used in compounding or
manufacturing drugs in dosage form, including an ingredient
that may not appear in the finished product.
“Compounding and dispensing counter” means a pharmacy
counter working area defined in this Section where a pharma-
cist, intern, pharmacy technician, or pharmacy technician
trainee under the supervision of a pharmacist compounds,
mixes, combines, counts, pours, or prepares and packages a
prescription medication to dispense an individual prescription
order or prepackages a drug for future dispensing.
“Computer system” means an automated data-processing sys-
tem that uses a programmable electronic device to store,
retrieve, and process data.
“Computer system audit” means an accounting method,
involving multiple single-drug usage reports and audits, used
to determine a computer system’s ability to store, retrieve, and
process original and refill prescription dispensing information.
“Contact hour” means 50 minutes of participation in a continu-
ing education activity sponsored by an Approved Provider.
“Container” means:
A receptacle, as described in the official compendium or
the federal act, that is used in manufacturing or com-
pounding a drug or in distributing, supplying, or dispens-
ing the finished dosage form of a drug; or
A metal receptacle designed to contain liquefied or
vaporized compressed medical gas and used in manufac-
turing, transfilling, distributing, supplying, or dispensing
a compressed medical gas.
“Continuing education” means a structured learning process
required of a licensee to maintain licensure that includes study
in the general areas of socio-economic and legal aspects of
health care; the properties and actions of drugs and dosage
forms; etiology, characteristics and therapeutics of disease sta-
tus; or pharmacy practice.
“Continuing education activity” means continuing education
obtained through an institute, seminar, lecture, conference,
workshop, mediated instruction, programmed learning course,
or postgraduate study in an accredited college or school of
pharmacy.
“Continuing education unit” or “CEU” means 10 contact hours
of participation in a continuing education activity sponsored
by an Approved Provider.
“Continuous quality assurance program” or “CQA program”
means a planned process designed by a pharmacy permittee to
identify, evaluate, and prevent medication errors.
“Correctional facility” has the same meaning as in A.R.S. §§
13-2501 and 31-341.
“CRT” means a cathode ray tube or other mechanism used to
view information produced or stored by a computer system.
“CSPMP” means the Controlled Substances Prescription Mon-
itoring Program established under A.R.S. Title 36, Chapter 28.
“Current good compounding practices” means the minimum
standards for methods used in, and facilities or controls used
for, compounding a drug to ensure that the drug has the iden-
tity and strength and meets the quality and purity characteris-
tics it is represented to possess.
“Current good manufacturing practice” means the minimum
standard for methods used in, and facilities or controls used for
manufacturing, processing, packing, or holding a drug to
ensure that the drug meets the requirements of the federal act
as to safety, and has the identity and strength and meets the
quality and purity characteristics it is represented to possess.
“Cytotoxic” means a pharmaceutical that is capable of killing
living cells.
“Day” means a calendar day unless otherwise specified.
“DEA” means the Drug Enforcement Administration as
defined in A.R.S. § 32-1901.
“Declared disaster areas” means areas designated by the gov-
ernor or by a county, city, or town under A.R.S. § 32-1910 as
those areas that have been adversely affected by a natural
disaster or terrorist attack and require extraordinary measures
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 6 Supp. 20-1 March 31, 2020
to provide adequate, safe, and effective health care for the
affected population.
“Delinquent license” means a pharmacist, intern, or pharmacy
technician license the Board suspends for failure to renew or
pay all required fees on or before the date the renewal is due.
“Dietary supplement or food supplement,” as used in A.R.S. §
32-1904(B), means a product (other than tobacco) that:
Is intended to supplement the diet that contains one or
more of the following dietary ingredients: a vitamin, min-
eral, herb or other botanical, amino acid, dietary sub-
stance for use by humans to supplement the diet by
increasing the total daily intake, or concentrate, metabo-
lite, constituent, extract, or combinations of these ingredi-
ents;
Is intended for ingestion in pill, capsule, tablet, or liquid
form;
Is not represented for use as a conventional food or as the
sole item of a meal or diet; and
Is labeled as a “dietary supplement” or “food supple-
ment.”
“Digital signature” has the same meaning as in A.R.S. § 41-
132(E).
“Dispensing pharmacist” means a pharmacist who, in the pro-
cess of dispensing a prescription medication after the complete
preparation of the prescription medication and before delivery
of the prescription medication to a patient or patient’s agent,
verifies, checks, and initials the prescription medication label,
as required in R4-23-402(A).
“Drug sample” means a unit of a prescription drug that a man-
ufacturer provides free of charge to promote the sale of the
drug.
“Durable medical equipment” or “DME” means technologi-
cally sophisticated medical equipment that may be used by a
patient or consumer in a home or residence. DME may be pre-
scription-only devices as defined in A.R.S. § 32-1901. DME
includes:
Air-fluidized beds,
Apnea monitors,
Blood glucose monitors and diabetic testing strips,
Continuous Positive Airway Pressure (CPAP) machines,
Electronic and computerized wheelchairs and seating sys-
tems,
Feeding pumps,
Home phototherapy devices,
Hospital beds,
Infusion pumps,
Medical oxygen and oxygen delivery systems excluding
compressed medical gases,
Nebulizers,
Respiratory disease management devices,
Sequential compression devices,
Transcutaneous electrical nerve stimulation (TENS) unit,
and
Ventilators.
“Earned income” means monetary payments received by an
individual as a result of work performed or rental property
owned or leased by the individual, including:
Wages,
Commissions and fees,
Salaries and tips,
Profit from self-employment,
Profit from rent received from a tenant or boarder, and
Any other monetary payments received by an individual
for work performed or rental of property.
“Electronic signature” has the same meaning as in A.R.S. §
44-7002.
“Eligible patient” means a patient who a pharmacist deter-
mines is eligible to receive an immunization using profes-
sional judgment after consulting with the patient regarding the
patient’s current health condition, recent health condition, and
allergies.
“Emergency drug supply unit” means those drugs that may be
required to meet the immediate and emergency therapeutic
needs of long-term care facility residents and hospice inpatient
facility patients, and which are not available from any other
authorized source in sufficient time to prevent risk of harm to
residents or patients.
“Extreme emergency” means the occurrence of a fire, water
leak, electrical failure, public disaster, or other catastrophe
constituting an imminent threat of physical harm to pharmacy
personnel or patrons.
“Family unit” means:
A group of individuals residing together who are related
by birth, marriage, or adoption; or
An individual who:
Does not reside with another individual; or
Resides only with another individual or group of
individuals to whom the individual is unrelated by
birth, marriage, or adoption.
“FDA” means the Food and Drug Administration, a federal
agency within the United States Department of Health and
Human Services, established to set safety and quality stan-
dards for foods, drugs, cosmetics, and other consumer prod-
ucts.
“Health care decision maker” has the same meaning as in
A.R.S. § 12-2291.
“Health care institution” has the same meaning as in A.R.S. §
36-401.
“Hospice inpatient facility” means a health care institution
licensed under A.R.S. § 36-401 and Article 8 that provides
hospice services to a patient requiring inpatient services.
“Immediate notice” means a required notice sent by mail, fax,
or electronic mail to the Board Office within 24 hours.
“Immunizations training program” means an immunization
training program for pharmacists and interns that meets the
requirements of R4-23-411(E).
“Inactive ingredient” means any component other than an
“active ingredient” present in a drug.
“Internal test assessment” means performing quality assurance
or other procedures necessary to ensure the integrity of a test.
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 7
“ISO Class 5 environment” means an atmospheric environ-
ment that complies with the ISO/TC209 International Clean-
room Standards, specifically ANSI/IEST/ISO-14644-1:1999:
Cleanrooms and associated controlled environments--Part 1:
Classification of air cleanliness, first edition dated May 1,
1999, (and no future amendments or editions), incorporated by
reference and on file in the Board office.
“ISO Class 7 environment” means an atmospheric environ-
ment that complies with the ISO/TC209 International Clean-
room Standards, specifically ANSI/IEST/ISO-14644-1:1999:
Cleanrooms and associated controlled environments--Part 1:
Classification of air cleanliness, first edition dated May 1,
1999, (and no future amendments or editions), incorporated by
reference and on file in the Board office.
“Licensed health care professional” means an individual who
is licensed and regulated under A.R.S. Title 32, Chapter 7, 11,
13, 14, 15, 16, 17, 18, 25, 29, or 35.
“Limited-service correctional pharmacy” means a limited-ser-
vice pharmacy, as defined in A.R.S. § 32-1901, that:
Holds a current Board permit under A.R.S. § 32-1931;
Is located in a correctional facility; and
Uses pharmacists, interns, and support personnel to com-
pound, produce, dispense, and distribute drugs.
“Limited-service long-term care pharmacy” means a limited-
service pharmacy, as defined in A.R.S. § 32-1901, that holds a
current Board-issued permit and dispenses prescription medi-
cation or prescription-only devices to patients in long-term
care facilities.
“Limited-service mail-order pharmacy” means a limited-ser-
vice pharmacy, as defined in A.R.S. § 32-1901, that holds a
current Board permit under A.R.S. § 32-1931 and dispenses a
majority of its prescription medication or prescription-only
devices by mailing or delivering the prescription medication or
prescription-only device to an individual by the United States
mail, a common or contract carrier, or a delivery service.
“Limited-service nuclear pharmacy” means a limited-service
pharmacy, as defined in A.R.S. § 32-1901, that holds a current
Board permit under A.R.S. § 32-1931 and provides radiophar-
maceutical services.
“Limited-service pharmacy permittee” means a person who
holds a current limited-service pharmacy permit in compliance
with A.R.S. §§ 32-1929, 32-1930, 32-1931, and A.A.C. R4-
23-606.
“Limited-service sterile pharmaceutical products pharmacy”
means a limited-service pharmacy, as defined in A.R.S. § 32-
1901, that holds a current Board permit under A.R.S. § 32-
1931 and dispenses a majority of its prescription medication or
prescription-only devices as sterile pharmaceutical products.
“Long-term care consultant pharmacist” means a pharmacist
providing consulting services to a long-term care facility.
“Long-term care facility” or “LTCF” means a nursing care
institution as defined in A.R.S. § 36-401.
“Lot” means a batch or any portion of a batch of a drug, or if a
drug produced by a continuous process, an amount of drug
produced in a unit of time or quantity in a manner that assures
its uniformity. In either case, a lot is identified by a distinctive
lot number and has uniform character and quality with speci-
fied limits.
“Lot number” or “control number” means any distinctive com-
bination of letters or numbers, or both, from which the com-
plete history of the compounding or manufacturing, control,
packaging, and distribution of a batch or lot of a drug can be
determined.
“Low-income subsidy” means Medicare-provided assistance
that may partially or fully cover the costs of drugs and is based
on the income of an individual and, if applicable, the individ-
ual’s spouse.
“Materials approval unit” means any organizational element
having the authority and responsibility to approve or reject
components, in-process materials, packaging components, and
final products.
“Mechanical counting device for a drug in solid, oral dosage
form” means a mechanical device that counts drugs in solid,
oral dosage forms for dispensing and includes an electronic
balance when used to count drugs.
“Mechanical storage and counting device for a drug in solid,
oral dosage form” means a mechanical device that stores and
counts and may package or label drugs in solid, oral dosage
forms for dispensing.
“Mediated instruction” means information transmitted via
intermediate mechanisms such as audio or video tape or tele-
phone transmission.
“Medical practitioner-patient relationship” means that before
prescribing, dispensing, or administering a prescription-only
drug, prescription-only device, or controlled substance to a
person, a medical practitioner, as defined in A.R.S. § 32-1901,
shall first conduct a physical examination of that person or
have previously conducted a physical examination. This sub-
division does not apply to:
A medical practitioner who provides temporary patient
supervision on behalf of the patient’s regular treating
medical practitioner;
Emergency medical situations as defined in A.R.S. § 41-
1831;
Prescriptions written to prepare a patient for a medical
examination; or
Prescriptions written, prescription-only drugs, prescrip-
tion-only devices, or controlled substances issued for use
by a county or tribal public health department for immu-
nization programs, emergency treatment, in response to
an infectious disease investigation, public health emer-
gency, infectious disease outbreak or act of bioterrorism.
For purposes of this subsection, “bioterrorism” has the
same meaning as in A.R.S. § 36-781.
“Medicare” means a federal health insurance program estab-
lished under Title XVIII of the Social Security Act.
“Medication error” means any unintended variation from a
prescription or medication order. Medication error does not
include any variation that is corrected before the medication is
dispensed to the patient or patient’s care-giver, or any variation
allowed by law.
“Mobile pharmacy” means a pharmacy that is self-propelled or
movable by another vehicle that is self-propelled.
“MPJE” means Multistate Pharmacy Jurisprudence Examina-
tion, a Board-approved national pharmacy law examination
written and administered in cooperation with NABP.
“NABP” means National Association of Boards of Pharmacy.
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 8 Supp. 20-1 March 31, 2020
“NABPLEX” means National Association of Boards of Phar-
macy Licensure Examination.
“NAPLEX” means North American Pharmacist Licensure
Examination.
“Order” means either of the following:
A prescription order as defined in A.R.S. § 32-1901; or
A medication order as defined in A.A.C. R4-23-651.
“Other designated personnel” means a non-pharmacist indi-
vidual who is permitted in the pharmacy area, for a limited
time, under the direct supervision of a pharmacist, to perform
non-pharmacy related duties, such as trash removal, floor
maintenance, and telephone or computer repair.
“Outpatient” means an individual who is not a residential
patient in a health care institution.
“Outpatient setting” means a location that provides medical
treatment to an outpatient.
“Patient profile” means a readily retrievable, centrally located
information record that contains patient demographics, aller-
gies, and medication profile.
“Pharmaceutical patient care services” means the provision of
drug selection, drug utilization review, drug administration,
drug therapy monitoring, and other drug-related patient care
services intended to achieve outcomes related to curing or pre-
venting a disease, eliminating or reducing a patient’s symp-
toms, or arresting or slowing a disease process, by identifying
and resolving or preventing potential and actual drug-related
problems.
“Pharmaceutical product” means a medicinal drug.
“Pharmacy counter working area” means a clear and continu-
ous working area that contains no major obstacles such as a
desktop computer, computer monitor, computer keyboard,
external computer drive device, printer, fax machine, phar-
macy balance, typewriter, or pill-counting machine, but may
contain individual documents or prescription labels, pens, pre-
scription blanks, refill log, pill-counting tray, spatula, stapler,
or other similar items necessary for the prescription-filling
process.
“Pharmacy law continuing education” means a continuing
education activity that addresses practice issues related to state
or federal pharmacy statutes, rules, or regulations, offered by
an Approved Provider.
“Pharmacy permittee” means a person who holds a current
pharmacy permit that complies with A.R.S. §§ 32-1929, 32-
1930, 32-1931, 32-1934, and R4-23-606 and R4-23-652.
“Physician” means a medical practitioner licensed under
A.R.S. Title 32, Chapter 13 or 17.
“Physician-in-charge” means a physician who is responsible to
the Board for all aspects of a prescription medication donation
program required in A.R.S. § 32-1909 and operated in the phy-
sician’s office or in a health care institution.
“Poverty level” means the annual family income for a family
unit of a particular size, as specified in the poverty guidelines
updated annually in the Federal Register by the U.S. Depart-
ment of Health and Human Services.
“Precursor chemical” means a precursor chemical I as defined
in A.R.S. § 13-3401(26) and a precursor chemical II as defined
in A.R.S. § 13-3401(27).
“Prepackaged drug” means a drug that is packaged in a fre-
quently prescribed quantity, labeled in compliance with A.R.S.
§§ 32-1967 and 32-1968, stored, and subsequently dispensed
by a pharmacist or intern under the supervision of a pharma-
cist, who verifies at the time of dispensing that the drug con-
tainer is properly labeled, in compliance with A.R.S. § 32-
1968, for the patient.
“Prep area” means a specified area either within an ISO class 7
environment or adjacent to but outside an ISO class 7 environ-
ment that:
Allows the assembling of necessary drugs, supplies, and
equipment for compounding sterile pharmaceutical prod-
ucts, but does not allow the use of paper products such as
boxes or bulk drug storage;
Allows personnel to don personnel protective clothing,
such as gown, gloves, head cover, and booties before
entering the clean compounding area; and
Is a room or a specified area within a room, such as an
area specified by a line on the floor.
“Primary care provider” means the medical practitioner who is
treating an individual for a disease or medical condition.
“Proprietor” means the owner of a business permitted by the
Board under A.R.S. §§ 32-1929, 32-1930, 32-1931, and 32-
1934.
“Provider pharmacy” means a pharmacy that contracts with a
long-term care facility to supply prescription medication or
other services for residents of a long-term care facility.
“Radiopharmaceutical” means any drug that emits ionizing
radiation and includes:
Any nonradioactive reagent kit, nuclide generator, or
ancillary drug intended to be used in the preparation of a
radiopharmaceutical, but does not include drugs such as
carbon-containing compounds or potassium-containing
salts, that contain trace quantities of naturally occurring
radionuclides; and
Any biological product that is labeled with a radionuclide
or intended to be labeled with a radionuclide.
“Radiopharmaceutical quality assurance” means performing
and interpreting appropriate chemical, biological, and physical
tests on radiopharmaceuticals to determine the suitability of
the radiopharmaceutical for use in humans and animals.
Radiopharmaceutical quality assurance includes internal test
assessment, authentication of product history, and appropriate
record retention.
“Radiopharmaceutical services” means procuring, storing,
handling, compounding, preparing, labeling, quality assurance
testing, dispensing, distributing, transferring, recordkeeping,
and disposing of radiochemicals, radiopharmaceuticals, and
ancillary drugs. Radiopharmaceutical services include quality
assurance procedures, radiological health and safety proce-
dures, consulting activities associated with the use of radio-
pharmaceuticals, and any other activities required for the
provision of pharmaceutical care.
“Red C stamp” means a device used with red ink to imprint an
invoice with a red letter C at least one inch high, to make an
invoice of a Schedule III through IV controlled substance, as
defined in A.R.S. § 36-2501, readily retrievable, as required
by state and federal rules.
“Refill” means other than the original dispensing of the pre-
scription order, dispensing a prescription order in the same
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 9
quantity originally ordered or in multiples of the originally
ordered quantity when specifically authorized by the pre-
scriber, if the refill is authorized by the prescriber:
In the original prescription order;
By an electronically transmitted refill order that the phar-
macist promptly documents and files; or
By an oral refill order that the pharmacist promptly docu-
ments and files.
“Regulated chemical” means the same as in A.R.S. § 13-
3401(30).
“Remodel” means to alter structurally the pharmacy area or
location.
“Remote drug storage area” means an area that is outside the
premises of the pharmacy, used for the storage of drugs,
locked to deny access by unauthorized persons, and secured
against the use of force.
“Resident” means:
An individual admitted to and living in a long-term care
facility or an assisted living facility,
An individual who has a place of habitation in Arizona
and lives in Arizona as other than a tourist, or
A person that owns or operates a place of business in Ari-
zona.
“Responsible person” means the owner, manager, or other
employee who is responsible to the Board for a permitted
establishment’s compliance with the laws and administrative
rules of this state and of the federal government pertaining to
distribution of drugs, devices, precursor chemicals, and regu-
lated chemicals. Nothing in this definition relieves other indi-
viduals from the responsibility to comply with state and
federal laws and administrative rules.
“Score transfer” means the process that enables an applicant to
take the NAPLEX in a jurisdiction and be eligible for licensure
by examination in other jurisdictions.
“Security features” means attributes incorporated into the
paper of a prescription order, referenced in A.R.S. § 32-
1968(A)(4), that are approved by the Board or its staff and
include one or more of the following designed to prevent
duplication or aid the authentication of a paper document: laid
lines, enhanced laid lines, thermochromic ink, artificial water-
mark, fluorescent ink, chemical void, persistent void, penetrat-
ing numbers, high-resolution border, high-resolution latent
images, micro-printing, prismatic printing, embossed images,
abrasion ink, holograms, and foil stamping.
“Shared order filling” means the following:
Preparing, packaging, compounding, or labeling an order,
or any combination of these functions, that are performed
by:
A person with a current Arizona Board license, located at
an Arizona pharmacy, on behalf of and at the request of
another resident or nonresident pharmacy; or
A person, located at a nonresident pharmacy, on behalf of
and at the request of an Arizona pharmacy; and
Returning the filled order to the requesting pharmacy for
delivery to the patient or patient’s care-giver or, at the
request of this pharmacy, directly delivering the filled
order to the patient.
“Shared order processing” means the following:
Interpreting the order, performing order entry verifica-
tion, drug utilization review, drug compatibility and drug
allergy review, final order verification, and when neces-
sary, therapeutic intervention, or any combination of
these order processing functions, that are performed by:
A pharmacist or intern, under pharmacist supervi-
sion, with a current Arizona Board license, located
at an Arizona pharmacy, on behalf of and at the
request of another resident or nonresident pharmacy:
or
A pharmacist or intern, under pharmacist supervi-
sion, located at a nonresident pharmacy, on behalf of
and at the request of an Arizona pharmacy; and
After order processing is completed, returning the
processed order to the requesting pharmacy for order
filling and delivery to the patient or patient’s care-
giver or, at the request of this pharmacy, returning
the processed order to another pharmacy for order
filling and delivery to the patient or patient’s care-
giver.
“Shared services” means shared order filling or shared order
processing, or both.
“Sight-readable” means that an authorized individual is able to
examine a record and read its information from a CRT, micro-
fiche, microfilm, printout, or other method acceptable to the
Board or its designee.
“Single-drug audit” means an accounting method that deter-
mines the numerical and percentage difference between a
drug’s beginning inventory plus purchases and ending inven-
tory plus sales.
“Single-drug usage report” means a computer system printout
of original and refill prescription order usage information for a
single drug.
“Standard-risk sterile pharmaceutical product” means a sterile
pharmaceutical product compounded from sterile commercial
drugs using sterile commercial devices or a sterile pharmaceu-
tical optic or ophthalmic product compounded from non-ster-
ile ingredients.
“State of emergency” means a governmental declaration
issued under A.R.S. § 32-1910 as a result of a natural disaster
or terrorist attack that results in individuals being unable to
refill existing prescriptions.
“Sterile pharmaceutical product” means a medicinal drug free
from living biological organisms.
“Strength” means:
The concentration of the drug substance (for example,
weight/weight, weight/volume, or unit dose/volume
basis); or
The potency, that is, the therapeutic activity of a drug
substance as indicated by bioavailability tests or by con-
trolled clinical data (expressed, for example, in terms of
unity by reference to a standard).
“Substantial-risk sterile pharmaceutical product” means a ster-
ile pharmaceutical product compounded as a parenteral or
injectable dosage form from non-sterile ingredients.
“Supervision” means a pharmacist is present, assumes legal
responsibility, and has direct oversight of activities relating to
acquiring, preparing, distributing, administering, and selling
prescription medications by interns, pharmacy technicians, or
pharmacy technician trainees and when used in connection
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 10 Supp. 20-1 March 31, 2020
with the intern training requirements means that, in a phar-
macy where intern training occurs, an intern preceptor
assumes the primary responsibility of teaching the intern
during the entire period of the training.
“Supplying” means selling, transferring, or delivering to a
patient or a patient’s agent one or more doses of:
A nonprescription drug in the manufacturer’s original
container for subsequent use by the patient, or
A compressed medical gas in the manufacturer’s or com-
pressed medical gas distributor’s original container for
subsequent use by the patient.
“Support personnel” means an individual, working under the
supervision of a pharmacist, trained to perform clerical duties
associated with the practice of pharmacy, including cashiering,
bookkeeping, pricing, stocking, delivering, answering non-
professional telephone inquiries, and documenting third-party
reimbursement. Support personnel shall not perform the tasks
of a pharmacist, intern, pharmacy technician, or pharmacy
technician trainee.
“Temporary pharmacy facility” means a facility established as
a result of a declared state of emergency to temporarily pro-
vide pharmacy services within or adjacent to declared disaster
areas.
“Tourist” means an individual who is living in Arizona but
maintains a place of habitation outside of Arizona and lives
outside of Arizona for more than six months during a calendar
year.
“Transfill” means a manufacturing process by which one or
more compressed medical gases are transferred from a bulk
container to a properly labeled container for subsequent distri-
bution or supply.
“Unearned income” means monetary payment received by an
individual that is not compensation for work performed or
rental of property owned or leased by the individual, includ-
ing:
Unemployment insurance,
Workers’ compensation,
Disability payments,
Payments from the Social Security Administration,
Payments from public assistance,
Periodic insurance or annuity payments,
Retirement or pension payments,
Strike benefits from union funds,
Training stipends,
Child support payments,
Alimony payments,
Military family allotments,
Regular support payments from a relative or other indi-
vidual not residing in the household,
Investment income,
Royalty payments,
Periodic payments from estates or trusts, and
Any other monetary payments received by an individual
that are not:
As a result of work performed or rental of property
owned by the individual,
Gifts,
Lump-sum capital gains payments,
Lump-sum inheritance payments,
Lump-sum insurance payments, or
Payments made to compensate for personal injury.
“Verified signature” or “signature verifying” means in relation
to a Board license or permit application or report, form, or
agreement, the hand-written or electronic signature of an indi-
vidual who, by placing a hand-written or electronic signature
on a hard-copy or electronic license or permit application or
report, form, or agreement agrees with and verifies that the
statements and information within or attached to the license or
permit application or report, form, or agreement are true in
every respect and that inaccurate reporting can result in denial
or loss of a license or permit or report, form, or agreement.
“Veteran” means an individual who has served in the United
States Armed Forces.
“Virtual manufacturer” means an entity that contracts for the
manufacture of a drug or device for which the entity:
Owns the New Drug Application or Abbreviated New
Drug Application number, as defined by the FDA, for a
drug;
Owns the Unique Device Identification number, as
defined by the FDA, for a prescription device;
Is not involved in the physical manufacture of the drug or
device; and
Contracts with an Arizona-permitted manufacturing
entity for the physical manufacture of the drug or device;
or
If the contracted manufacturing entity is in a location not
included in the definition at A.R.S. 32-1901 of other
jurisdiction, the virtual manufacturer ensures the facility
is inspected every time the virtual manufacturer submits
an initial or renewal application and determined to com-
ply with current good manufacturing practices as defined
by the federal act and the official compendium.
Virtual manufacturer includes an entity that may be iden-
tified as an own-label distributor, which contracts with a
manufacturer to produce a drug or device and with
another entity to package and label the drug or device,
which is then sold under the distributor’s name or another
name.
“Virtual wholesaler” means an entity that engages in the
wholesale distribution of a drug or device in, into, or out of
Arizona but does not take physical possession of the drug or
device. A virtual wholesaler distributes a drug or device only
from a Board-permitted facility to:
A Board-permitted pharmacy, drug manufacturer, full-
service drug wholesaler, or non-prescription drug whole-
saler; or
A medical practitioner licensed under A.R.S. Title 32;
and
Virtual wholesaler includes an entity that may be identi-
fied as a broker that buys and sells goods for others or a
person that facilitates distribution of a drug, chemical, or
device regulated by the Board.
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 11
“Wholesale distribution” means distribution of a drug to a per-
son other than a consumer or patient, but does not include:
Selling, purchasing, or trading a drug or offering to sell,
purchase, or trade a drug for emergency medical reasons.
For purposes of this Section, “emergency medical rea-
sons” includes transferring a prescription drug by a com-
munity or hospital pharmacy to another community or
hospital pharmacy to alleviate a temporary shortage;
Selling, purchasing, or trading a drug, offering to sell,
purchase, or trade a drug, or dispensing a drug as speci-
fied in a prescription;
Distributing a drug sample by a manufacturers’ or distrib-
utors’ representative; or
Selling, purchasing, or trading blood or blood compo-
nents intended for transfusion.
“Wholesale distributor” means any person engaged in whole-
sale distribution of drugs, including: manufacturers; repackers;
own-label distributors; private-label distributors; jobbers; bro-
kers; warehouses, including manufacturers’ and distributors’
warehouses, chain drug warehouses, and wholesale drug ware-
houses; independent wholesale drug traders; and retail phar-
macies that conduct wholesale distributions in the amount of at
least 5% of gross sales.
Historical Note
Adopted effective August 24, 1992 (Supp. 92-2).
Amended effective December 18, 1992 (Supp. 92-4).
Amended effective November 1, 1993 (Supp. 93-4).
Amended effective April 1, 1995; filed with the Secretary
of State January 31, 1995 (Supp. 95-1). Amended effec-
tive April 5, 1996 (Supp. 96-2). Amended effective July
8, 1997; amended effective August 5, 1997 (Supp. 97-3).
Amended effective January 12, 1998 (Supp. 98-1).
Amended effective July 7, 1998 (Supp. 98-3). Amended
by final rulemaking at 5 A.A.R. 862, effective March 3,
1999 (Supp. 99-1). Amended by final rulemaking at 5
A.A.R. 4441, effective November 2, 1999 (Supp. 99-4).
Amended by final rulemaking at 6 A.A.R. 4589, effective
November 14, 2000 (Supp. 00-4). Amended by final
rulemaking at 7 A.A.R. 646, effective January 11, 2001
(Supp. 01-1). Amended by final rulemaking at 8 A.A.R.
409 and 8 A.A.R. 646, effective January 10, 2002 (Supp.
02-1). Amended by final rulemaking at 8 A.A.R. 416,
effective January 10, 2002 (Supp. 02-1). Amended by
final rulemaking at 8 A.A.R. 1256, effective March 7,
2002 (Supp. 02-1). Amended by final rulemaking at 8
A.A.R. 4052, effective November 9, 2002 (Supp. 02-3).
Amended by final rulemaking at 8 A.A.R. 4898 and 8
A.A.R. 4902, effective January 5, 2003 (Supp. 02-4).
Amended by final rulemaking at 9 A.A.R. 1064, effective
May 4, 2003 (Supp. 03-1). Amended by final rulemaking
at 9 A.A.R. 5030, effective January 3, 2004 (Supp. 03-4).
Amended by final rulemaking at 10 A.A.R. 1192, effec-
tive May 1, 2004 (Supp. 04-1). Amended by final
rulemaking at 10 A.A.R. 3391, effective October 2, 2004
(Supp. 04-3). Amended by final rulemaking at 10 A.A.R.
3967, effective November 13, 2004 (Supp. 04-3).
Amended by final rulemaking at 10 A.A.R. 4356, effec-
tive December 4, 2004 (Supp. 04-4). Amended by final
rulemaking at 11 A.A.R. 2258, effective August 6, 2005
(Supp. 05-2). Amended by final rulemaking at 12 A.A.R.
3032, effective October 1, 2006 (Supp. 06-3). Amended
by final rulemaking at 12 A.A.R. 3981, effective Decem-
ber 4, 2006 (Supp. 06-4). Amended by final rulemaking
at 13 A.A.R. 520, effective April 7, 2007 (Supp. 07-1).
Amended by final rulemaking at 13 A.A.R. 440, effective
April 7, 2007 (Supp. 07-1). Amended by final rulemaking
at 13 A.A.R. 616, effective April 7, 2007 (Supp. 07-1).
Amended by final rulemaking at 13 A.A.R. 3477, effec-
tive December 1, 2007 (Supp. 07-4). Amended by final
rulemaking at 14 A.A.R. 3405, effective October 4, 2008;
amended by final rulemaking at 14 A.A.R. 3410, effec-
tive October 4, 2008 (Supp. 08-3). Amended by final
rulemaking at 14 A.A.R. 4400, effective January 3, 2009;
amended by final rulemaking at 14 A.A.R. 4320, effec-
tive January 3, 2009 (Supp. 08-4). Amended by final
rulemaking at 18 A.A.R. 2603, effective December 2,
2012 (Supp. 12-4). Amended by final rulemaking at 18
A.A.R. 2609, effective December 2, 2012 (Supp. 12-4).
Amended by final rulemaking at 19 A.A.R. 2894, effec-
tive November 10, 2013 (Supp. 13-3). Amended by final
rulemaking at 20 A.A.R. 1364, effective August 2, 2014
(Supp. 14-2). Amended by exempt rulemaking under
Laws 2016, Ch. 284, § 3 at 22 A.A.R. 2606, effective
August 31, 2016 (Supp. 16-3). Amended by final
rulemaking at 25 A.A.R. 1015, effective June 1, 2019
(Supp. 19-2). Amended by final rulemaking at 26 A.A.R.
223, effective March 14, 2020 (Supp. 20-1).
R4-23-111. Notice of Hearing
A. Except as provided in A.R.S. § 32-1928(B), the Board shall
revoke, suspend, place on probation, or fine a licensee or per-
mittee only after:
1. Notice is served under this Section, and
2. A hearing is conducted under R4-23-122.
B. The Board shall give notice of hearing to a party at least 30
days before the date set for the hearing in the manner
described in R4-23-115(E) and (F). The notice shall include:
1. A statement of the date, time, place, and nature of the
hearing;
2. A statement of the legal authority and jurisdiction for the
hearing;
3. A reference to the particular section or sections of statute
and rule involved; and
4. A statement of the violation or issue asserted by the
Board.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-112. Ex Parte Communications
A party shall not communicate, either directly or indirectly, with a
Board member about any substantive issue in a pending matter
unless:
1. All parties are present;
2. It is during a scheduled proceeding, where an absent
party fails to appear after proper notice; or
3. It is by written motion with copies to all parties.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-113. Motions
A. Purpose. A party requesting a ruling from the Board shall file a
motion. Motions may be made for rulings such as:
1. Continuing or expediting a hearing under R4-23-116;
2. Vacating a hearing under R4-23-117;
3. Scheduling a prehearing conference under R4-23-118;
4. Quashing a subpoena under R4-23-119;
5. Requesting telephonic testimony under R4-23-120; and
6. Reconsidering a previous order under R4-23-121.
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 12 Supp. 20-1 March 31, 2020
B. Form. Unless made during a prehearing conference or hearing,
motions shall be made in writing and shall conform to the
requirements of R4-23-115. All motions, whether written or
oral, shall state the factual and legal grounds supporting the
motion, and the requested action.
C. Time limits. Absent good cause, or unless otherwise provided
by law or these rules, written motions shall be filed with the
Board office at least 15 days before the hearing. A party
demonstrates good cause by showing that the grounds for the
motion could not have been known in time, using reasonable
diligence and:
1. A ruling on the motion will further administrative conve-
nience, expedition or economy; or
2. A ruling on the motion will avoid undue prejudice to any
party.
D. Response to motion. A party shall file a written response stat-
ing any objection to the motion within five days of service, or
as directed by the Board.
E. Oral argument. A party may request oral argument when filing
a motion or response. If necessary to develop a complete
record, the Board shall grant oral argument.
F. Rulings. Rulings on motions, other than those made during a
prehearing conference or the hearing, shall be in writing and
served on all parties.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-114. Computing Time
In computing any time period, the Board shall exclude the day from
which the designated time period begins to run. The Board shall
include the last day of the period unless it falls on a Saturday, Sun-
day, or legal holiday. When the time period is 10 days or less, the
Board shall exclude Saturdays, Sundays, and legal holidays.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-115. Filing Documents
A. Docket. The Board shall open a docket for each hearing. All
documents filed in a matter with the Board shall be date
stamped on the day received by the Board office and entered in
the docket.
B. Definition. “Documents” include papers such as complaints,
answers, motions, responses, notices, and briefs.
C. Form. A party shall state on the document the name and
address of each party served and how service was made under
subsection (E). A document shall contain the Board caption
and the Board’s docket number.
D. Signature. A document filed with the Board shall be signed by
the party or the party’s attorney. A signature constitutes a certi-
fication that the signer has read the document, has a good faith
basis for submission of the document, and that it is not filed
for the purpose of delay or harassment.
E. Filing and service. A copy of a document filed with the Board
shall be served on all parties. Filing with the Board office and
service shall be completed by personal delivery; first-class,
certified, or express mail; or facsimile.
F. Date of filing and service. A document is filed with the Board
on the date it is received by the Board office, as established by
the Board office’s date stamp on the face of the document. A
copy of a document is served on a party as follows:
1. On the date it is personally served,
2. Five days after it is mailed by first-class or express mail,
3. On the date of the return receipt if it is mailed by certified
mail, or
4. On the date indicated on the facsimile transmission.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-116. Continuing or Expediting a Hearing; Reconven-
ing a Hearing
A. Continuing or expediting a hearing. When ruling on a motion
to continue or expedite, the Board shall consider such factors
as:
1. The time remaining between the filing of the motion and
the hearing date;
2. The position of other parties;
3. The reasons for expediting the hearing or for the unavail-
ability of the party, representative, or counsel on the date
of the scheduled hearing;
4. Whether testimony of an unavailable witness can be
taken telephonically or by deposition; and
5. The status of settlement negotiations.
B. Reconvening a hearing. The Board may recess a hearing and
reconvene at a future date by a verbal ruling.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-117. Vacating a Hearing
The Board shall vacate a calendared hearing and return the matter
to the Board office for further action, if:
1. The parties agree to vacate the hearing;
2. The Board dismisses the matter;
3. The non-Board party withdraws the appeal; or
4. Facts demonstrate to the Board that it is appropriate to
vacate the hearing for the purpose of informal disposi-
tion, or if the action will further administrative conve-
nience, expedition, and economy and does not conflict
with law or cause undue prejudice to any party.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-118. Prehearing Conference
A. Procedure. The Board may hold a prehearing conference. The
conference may be held telephonically. The Board may issue a
prehearing order outlining the issues to be discussed.
B. Record. The Board may record any agreements reached during
a prehearing conference by electronic or mechanical means, or
memorialize them in an order.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-119. Subpoenas
A. Form. A party shall request a subpoena in writing from the
Board and shall include:
1. The caption and docket number of the matter;
2. A list or description of any documents sought;
3. The full name and home or business address of the custo-
dian of the documents sought or all persons to be subpoe-
naed;
4. The date, time, and place to appear or to produce docu-
ments pursuant to the subpoena; and
5. The name, address, and telephone number of the party, or
the party’s attorney, requesting the subpoena.
B. The Board may require a brief statement of the relevance of
testimony or documents.
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 13
C. Service of subpoena. Any person who is not a party and is at
least 18 years of age may serve a subpoena. The person shall
serve the subpoena by delivering a copy to the person to be
served. The person serving the subpoena shall provide proof of
service by filing with the Board office a certified statement of
the date and manner of service and the names of the persons
served.
D. Objection to subpoena. A party, or the person served with a
subpoena who objects to the subpoena, or any portion of it,
may file an objection with the Board. The objection shall be
filed within five days after service of the subpoena, or at the
outset of the hearing if the subpoena is served fewer than five
days before the hearing.
E. Quashing, modifying subpoenas. The Board shall quash or
modify a subpoena if:
1. It is unreasonable or oppressive, or
2. The desired testimony or evidence may be obtained by an
alternative method.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-120. Telephonic Testimony
The Board may grant a motion for telephonic testimony if:
1. Personal attendance by a party or witness at the hearing
will present an undue hardship for the party or witness;
2. Telephonic testimony will not cause undue prejudice to
any party; and
3. The proponent of the telephonic testimony pays for any
cost of obtaining the testimony telephonically.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-121. Rights and Responsibilities of Parties
A. Generally. A party may present testimony and documentary
evidence and argument with respect to the contested issue and
may examine and cross-examine witnesses.
B. Preparation. A party shall have all witnesses, documents, and
exhibits available on the date of the hearing.
C. Exhibits. A party shall provide a copy of each exhibit to all
other parties at the time the exhibit is offered to the Board,
unless the exhibit was previously provided to all other parties.
D. Responding to orders. A party shall comply with an order
issued by the Board concerning the conduct of a hearing.
Unless an objection is made orally during a pre-hearing con-
ference or hearing, a party shall file a motion requesting the
Board to reconsider the order.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-122. Conduct of Hearing
A. Public access. Unless otherwise provided by law, all hearings
are open to the public and may be conducted in an informal
manner as prescribed in A.R.S. § 41-1092 et seq.
B. Opening. The Board shall begin the hearing by reading the
caption, stating the nature and scope of the hearing, and identi-
fying the parties, counsel, and witnesses for the record.
C. Stipulations. The Board shall enter into the record any stipula-
tion, settlement agreement, or consent order entered into by
any of the parties before or during the hearing.
D. Opening statements. The party with the burden of proof may
make an opening statement at the beginning of a hearing. All
other parties may make statements in a sequence determined
by the Board.
E. Order of presentation. After opening statements, the party with
the burden of proof shall begin the presentation of evidence,
unless the parties agree otherwise or the Board determines that
requiring another party to proceed first would be more expedi-
tious or appropriate, and would not prejudice any other party.
Copies of documentary evidence may be received in the dis-
cretion of the Board. Upon request, parties shall be given an
opportunity to compare the copy with the original.
F. Examination. A party shall conduct direct and cross examina-
tion of witnesses in the order and manner determined by the
Board to expedite and ensure a fair hearing. The Board shall
make rulings necessary to prevent argumentative, repetitive, or
irrelevant questioning and to expedite the examination to the
extent consistent with the disclosure of all relevant testimony
and information. The Board may take notice of judicially cog-
nizable facts. In addition, the Board may take notice of gener-
ally recognized technical or scientific facts within the Board’s
or its staff’s specialized knowledge. A party shall be notified
either before or during the hearing or by reference in prelimi-
nary reports of the material the Board notices. The Board may
use the Board’s or its staff’s experience, technical competence,
and specialized knowledge in the evaluation of the evidence.
G. Closing argument. When all evidence has been received, par-
ties shall have the opportunity to present closing oral argu-
ment, in a sequence determined by the Board. The Board may
permit or require closing oral argument to be supplemented by
written memoranda. The Board may permit or require written
memoranda to be submitted simultaneously or sequentially,
within time periods the Board may prescribe.
H. Conclusion of hearing. Unless otherwise provided by the
Board, the hearing is concluded upon the submission of all
evidence, the making of final argument, and the issuing of a
final decision or order of the Board.
I. Decisions and orders. Unless otherwise provided by law, any
final decisions or order adverse to a party in a hearing shall be
in writing or stated in the record. Any final decision shall
include findings of fact and conclusions of law, separately
stated. Findings of fact shall be accompanied by a concise and
explicit statement of the underlying facts supporting the find-
ings. Unless otherwise provided by law, each party shall be
notified either personally or by mail to the party’s last known
address of record of any decision or order. Upon request, a
copy of the decision or order shall be delivered or mailed to
each party and to each party’s attorney of record.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-123. Failure of Party to Appear for Hearing
If a party fails to appear at a hearing, the Board may proceed with
the presentation of the evidence of the appearing party, or vacate
the hearing and return the matter to the Board office for any further
action.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-124. Witnesses; Exclusion from Hearing
All witnesses at the hearing shall testify under oath or affirmation.
At the request of a party, or at the discretion of the Board, the Board
may exclude witnesses who are not parties from the hearing room
so that they cannot hear the testimony of other witnesses.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 14 Supp. 20-1 March 31, 2020
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-125. Proof
A. Standard of proof. Unless otherwise provided by law, the stan-
dard of proof is a preponderance of the evidence.
B. Burden of proof. Unless otherwise provided by law:
1. The party asserting a claim, right, or entitlement has the
burden of proof;
2. A party asserting an affirmative defense has the burden of
establishing the affirmative defense; and
3. The proponent of a motion shall establish the grounds to
support the motion.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-126. Disruptions
A person shall not interfere with access to or from the hearing
room, or interfere, or threaten interference with the hearing. If a
person interferes, threatens interference, or disrupts the hearing, the
Board may order the disruptive person to leave or be removed.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-127. Hearing Record
A. Maintenance. The Board shall maintain the official administra-
tive record of a matter.
B. Transfer of record. Any party requesting a copy of the admin-
istrative record or any portion of the administrative record
shall make a request to the Board office and shall pay the rea-
sonable costs of duplication.
C. Release of exhibits. Exhibits shall be released:
1. Upon the order of a court of competent jurisdiction; or
2. Upon motion of the party who submitted the exhibits if
the time for judicial appeal has expired and no appeal is
pending.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-128. Rehearing or Review and Appeal of Decision
A. The Board shall provide for a rehearing and review of it deci-
sions under A.R.S. Title 41, Chapter 6, Article 10, and this
Section. For purposes of these rules, the terms “contested
case” and “party” are defined in A.R.S. § 41-1001.
B. A party to a contested case shall exhaust the party’s adminis-
trative remedies by filing a motion for rehearing or review
within 30 days after the service of the Board decision that is
subject to rehearing or review in order to be eligible for judi-
cial review under A.R.S. Title 12, Chapter 7, Article 6. The
Board shall notify a party in its decision, that is subject to
rehearing or review, that the party may file a motion for
rehearing or review, and that failure to file a motion for rehear-
ing or review within 30 days after service of the decision has
the effect of prohibiting the party from seeking judicial review
of the Board’s decision.
C. A party may amend a motion for rehearing or review at any
time before the Board rules on the motion.
D. The Board may grant a rehearing or review for any of the fol-
lowing reasons materially affecting a party’s rights:
1. Irregularity in the proceedings of the Board, or any order
or abuse of discretion, that deprived the moving party of a
fair hearing;
2. Misconduct of the Board, its staff, its hearing officer, or
the prevailing party;
3. Accident or surprise that could not have been prevented
by ordinary prudence;
4. Newly discovered material evidence that could not, with
reasonable diligence, have been discovered and produced
at the hearing;
5. Excessive or insufficient penalty;
6. Error in the admission or rejection of evidence or other
errors of law occurring at the hearing or during the prog-
ress of the proceedings;
7. That the Board’s decision is a result of passion or preju-
dice; or
8. That the findings of fact or decision is not justified by the
evidence or is contrary to law.
E. The Board may affirm or modify a decision or grant a rehear-
ing to all or any of the parties on all or part of the issues for
any of the reasons in subsection (D). An order modifying a
decision or granting a rehearing shall specify with particularity
the grounds for the order.
F. If a motion for rehearing or review is based upon affidavits,
they shall be served with the motion. An opposing party may,
within 15 days after service, serve opposing affidavits. The
Board may extend this period for a maximum of 20 days, for
good cause as described in subsection (I).
G. Not later than 10 days after the date of a decision, after giving
parties notice and an opportunity to be heard, the Board may
grant a rehearing or review on its own initiative for any reason
for which it might have granted relief on the motion of a party.
The Board may grant a motion for rehearing or review, timely
served, for a reason not stated in the motion.
H. If a rehearing is granted, the Board shall hold the rehearing
within 60 days after the order granting the rehearing is issued.
I. The Board may extend all time limits listed in this Section
upon a showing of good cause. A party demonstrates good
cause by showing that the grounds for the party’s motion or
other action could not have been known in time, using reason-
able diligence, and a ruling on the motion will:
1. Further administrative convenience, expedition, or econ-
omy; or
2. Avoid undue prejudice to any party.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
R4-23-129. Notice of Judicial Appeal; Transmitting the
Transcript
A. Notification to the Board office. Within 10 days of filing a
complaint for judicial review of a final administrative decision
of the Board, the party shall file a copy of the complaint with
the Board office. The Board office shall then transmit the
administrative record to the Superior Court.
B. Transcript. A party requesting a transcript shall arrange for
transcription at the party’s expense. The Board office shall
make a copy of the audio taped record available to the tran-
scriber. The party arranging for transcription shall deliver the
transcript, certified by the transcriber under oath to be a true
and accurate transcription of the audio taped record, to the
Board office, together with one unbound copy.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1132, effective May 1, 2004 (Supp. 04-1).
ARTICLE 2. PHARMACIST LICENSURE
R4-23-201. General
A. License required. Before practicing as a pharmacist in Ari-
zona, a person shall possess a valid pharmacist license issued
by the Board. There is no temporary licensure.
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 15
B. Methods of licensure. Licensure as a pharmacist shall be
either:
1. By practical examination, using paper and pencil written
testing, computer adaptive testing, or other Board-
approved testing method; or
2. By reciprocity.
C. Practicing pharmacist holding a delinquent license. Before the
Board reinstates an Arizona pharmacist license, a pharmacist,
whose Arizona pharmacist license is delinquent for five or
more years and who is practicing pharmacy outside the
Board’s jurisdiction with a pharmacist license issued by
another jurisdiction, shall:
1. Pass the MPJE or other Board-approved jurisprudence
examination,
2. Pay all delinquent annual renewal fees, and
3. Pay penalty fees.
D. Non-practicing pharmacist holding a delinquent license.
Before the Board reinstates an Arizona pharmacist license, a
pharmacist, whose Arizona pharmacist license is delinquent
for five or more years and who did not practice pharmacy
within the last 12 months before seeking reinstatement, shall:
1. Complete the requirements in subsection (C), and
2. Appear before the Board to furnish satisfactory proof of
fitness to be licensed as a pharmacist.
E. Verification of license. A pharmacy permittee or pharmacist-
in-charge shall not permit a person to practice as a pharmacist
until the pharmacy permittee or pharmacist-in-charge verifies
that the person is currently licensed by the Board as a pharma-
cist.
Historical Note
Former Rules 2.1100, 2.1310, 2.1320, and 2.1400.
Amended effective August 23, 1978 (Supp. 78-4).
Amended by deleting subsection (E) effective April 20,
1982 (Supp. 82-2). Amended subsections (C) and (D)
effective August 12, 1988 (Supp. 88-3). Amended effec-
tive February 8, 1991 (Supp. 91-1). Amended effective
January 12, 1998 (Supp. 98-1). Amended by final
rulemaking at 10 A.A.R. 4356, effective December 4,
2004 (Supp. 04-4). Amended by final rulemaking at 19
A.A.R. 2911, effective November 10, 2013 (Supp. 13-3).
R4-23-202. Licensure by Examination
A. Eligibility. To be eligible for licensure as a pharmacist by
examination, a person shall:
1. Have a degree in pharmacy from a school or college of
pharmacy approved by the Board as specified in A.R.S. §
32-1935, and whose professional degree program, at the
time the person graduates, is accredited by the Accredita-
tion Council for Pharmacy Education; or
2. Qualify under the requirements of A.R.S. § 32-1922(D);
and
3. Complete no fewer than 1500 hours of intern training as
specified in R4-23-303.
B. Application.
1. An applicant for licensure by examination shall:
a. Submit a completed application for licensure by
examination electronically or manually on a form
furnished by the Board, and
b. Submit with the application form:
i. The documents specified in the application
form, and
ii. The application fee specified in R4-23-205.
2. The Board office shall deem an application form received
on the date the Board office electronically or manually
date-stamps the form.
3. An applicant for licensure by examination shall register
for NAPLEX and MPJE through NABP’s registration
process.
4. The Board shall deem an application for licensure by
examination invalid after 12 months from the date the
application is received. An applicant whose application
form is invalid and who wishes to continue licensure pro-
cedures, shall submit a new application form and fee as
specified under subsection (B)(1).
C. Passing grade; notification; re-examination.
1. To pass the required examinations, an applicant shall
obtain a score of at least 75 on both the NAPLEX and
MPJE.
2. The Board office shall:
a. Retrieve an applicant’s NAPLEX and MPJE score
from the NABP database no later than two weeks
after the applicant’s examination date, and
b. Provide written notice by mail to an applicant who
fails the NAPLEX or MPJE no later than seven days
after the Board office retrieves the applicant’s score
from NABP.
3. An applicant who fails the NAPLEX or MPJE may regis-
ter with the NABP to retake the examination within the
12-month period defined in subsection (B)(4). An appli-
cant who fails the NAPLEX or MPJE three times shall
petition the Board as specified in R4-23-401 for Board
approval before retaking the examination.
4. For the purpose of licensure by examination, the Board
office shall deem a passing score on the NAPLEX or
MPJE invalid after 24 months from the applicant’s exam-
ination date. An applicant who fails to complete the licen-
sure process within the 24-month period, and who wishes
to continue licensure procedures, shall retake the exam-
ination(s).
D. NAPLEX score transfer.
1. The Board office shall deem a score transfer received on
the date the NABP transmits the applicant’s official score
transfer report to the Board office.
2. An applicant who receives a passing score on the
NAPLEX taken in another jurisdiction shall, within 12
months from the date the Board office receives the appli-
cant’s official NABP score transfer report from the
NABP, make application for licensure according to sub-
section (B). After 12 months, an applicant may reapply
for licensure in this state under the provisions of subsec-
tion (B) or R4-23-203(B).
3. An applicant who takes the NAPLEX in another jurisdic-
tion and fails the examination may apply for licensure in
this state under the provisions of subsection (B).
E. Licensure.
1. The Board office shall issue a certificate of licensure and
a wall license to a successful applicant upon receipt of:
a. The initial licensure fee specified in R4-23-205, and
b. The wall license fee specified in R4-23-205.
2. A licensee shall maintain the certificate of licensure in the
practice site for inspection by the Board or its designee or
review by the public.
F. Time frames for licensure by examination.
1. The Board office shall complete an administrative com-
pleteness review within 60 days from the date the appli-
cation form is received.
a. The Board office shall issue a written notice of
administrative completeness to the applicant if no
deficiencies are found in the application form.
b. If the application form is incomplete, the Board
office shall provide the applicant with a written
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 16 Supp. 20-1 March 31, 2020
notice that includes a comprehensive list of the miss-
ing information. The 60-day time frame for the
Board office to finish the administrative complete-
ness review is suspended from the date the notice of
incompleteness is served until the applicant provides
the Board office with all missing information.
c. If the Board office does not provide the applicant
with written notice regarding administrative com-
pleteness, the application form shall be deemed
complete 60 days after receipt by the Board office.
2. An applicant with an incomplete application form shall
submit all of the missing information within 90 days of
service of the notice of incompleteness.
a. If an applicant cannot submit all missing informa-
tion within 90 days of service of the notice of incom-
pleteness, the applicant may send a written request
for an extension to the Board office postmarked or
delivered no later than 90 days from service of the
notice of incompleteness.
b. The written request for an extension shall document
the reasons the applicant is unable to meet the 90-
day deadline.
c. The Board office shall review the request for an
extension of the 90-day deadline and grant the
request if the Board office determines that an exten-
sion of the deadline will enable the applicant to
assemble and submit the missing information. An
extension shall be for no more than 30 days. The
Board office shall notify the applicant in writing of
its decision to grant or deny the request for an exten-
sion.
3. If an applicant fails to submit a complete application form
within the time allowed, the Board office shall close the
applicant’s file. An applicant whose file is closed and
who later wishes to obtain a license shall apply again
according to subsection (B).
4. The Board office shall complete a substantive review of
the applicant’s qualifications in no more than 120 days
from the date on which the administrative completeness
review of an application form is complete.
a. If an applicant is found to be ineligible for licensure
by examination, the Board office shall issue a writ-
ten notice of denial to the applicant.
b. If an applicant is found to be eligible to take the
NAPLEX, the Board office shall notify the NABP
that the applicant is eligible to test. The NABP shall
issue the applicant an authorization to test letter.
c. If an applicant is found to be eligible to take the
MPJE, the Board office shall notify the NABP that
the applicant is eligible to test. The NABP shall
issue the applicant an authorization to test letter.
d. The Board office shall deem an applicant’s eligibil-
ity to test invalid after 12 months from the date the
application for licensure by examination is received.
e. If the Board office finds deficiencies during the sub-
stantive review of an application form, the Board
office shall issue a written request to the applicant
for additional documentation.
f. The 120-day time frame for a substantive review of
eligibility to take the NAPLEX or MPJE is sus-
pended from the date of a written request for addi-
tional documentation until the date that all
documentation is received. The applicant shall sub-
mit the additional documentation according to sub-
section (F)(2).
g. If the applicant and the Board office mutually agree
in writing, the 120-day substantive review time
frame may be extended once for no more than 45
days.
5. For the purpose of A.R.S. § 41-1072 et seq., the Board
establishes the following time frames for licensure by
examination.
a. Administrative completeness review time frame: 60
days.
b. Substantive review time frame: 120 days.
c. Overall time frame: 180 days.
G. License renewal.
1. To renew a license, a pharmacist shall submit a com-
pleted license renewal application electronically or manu-
ally on a form furnished by the Board with the biennial
renewal fee specified in R4-23-205.
2. If the biennial renewal fee is not paid by November 1 of
the renewal year specified in A.R.S. § 32-1925, the phar-
macist license is suspended and the licensee shall not
practice as a pharmacist. The licensee shall pay a penalty
as provided in A.R.S. § 32-1925 and R4-23-205 to vacate
the suspension.
3. A licensee shall maintain the renewal certificate of licen-
sure in the practice site for inspection by the Board or its
designee or review by the public.
4. Time frames for license renewals. The Board office shall
follow the time frames established in subsection (F).
Historical Note
Former Rules 2.2100, 2.2200, 2.2300, 2.2400, 2.2500,
2.2600, 2.2700, 2.2800, 2.2910, 2.2920, 2.2930, 2.3000,
2.3010, 2.3100; Amended effective August 23, 1978
(Supp. 78-5). Amended effective June 10, 1981 (Supp.
81-3). Former Section R4-23-202 repealed, new Section
R4-23-202 adopted effective July 24, 1985 (Supp. 85-4).
Amended effective March 13, 1991 (Supp. 91-1).
Amended effective January 12, 1998 (Supp. 98-1).
Amended by final rulemaking at 8 A.A.R. 409 and 8
A.A.R. 646, effective January 10, 2002 (Supp. 02-1).
Amended by final rulemaking at 10 A.A.R. 4356, effec-
tive December 4, 2004 (Supp. 04-4). Amended by final
rulemaking at 12 A.A.R. 4689, effective February 3, 2007
(Supp. 06-4). Amended by final rulemaking at 14 A.A.R.
3605, effective November 8, 2008 (Supp. 08-3).
Amended by final rulemaking at 19 A.A.R. 2911, effec-
tive November 10, 2013 (Supp. 13-3). Amended by final
rulemaking at 25 A.A.R. 1012 and 25 A.A.R. 1015, effec-
tive June 1, 2019 (Supp. 19-2).
R4-23-203. Licensure by Reciprocity
A. Eligibility. A person is eligible for licensure by reciprocity
who:
1. Is licensed as a pharmacist in a jurisdiction that provides
reciprocity to Arizona licensees,
2. Has passed the NABPLEX or NAPLEX with a score of
75 or better or was licensed by examination in another
jurisdiction having essentially the same standards for
licensure as this state at the time the pharmacist was
licensed, and
3. Provides evidence to the Board of having completed the
required secondary and professional education and train-
ing specified in R4-23-202(A).
B. Application.
1. An applicant for licensure by reciprocity shall:
a. Submit a completed application for licensure by rec-
iprocity electronically or manually on a form fur-
nished by the Board, and
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 17
b. Submit with the application form:
i. The documents specified in the application
form, and
ii. The reciprocity fee specified in R4-23-205(B).
2. The Board office shall deem an application form received
on the date the Board office electronically or manually
date-stamps the form.
3. An applicant for licensure by reciprocity shall register for
MPJE through NABP’s registration process.
4. The Board office shall deem an application for licensure
by reciprocity invalid after 12 months from the date the
application is received. An applicant whose application
form is invalid and who wishes to continue licensure pro-
cedures shall submit a new application form and fee spec-
ified in subsection (B)(1).
C. Passing grade; notification; re-examination.
1. To pass the required examination, an applicant shall
obtain a score of at least 75 on the MPJE.
2. The Board office shall:
a. Retrieve an applicant’s MPJE score from the NABP
database no later than two weeks after the appli-
cant’s examination date, and
b. Provide written notice by mail to an applicant who
fails the MPJE no later than seven days after the
Board office retrieves the applicant’s score from
NABP.
3. An applicant who fails the MPJE may register with the
NABP to retake the examination within the 12-month
period specified in subsection (B)(4). An applicant who
fails the MPJE three times shall petition the Board as
specified in R4-23-401 for Board approval before retak-
ing the examination.
4. For the purpose of licensure by reciprocity, the Board
office shall deem a passing score on the MPJE invalid
after 24 months from the applicant’s examination date.
An applicant who fails to complete the licensure process
within the 24-month period, and who wishes to continue
licensure procedures, shall retake the examination.
D. Licensure.
1. The Board office shall issue a certificate of licensure and
a wall license to a successful applicant upon receipt of:
a. The initial licensure fee specified in R4-23-205, and
b. The wall license fee specified in R4-23-205.
2. A licensee shall maintain the certificate of licensure in the
practice site for inspection by the Board or its designee or
review by the public.
E. Time frames for licensure by reciprocity. The Board office
shall follow the time frames established for licensure by exam-
ination in R4-23-202(F).
F. License renewal. License renewal shall be the same as speci-
fied in R4-23-202(G).
Historical Note
Former Rules 2.4100, 2.4200, 2.4310, 2.4320, 2.4330,
2.4340, 2.4350, 2.4360, 2.4400, 2.4510, 2.4520, 2.4522,
2.4523, 2.4530, 2.4540, 2.4550, 2.4560, 2.4610, 2.4620,
and 2.4700; Amended effective August 23, 1978 (Supp.
78-4). Amended subsections (H), (L), (O) through (Q)
effective June 10, 1981 (Supp. 81-3). Former Section R4-
23-203 repealed, new Section R4-23-203 adopted effec-
tive July 24, 1985 (Supp. 85-4). Amended effective
March 13, 1991 (Supp. 91-1). Amended effective January
12, 1998 (Supp. 98-1). Amended effective January 12,
1998 (Supp. 98-1). Amended by final rulemaking at 8
A.A.R. 409 and 8 A.A.R. 646, effective January 10, 2002
(Supp. 02-1). Amended by final rulemaking at 10 A.A.R.
4356, effective December 4, 2004 (Supp. 04-4).
Amended by final rulemaking at 14 A.A.R. 3605, effec-
tive November 8, 2008 (Supp. 08-3). Amended by final
rulemaking at 19 A.A.R. 2911, effective November 10,
2013 (Supp. 13-3). Amended by final rulemaking at 25
A.A.R. 1015, effective June 1, 2019 (Supp. 19-2).
R4-23-204. Continuing Education Requirements
A. Under A.R.S. § 32-1936, continuing professional pharmacy
education is mandatory for all licensees.
1. General continuing education requirement. In accordance
with A.R.S. § 32-1925(F), the Board shall not renew a
license unless the licensee has, during the two years pre-
ceding the application for renewal, participated in 30 con-
tact hours (3.0 CEUs) of continuing education activity
sponsored by an Approved Provider as defined in R4-23-
110.
2. Special continuing education requirement. The Board
shall not renew a license unless:
a. A licensee certified under R4-23-411 to administer
immunizations, vaccines, and emergency medica-
tions has participated in at least two contact hours of
continuing education activity related to administer-
ing immunizations, vaccines, and emergency medi-
cations; and
b. A licensee authorized to dispense controlled sub-
stances has participated in at least three contact
hours of opioid-related, substance use disorder-
related, or addiction-related continuing education
activity.
3. A pharmacist is exempt from the continuing education
requirement in subsections (A)(1) and (2) between the
time of initial licensure and first renewal.
B. Acceptance of continuing education units CEUs. The Board
shall:
1. Accept CEUs for continuing education activities spon-
sored only by an Approved Provider;
2. Accept CEUs accrued only during the two-year period
immediately before licensure renewal;
3. Not allow CEUs accrued in a biennial renewal period to
be carried forward to the succeeding biennial renewal
period;
4. Allow a pharmacist who leads, instructs, or lectures to a
group of health professionals on pharmacy-related topics
in a continuing education activity sponsored by an
Approved Provider to receive CEUs for a presentation by
following the same attendance procedures as any other
attender of the continuing education activity; and
5. Not accept as CEUs the performance of normal teaching
duties within a learning institution by a pharmacist whose
primary responsibility is the education of health profes-
sionals.
C. Continuing education records and reporting CEUs. A pharma-
cist shall:
1. Maintain continuing education records that:
a. Verify the continuing education activities the phar-
macist participated in during the preceding five
years; and
b. Consist of a statement of credit or a certificate issued
by an Approved Provider at the conclusion of a con-
tinuing education activity;
2. At the time of licensure renewal, attest to the number of
CEUs the pharmacist participated in during the renewal
period on the biennial renewal form; and
3. When requested by the Board office, submit proof of con-
tinuing education participation within 20 days of the
request.
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 18 Supp. 20-1 March 31, 2020
D. The Board may revoke, suspend, or place on probation the
license of a pharmacist who fails to comply with continuing
education participation, recording, or reporting requirements
of this Section.
E. A pharmacist who is aggrieved by any decision of the Board or
its administrative staff concerning continuing education units
may request a hearing before the Board.
Historical Note
Adopted effective September 1, 1981 (Supp. 81-5).
Amended effective March 13, 1991 (Supp. 91-1).
Amended by final rulemaking at 8 A.A.R. 409 and 8
A.A.R. 646, effective January 10, 2002 (Supp. 02-1).
Amended by final rulemaking at 26 A.A.R. 223, effective
March 14, 2020 (Supp. 20-1).
R4-23-205. Fees
A. The Board shall collect the full biennial fee for all initial and
renewal license and permit applications listed in subsections
(B) and (C).
1. If a license or permit is issued from November of an odd-
numbered year through October of an even-numbered
year, the licensee or permittee shall renew on or before
November 1 of the next odd-numbered year.
2. If a license or permit is issued from November of an
even-numbered year through October of an odd-num-
bered year, the licensee or permittee shall renew on or
before November 1 of the next even-numbered year.
B. Licensure fees:
1. Pharmacist:
a. Initial licensure: $180.
b. Licensure renewal: $180.
2. Intern. Initial licensure: $50.
3. Pharmacy technician:
a. Initial licensure: $72.
b. Licensure renewal: $72.
4. Temporary license valid for 30 days:
a. Pharmacist: $120.
b. Intern: $50.
c. Pharmacy technician: $50.
C. Vendor permit fees (Resident and nonresident):
1. Pharmacy: $480 biennially (Including hospital, and lim-
ited service).
2. Drug wholesaler or manufacturer:
a. Manufacturer: $1000 biennially.
b. Full-service drug wholesaler: $1000 biennially.
c. Nonprescription drug wholesaler: $500 biennially.
3. Drug packager or repackager: $1000 biennially.
4. Compressed medical gas distributor: $200 biennially.
5. Durable medical equipment and compressed medical gas
supplier: $100 biennially.
6. Third-party logistics provider: $1000 biennially.
7. Automated prescription-dispensing kiosk: $480 bienni-
ally.
D. Pharmacy technician trainee 36-month, non-renewable,
license: $50.
1. If an individual obtained an initial pharmacy technician
trainee license before August 9, 2017, the Board shall
allow the individual to reapply once for a pharmacy tech-
nician trainee license if the individual reapplies before the
initial license expires and pays a reapplication fee of $36;
and
2. If a pharmacy technician trainee’s initial license expires
before August 9, 2017, and the pharmacy technician
trainee does not reapply before August 9, 2017, the Board
shall not allow the former pharmacy technician trainee to
reapply.
E. Reciprocity fee: $300.
F. Application fee: $50.
G. Certificate fees:
1. Certificate of free sale: $200 per certificate.
2. Certificate of good manufacturing practice: $200 per cer-
tificate.
3. Annual inspection fee calculated at the average hourly
rate of a pharmacy inspector multiplied by the duration of
the inspection measured in 10-minute increments or por-
tion of a 10-minute increment.
H. Other fees:
1. Wall license.
a. Pharmacist: $20.
b. Pharmacy or graduate intern: $10.
c. Pharmacy technician: $10.
d. Pharmacy technician trainee: $10.
2. Duplicate of any Board-issued license, registration, cer-
tificate, or permit: $10.
3. Duplicate current renewal license: $10.
4. License, permit, or certificate verification: $15.
I. Fees are not refunded under any circumstances except for the
Board’s failure to comply with its established licensure or per-
mit time frames under R4-23-202 or R4-23-602.
J. Penalty. Renewal applications submitted after the expiration
date are subject to a penalty as provided in A.R.S. §§ 32-1925
and 32-1931.
1. Licensees: A penalty equal to half the licensee’s biennial
licensure renewal fee under subsection (B) and not to
exceed $350.
2. Permittees: A penalty equal to half the permittee’s bien-
nial permit fee under subsection (C) and not to exceed
$350.
Historical Note
Adopted effective July 24, 1985 (Supp. 84-5). Amended
subsection (A) paragraph (1) effective May 20, 1988
(Supp. 88-2). Amended effective August 12, 1988 (Supp.
88-3). Amended effective February 8, 1991 (Supp. 91-1).
Amended effective April 1, 1995; filed with the Secretary
of State January 31, 1995 (Supp. 95-1). Amended effec-
tive January 12, 1998 (Supp. 98-1). Amended by final
rulemaking at 6 A.A.R. 4589, effective November 14,
2000 (Supp. 00-4). Amended by final rulemaking at 8
A.A.R. 409 and 8 A.A.R. 646, effective January 10, 2002
(Supp. 02-1). Amended by final rulemaking at 8 A.A.R.
416, effective January 10, 2002 (Supp. 02-1). Amended
by final rulemaking at 10 A.A.R. 1192, effective May 1,
2004 (Supp. 04-1). Amended by final rulemaking at 12
A.A.R. 3032, effective October 1, 2006 (Supp. 06-3).
Amended by final rulemaking at 15 A.A.R. 173, effective
March 7, 2009 (Supp. 09-1). Amended by final rulemak-
ing at 20 A.A.R. 1364, effective August 2, 2014 (Supp.
14-2). Amended by exempt rulemaking under Laws
2016, Ch. 284, § 3 at 22 A.A.R. 2606, effective August
31, 2016 (Supp. 16-3). Amended by final exempt
rulemaking at 23 A.A.R. 2058, effective August 9, 2017;
amended by final exempt rulemaking with amendments
to subsection (D), at 23 A.A.R. 2383 (Supp. 17-3).
Amended by final rulemaking at 25 A.A.R. 1015, effec-
tive June 1, 2019 (Supp. 19-2). Amended by final
rulemaking at 25 A.A.R. 1012, and 25 A.A.R. 1015,
effective June 1, 2019 (Supp. 19-2). Amended by final
rulemaking at 26 A.A.R. 223, effective March 14, 2020
(Supp. 20-1).
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 19
ARTICLE 3. INTERN TRAINING AND PHARMACY INTERN
PRECEPTORS
R4-23-301. Intern Licensure
A. Licensure as a pharmacy intern or graduate intern is for the
purpose of complementing the individual’s academic or expe-
riential education in preparation for licensure as a pharmacist.
An applicant may request a waiver of intern licensure require-
ments by submitting a written request as specified in R4-23-
401 and appearing in person at a Board meeting.
B. The prerequisites for licensure as a pharmacy intern are:
1. Current enrollment, in good standing, in a Board-
approved college or school of pharmacy; or
2. Graduation from a college or school of pharmacy that is
not approved by the Board; and
3. Proof that the applicant is certified by the Foreign Phar-
macy Graduate Examination Committee (FPGEC); or
4. By order of the Board if the Board determines the appli-
cant needs intern training.
C. If a pharmacy intern licensee stops attending pharmacy school
classes before completing the pharmacy school’s requirements
for graduation, the licensee shall immediately stop practicing
as a pharmacy intern and surrender the pharmacy intern
license to the Board or the Board’s designee no later than 30
days after the date of the last attended class, unless the licensee
petitions the Board as specified in R4-23-401 and receives
Board approval to continue working as a pharmacy intern. A
student re-entering a pharmacy program who wishes to con-
tinue internship training shall reapply for pharmacy intern
licensure.
D. The prerequisites for licensure as a graduate intern are:
1. Graduation from a Board-approved college or school of
pharmacy, and
2. Application for licensure as a pharmacist by examination
or reciprocity, or
3. By order of the Board if the Board determines that the
applicant needs intern training.
E. Experiential training. Intern training shall include the activities
and services encompassed by the term “practice of pharmacy”
as defined in A.R.S. § 32-1901.
F. Out-of-state experiential training. An intern shall receive
credit for intern training received outside this state if the Board
determines that the intern training requirements of the jurisdic-
tion in which the training was received are equal to the mini-
mum requirements for intern training in this state. An
applicant seeking credit for intern training received outside
this state shall furnish a certified copy of the records of intern
training from:
1. The Board of Pharmacy or the intern licensing agency of
the other jurisdiction where the training was received; or
2. In a jurisdiction without an intern licensing agency, the
director of the applicant’s Board-approved college or
school of pharmacy’s experiential training program.
G. Verification of license. A pharmacy permittee or pharmacist-
in-charge shall not permit a person to practice as a pharmacy
or graduate intern until the pharmacy permittee or pharmacist-
in-charge verifies that the person is currently licensed by the
Board as a pharmacy or graduate intern.
H. Intern application.
1. An applicant for licensure as a pharmacy intern or gradu-
ate intern shall:
a. Submit a completed application electronically or
manually on a form furnished by the Board, and
b. Submit with the application form:
i. The documents specified in the application
form,
ii. The initial licensure fee specified in R4-23-
205, and
iii. The wall license fee specified in R4-23-205.
2. The Board office shall deem an application form received
on the date the Board office electronically or manually
date-stamps the form.
I. Licensure.
1. If an applicant is found to be ineligible for intern licen-
sure under statute and rule, the Board office shall issue a
written notice of denial to the applicant.
2. If an applicant is found to be eligible for intern licensure
under statute and rule, the Board office shall issue a cer-
tificate of licensure and a wall license. An applicant who
is assigned a license number and who has been granted
“open” status on the Board’s license verification site may
begin practice as a pharmacy intern or graduate intern
before receiving the certificate of licensure.
3. An applicant who is assigned a license number and who
has a “pending” status on the Board’s license verification
site shall not practice as a pharmacy intern or graduate
intern until the Board office issues a certificate of licen-
sure as specified in subsection (2).
4. A licensee shall maintain the certificate of licensure in the
practice site for inspection by the Board or its designee or
review by the public.
J. Time frames for intern licensure. The Board office shall follow
the time frames established in R4-23-202(F).
K. License renewal.
1. A pharmacy intern whose license expires before the
intern completes the education or training required for
licensure as a pharmacist but fewer than six years after
the issuance of the initial pharmacy intern license may
renew the intern license for a period equal to the differ-
ence between the expiration date of the initial intern
license and six years from the issue date of the initial
intern license by payment of a prorated renewal fee based
on the initial license fee specified in R4-23-205.
2. If a pharmacy intern fails to graduate from a Board-
approved college or school of pharmacy within six years
from the date the Board issues the initial intern license,
the intern is not eligible for relicensure as an intern unless
the intern obtains Board approval as specified in A.R.S. §
32-1923(E) and R4-23-401. To remain in good standing,
an intern who receives Board approval for relicensure
shall pay a prorated renewal fee for the number of months
of licensure approved by the Board based on the initial
license fee specified in R4-23-205 before the license
expiration date.
3. If an intern receives Board approval for relicensure and
does not pay the renewal fee specified in subsection
(K)(2) before the license expiration date, the intern
license is suspended and the licensee shall not practice as
an intern. The licensee shall pay a penalty as provided in
A.R.S. § 32-1925 and R4-23-205 to vacate the suspen-
sion.
L. Notification of training.
1. A pharmacy intern who is employed as an intern outside
the experiential training program of a Board-approved
college or school of pharmacy or a graduate intern shall
notify the Board within 10 days of starting or terminating
training, or changing training site.
2. The director of a Board-approved college or school of
pharmacy’s experiential training program shall provide
the Board an intern training report as specified in R4-23-
304(B)(3).
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 20 Supp. 20-1 March 31, 2020
Historical Note
Former Rules 3.1000, 3.1100, 3.1200, 3.2000, 3.2100,
and 3.2200; Amended effective August 23, 1978 (Supp.
78-4). Amended effective April 20, 1982 (Supp. 82-2).
Amended subsections (A), (F) and (G) effective August
12, 1988 (Supp. 88-3). Amended effective November 1,
1993 (Supp. 93-4). Amended by final rulemaking at 8
A.A.R. 416, effective January 10, 2002 (Supp. 02-1).
Amended by final rulemaking at 10 A.A.R. 4356, effec-
tive December 4, 2004 (Supp. 04-4). Amended by final
rulemaking at 11 A.A.R. 3565, effective November 12,
2005 (Supp. 05-3). Amended by final rulemaking at 12
A.A.R. 3032, effective October 1, 2006 (Supp. 06-3).
Amended by final rulemaking at 14 A.A.R. 3670, effec-
tive November 8, 2008 (Supp. 08-3). Amended by final
rulemaking at 19 A.A.R. 2911, effective November 10,
2013 (Supp. 13-3). Amended by final rulemaking at 25
A.A.R. 1015, effective June 1, 2019 (Supp. 19-2).
R4-23-302. Training Site and Pharmacy Intern Preceptors
A. To receive credit for intern training hours, a pharmacy or grad-
uate intern shall train in a site that:
1. Holds a valid Arizona pharmacy permit; or
2. Is an alternative training site. For purposes of this Sec-
tion, the term alternative training site is a non-pharmacy
training site established and monitored by a Board-
approved college or school of pharmacy or other non-
pharmacy site where pharmacy related activities are per-
formed and where an intern gains experience as specified
in R4-23-301(E).
B. Pharmacy intern preceptor. To be a pharmacy intern preceptor,
a pharmacist shall:
1. Hold a current unrestricted pharmacist license;
2. Have a minimum of one year of experience as an actively
practicing pharmacist before acting as a pharmacy intern
preceptor; and
3. If found guilty of violating any federal or state law relat-
ing to the practice of pharmacy, drug or device distribu-
tion, or recordkeeping or unprofessional conduct, enter
into an agreement satisfactory to the Board that places
restrictions on the pharmacist’s license.
C. Preceptor responsibilities. A pharmacy intern preceptor
assumes the responsibilities of a teacher and mentor in addi-
tion to those of a pharmacist. A preceptor shall thoroughly
review pharmacy policy and procedure with each intern. A
preceptor is responsible for the pharmacy-related actions of an
intern during the specific training period. A preceptor shall
give an intern the opportunity for skill development and pro-
vide an intern with timely and realistic feedback regarding
their progress.
D. If an intern completes more than the number of training hours
specified under R4-23-202(A)(3), the pharmacist acting as the
pharmacy intern preceptor shall report the total number of
training hours to the other jurisdiction.
Historical Note
Former Rules 3.3000, 3.3100, 3.3200, 3.3300, 3.3310,
3.3320, 3.3330, 3.3340, 3.3400, 3.4000, 3.4100, 3.4200,
3.4300, and 3.4400; Amended effective August 9, 1983
(Supp. 83-4). Amended by final rulemaking at 8 A.A.R.
416, effective January 10, 2002 (Supp. 02-1). Amended
by final rulemaking at 14 A.A.R. 3605, effective Novem-
ber 8, 2008 (Supp. 08-3). Amended by final rulemaking
at 25 A.A.R. 1015, effective June 1, 2019 (Supp. 19-2).
R4-23-303. Training Time
A. Training. The minimum hours of internship training required
for licensure by examination shall be 1,500.
1. After enrolling in a Board-approved college or school of
pharmacy as prescribed in R4-23-301(B) and receiving a
Board-issued pharmacy intern license, a pharmacy intern
shall complete all required internship training as part of
the pharmacy intern’s Board-approved college or school
of pharmacy experiential training program.
2. After receiving a Board-issued pharmacy intern license,
an individual who is a graduate of a college or school of
pharmacy that is not approved by the Board shall com-
plete a minimum of 1,500 hours of internship training in a
training site or sites as defined in R4-23-302(A).
3. After receiving a Board-issued graduate intern license, a
graduate intern shall complete the number of internship
training hours required by the Board in a training site or
sites as defined in R4-23-302(A).
B. Start of training and limitation of credit. To receive credit as
internship training, the practical experience shall take place in
a pharmacy or an alternative training site as specified in R4-
23-302(A) and under the supervision of a pharmacy intern pre-
ceptor, except for a non-pharmacy site either as part of a
Board-approved college or school of pharmacy experiential
training program or as approved by the Board or its designee.
The Board shall credit no more than 500 hours internship
training as a pharmacy or graduate intern in an alternative
training site specified in R4-23-302(A)(2).
Historical Note
Former Rules 3.5000 and 3.5200; Amended effective
August 23, 1978 (Supp. 78-4). Amended effective August
9, 1983 (Supp. 83-4). Amended by final rulemaking at 8
A.A.R. 416, effective January 10, 2002 (Supp. 02-1).
Amended by final rulemaking at 18 A.A.R. 2619, effec-
tive December 2, 2012 (Supp. 12-4).
R4-23-304. Reports
A. Change of employment or mailing address. A pharmacy intern
or graduate intern shall notify the Board within ten days of
change of employment or mailing address.
B. Annual reports.
1. A pharmacy intern who is a graduate of a college or
school of pharmacy that is not approved by the Board or
is a graduate intern shall provide the Board annual intern
training reports for the duration of training. The phar-
macy intern shall file an annual intern training report on a
report form provided by the Board by calendar year (Jan-
uary 1st through December 31st). An annual intern train-
ing report shall be received at the Board’s office no later
than 30 days after the end of the calendar year. Any
intern training hours reported to the Board office more
than 30 days after the end of the calendar year in which
the training hours were performed shall not be credited
toward the total intern training hours required for licen-
sure.
2. After graduation and before sitting for the NAPLEX or
MPJE, a pharmacy intern who is a graduate of a Board-
approved college or school of pharmacy shall ensure that
the director of the Board-approved college or school of
pharmacy’s experiential training program provides the
Board an intern training report that includes:
a. The dates and number of training hours experienced,
by training site and total; and
b. The date signed and experiential training program
director’s signature verifying that the pharmacy
intern successfully completed the experiential train-
ing program.
Historical Note
Former Rules 3.6100, 3.6200, 3.6300, and 3.6400;
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 21
Amended effective August 23, 1978 (Supp. 78-4).
Amended by final rulemaking at 8 A.A.R. 416, effective
January 10, 2002 (Supp. 02-1). Amended by final
rulemaking at 10 A.A.R. 4356, effective December 4,
2004 (Supp. 04-4). Amended by final rulemaking at 18
A.A.R. 2619, effective December 2, 2012 (Supp. 12-4).
Amended by final rulemaking at 19 A.A.R. 2911, effec-
tive November 10, 2013 (Supp. 13-3).
R4-23-305. Miscellaneous Intern Training Provisions
To prevent a loss of intern hour credit and before beginning train-
ing, an intern may ask the Board if a training site meets the require-
ments specified in R4-23-301(E) and R4-23-302(A).
Historical Note
Former Rule 3.7000; Amended effective August 23, 1978
(Supp. 78-4). Amended by final rulemaking at 8 A.A.R.
416, effective January 10, 2002 (Supp. 02-1).
ARTICLE 4. PROFESSIONAL PRACTICES
R4-23-401. Time-frames for Board Approvals and Special
Requests
A. To request a Board approval required by this Chapter or a spe-
cial request to deviate from or waive compliance with a
requirement of this Chapter, a person shall send a letter by reg-
ular mail, e-mail, or facsimile to the Board office, detailing the
nature of the approval or special request, including the appli-
cable Arizona Revised Statute or administrative code citation.
This Section does not apply to a request from a person regard-
ing the probation, suspension, or revocation of a license or per-
mit.
B. The Board office shall complete an administrative complete-
ness review within 15 days from the date of receipt of a written
request and immediately open a request file for the applicant.
1. The Board office shall issue a written notice of adminis-
trative completeness to the applicant if no deficiencies are
found in the request.
2. If the request is incomplete, the Board office shall pro-
vide the applicant with a written notice that includes a
comprehensive list of the missing information. The 15-
day time-frame for the Board office to finish the adminis-
trative completeness review is suspended from the date
the notice of incompleteness is served until the applicant
provides the Board office with all missing information.
3. If the Board office does not provide the applicant with
notice regarding administrative completeness, the request
is deemed complete 15 days after receipt by the Board
office.
C. An applicant with an incomplete request shall submit all of the
missing information within 30 days of service of the notice of
incompleteness.
1. If an applicant cannot submit all missing information
within 30 days of service of the notice of incompleteness,
the applicant may send a written request for an extension
to the Board office post-marked or delivered no later than
30 days from service of the notice of incompleteness.
2. The written request for an extension shall document the
reasons the applicant cannot meet the 30-day deadline.
3. The Board office shall review the request for an extension
of the 30-day deadline and grant the request if the Board
office determines that an extension of the deadline will
enable the applicant to assemble and submit the missing
information. An extension shall be for no more than 30
days. The Board office shall notify the applicant in writ-
ing of its decision to grant or deny the request for an
extension. An applicant who requires an additional exten-
sion shall submit an additional written request according
to subsections (C)(1) and (C)(2).
D. If an applicant fails to submit a complete request within the
time allowed, the Board office shall close the applicant’s
request file. An applicant whose request file is closed and who
later wishes to obtain an approval or special request shall
apply again according to subsection (A).
E. From the date on which the administrative completeness
review of a request is finished, the Board shall complete a sub-
stantive review of the applicant’s request in no more than 120
days.
1. The Board shall:
a. Approve the request,
b. Deny the request, or
c. If the Board determines deficiencies exist, request
that the applicant produce additional documentation.
2. If the Board approves or denies, the Board office shall
issue a written approval or denial.
3. If the Board finds deficiencies during the substantive
review of a request, the Board office shall issue a written
request to the applicant for additional documentation.
4. The 120-day time-frame for a substantive review of a
request for approval or special request is suspended from
the date of a written request for additional documentation
until the date of the next Board meeting after all docu-
mentation is received. The applicant shall submit the
additional documentation according to subsection (C).
5. If the applicant and the Board office mutually agree in
writing, the 120-day substantive review time-frame may
be extended once for no more than 30 days.
F. If the applicant fails to submit the additional information
requested within the time allowed, the Board office shall close
the applicant’s request file. An applicant whose request file is
closed and who later wishes to obtain an approval or special
request shall apply again according to subsection (A).
G. For the purpose of A.R.S. § 41-1072 et seq., the Board estab-
lishes the following time-frames for a Board approval required
by this Chapter or a special request to deviate from or waive
compliance with a requirement of this Chapter:
1. Administrative completeness review time-frame: 15
days;
2. Substantive review time-frame: 120 days; and
3. Overall time-frame: 135 days.
Historical Note
Former Rule 4.1000; Former Section R4-23-401
repealed, new Section R4-23-401 adopted effective
August 9, 1983 (Supp. 83-4). Amended effective May 16,
1990 (Supp. 90-2). Repealed effective August 24, 1992
(Supp. 92-3). New Section made by final rulemaking at 9
A.A.R. 3184, effective August 30, 2003 (Supp. 03-3).
R4-23-402. Pharmacist, Graduate Intern, and Pharmacy
Intern
A. A pharmacist or a graduate intern or pharmacy intern under the
supervision of a pharmacist shall perform the following pro-
fessional practices in dispensing a prescription medication
from a prescription order:
1. Receive, reduce to written form, and manually initial oral
prescription orders;
2. Obtain and record the name of the individual who com-
municates an oral prescription order;
3. Obtain, or assume responsibility to obtain, from the
patient, patient’s agent, or medical practitioner and
record, or assume responsibility to record, in the patient’s
profile, the following information:
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 22 Supp. 20-1 March 31, 2020
a. Name, address, telephone number, date of birth (or
age), and gender;
b. Individual history including known diseases and
medical conditions, known drug allergies or drug
reactions, and if available a comprehensive list of
medications currently taken and medical devices
currently used;
4. Record, or assume responsibility to record, in the
patient’s profile, a pharmacist’s, graduate intern’s, or
pharmacy intern’s comments relevant to the patient’s
drug therapy, including other information specific to the
patient or drug;
5. Verify the legality and pharmaceutical feasibility of dis-
pensing a drug based upon:
a. The patient’s allergies,
b. Incompatibilities with medications the patient cur-
rently takes,
c. The patient’s use of unusual quantities of dangerous
drugs or narcotics,
d. A medical practitioner’s signature, and
e. The frequency of refills;
6. Verify that a dosage is within proper limits;
7. Interpret the prescription order, which includes exercising
professional judgment in determining whether to dis-
pense a particular prescription;
8. Compound, mix, combine, or otherwise prepare and
package the prescription medication needed to dispense
individual prescription orders;
9. Prepackage or supervise the prepackaging of drugs by a
pharmacy technician or pharmacy technician trainee
under R4-23-1104. For drugs prepackaged by a pharmacy
technician or pharmacy technician trainee, a pharmacist
shall:
a. Verify the drug to be prepackaged;
b. Verify that the label meets the official compen-
dium’s standards;
c. Check the completed prepackaging procedure and
product; and
d. Manually initial the completed label; or
e. For automated packaging systems, manually initial
the completed label or a written log or initial a com-
puter-stored log;
10. Check prescription order data entry to ensure that the data
input:
a. Is for the correct patient by verifying the patient’s
name, address, telephone number, gender, and date
of birth or age;
b. Is for the correct drug by verifying the drug name,
strength, and dosage form;
c. Communicates the prescriber’s directions precisely
by verifying dose, dosage form, route of administra-
tion, dosing frequency, and quantity; and
d. Is for the correct medical practitioner by verifying
the medical practitioner’s name, address, and tele-
phone number;
11. Except as provided in subsection (A)(12), make a final
accuracy check of the completed prescription label
including verification of medication, accuracy of
patient’s name, consistency with prescription order, and
drug utilization review and initial in handwriting or by
another method approved by the Board or its designee the
finished label;
12. If a technology-assisted verification of product program
is used, make a final accuracy check of the completed
prescription label including accuracy of patient’s name,
consistency with prescription order, and drug utilization
review and initial in handwriting or by another method
approved by the Board or its designee the finished label.
If a technology-assisted verification of product program
is used, verification of product is not required.
13. Record, or assume responsibility to record, a prescription
serial number and date dispensed on the original prescrip-
tion order;
14. Obtain, or assume responsibility to obtain, permission to
refill a prescription order and record, or assume responsi-
bility to record on the original prescription order:
a. Date dispensed,
b. Quantity dispensed, and
c. Name of medical practitioner or medical practi-
tioner’s agent who communicates permission to
refill the prescription order;
15. Reduce to written or printed form, or assume responsibil-
ity to reduce to written or printed form, a new prescrip-
tion order received by:
a. Fax,
b. E-mail, or
c. Other means of communication;
16. Verify, or assume responsibility to verify, that a com-
pleted prescription medication is sold only to the correct
patient, patient’s care-giver, or authorized agent;
17. Record on the original prescription order the name or ini-
tials of the pharmacist, graduate intern, or pharmacy
intern who originally dispenses the prescription order;
and
18. Record on the original prescription order the name or ini-
tials of the pharmacist, graduate intern, or pharmacy
intern who dispenses each refill.
B. Only a pharmacist, graduate intern, or pharmacy intern shall
provide oral consultation about a prescription medication to a
patient or patient’s care-giver in an outpatient setting, includ-
ing a patient discharged from a hospital. The oral consultation
is required whenever the following occurs:
1. The prescription medication has not been previously dis-
pensed to the patient in the same strength or dosage form
or with the same directions;
2. The pharmacist, through the exercise of professional
judgment, determines that oral consultation is warranted;
or
3. The patient or patient’s care-giver requests oral consulta-
tion.
C. Oral consultation shall include:
1. Reviewing the name and strength of a prescription medi-
cation or name of a prescription-only device and the
labeled indication of use for the prescription medication
or prescription-only device;
2. Reviewing the prescription’s directions for use;
3. Reviewing the route of administration; and
4. Providing oral information regarding special instructions
and written information regarding side effects, procedure
for missed doses, or storage requirements.
D. When, in the professional judgment of the pharmacist or grad-
uate intern or pharmacy intern under the supervision of a phar-
macist, or when circumstance precludes it, oral consultation
may be omitted if the pharmacist, graduate intern, or pharmacy
intern:
1. Personally provides written information to the patient or
patient’s care-giver that summarizes the information that
would normally be orally communicated;
2. Documents, or assumes responsibility to document, both
the circumstance and reason for not providing oral con-
sultation by a method approved by the Board or its desig-
nee; and
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 23
3. Offers the patient or patient’s care-giver the opportunity
to communicate with a pharmacist, graduate intern, or
pharmacy intern at a later time and provides a method for
the patient or patient’s care-giver to contact a pharmacist,
graduate intern, or pharmacy intern at the pharmacy.
E. The pharmacist or graduate intern or pharmacy intern under
the supervision of a pharmacist, through the exercise of pro-
fessional judgment, may provide oral consultation that
includes:
1. Common severe adverse effects, interactions, or thera-
peutic contraindications, and the action required if they
occur;
2. Techniques of self-monitoring drug therapy;
3. The duration of the drug therapy; and
4. Prescription refill information.
F. Nothing in subsection (B) requires a pharmacist, graduate
intern, or pharmacy intern to provide oral consultation if a
patient or patient’s care-giver refuses the consultation.
G. Using a method approved by the Board or its designee, a phar-
macist, graduate intern, or pharmacy intern shall document, or
assume responsibility to document, that oral consultation is or
is not provided.
H. Oral consultation documentation. When oral consultation is
required as specified in subsection (B), a pharmacist, graduate
intern, or pharmacy intern shall:
1. Document, or assume responsibility to document, that
oral consultation is provided; or
2. When a patient refuses oral consultation or a person other
than the patient or patient’s care-giver picks up a pre-
scription and oral consultation is not provided, document,
or assume responsibility to document, that oral consulta-
tion is not provided; or
3. When a pharmacist, graduate intern, or pharmacy intern
determines to omit oral consultation under subsection (D)
and oral consultation is not provided, document, or
assume responsibility to document, both the circumstance
and reason that oral consultation is not provided; and
4. Document, or assume responsibility to document, the
name, initials, or identification code of the pharmacist,
graduate intern, or pharmacy intern who did or did not
provide oral consultation.
I. When a prescription is delivered to the patient or patient’s
care-giver outside the immediate area of a pharmacy and a
pharmacist is not present, the prescription shall be accompa-
nied by written or printed patient medication information that,
in addition to the requirements in subsection (C), includes:
1. Approved use for the prescription medication;
2. Possible adverse reactions;
3. Drug-drug, food-drug, or disease-drug interactions;
4. Missed dose information; and
5. Telephone number of the dispensing pharmacy or another
method approved by the Board or its designee that allows
a patient or patient’s care-giver to consult with a pharma-
cist.
J. A prescription medication or prescription-only device, deliv-
ered to a patient at a location where a licensed health care pro-
fessional is responsible for administering the prescription
medication to the patient, is exempt from the requirement of
subsection (C).
K. A pharmacist, graduate intern, or pharmacy intern shall wear a
badge indicating name and title while on duty.
L. Nothing in this Section prevents a hospital pharmacist from
accepting a prescription order according to rules pertaining
specifically to hospital pharmacies.
Historical Note
Former Rule 4.1100; Amended effective August 10, 1978
(Supp. 78-4). Amended effective August 9, 1983 (Supp.
83-4). Amended effective May 16, 1990 (Supp. 90-2).
Amended effective July 7, 1998 (Supp. 98-3). Amended
by final rulemaking at 6 A.A.R. 4656, effective Novem-
ber 14, 2000 (Supp. 00-4). Amended by final rulemaking
at 9 A.A.R. 5030, effective January 3, 2004 (Supp. 03-4).
Amended by final rulemaking at 10 A.A.R. 1192, effec-
tive May 1, 2004 (Supp. 04-1). Amended by final
rulemaking at 11 A.A.R. 2258, effective August 6, 2005
(Supp. 05-2). Amended by final rulemaking at 12 A.A.R.
274, effective March 11, 2006 (Supp. 06-1). Amended by
final rulemaking at 12 A.A.R. 4691, effective February 3,
2007 (Supp. 06-4). Amended by final rulemaking at 23
A.A.R. 3257, effective January 8, 2018 (Supp. 17-4).
R4-23-403. Repealed
Historical Note
Former Rule 4.1200; Amended effective August 10, 1978
(Supp. 78-4). Amended effective March 28, 1980 (Supp.
80-2). Amended effective August 9, 1983 (Supp. 83-4).
Section repealed, new Section adopted effective May 16,
1990 (Supp. 90-2). Amended effective November 1, 1993
(Supp. 93-4). Amended by final rulemaking at 5 A.A.R.
4441, effective November 2, 1999 (Supp. 99-4). Section
repealed by final rulemaking at 10 A.A.R. 1192, effective
May 1, 2004 (Supp. 04-1).
R4-23-404. Unethical Practices
A. Rebates prohibited. A pharmacist or pharmacy permittee shall
not offer, deliver, receive, or accept any unearned rebate,
refund, commission, preference, patronage dividend, discount,
or other unearned consideration, whether in the form of money
or otherwise, as compensation or inducement to refer a patient,
client, or customer to any person, except for a rebate or pre-
mium paid completely and directly to a patient. A pharmacist
or pharmacy permittee shall not:
1. Make payment to a medical practitioner in money or
other consideration for a prescription order prescribed by
the medical practitioner; or
2. Make payment to a long-term care or assisted living facil-
ity or other health care institution in money, discount,
rental, or other consideration in an amount above the pre-
vailing rate for:
a. Prescription medication or devices dispensed or sold
for a patient or resident of the facility or institution;
or
b. Drug selection or drug utilization review services,
drug therapy management services, or other phar-
macy consultation services provided for a patient or
resident of the facility or institution.
B. Prescription order-blank advertising prohibited. A pharmacist
or pharmacy permittee shall not:
1. Directly or indirectly furnish to a medical practitioner a
prescription order-blank that refers to a specific pharma-
cist or pharmacy in any manner; or
2. Actively or passively participate in any arrangement or
agreement where a prescription order-blank is prepared,
written, or issued in a manner that refers to a specific
pharmacist or pharmacy.
C. Fraudulent claim for service. A pharmacist or pharmacy per-
mittee shall not claim the performance of a service that the
pharmacist or pharmacy permittee knows or should know was
not performed, such as, claiming to dispense a prescription
medication that is not dispensed.
D. Fraudulent claim for a fee. A pharmacist or pharmacy permit-
tee:
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 24 Supp. 20-1 March 31, 2020
1. Shall not claim a fee for a service that is not performed or
earned;
2. May divide a prescription order into two or more portions
of prescription medication at the request of a patient, or
for some other ethical reason, and charge a dispensing fee
for the additional service; and
3. Shall not divide a prescription order merely to obtain an
additional fee.
E. Prohibiting a prescription-only drug or device from being dis-
pensed over the counter. A pharmacist shall ensure that:
1. A prescription-only drug or device is dispensed only after
receipt of a valid prescription order from a licensed medi-
cal practitioner;
2. The dispensed prescription-only drug or device is prop-
erly prepared, packaged, and labeled according to this
Chapter; and
3. The prescription order is filed according to this Chapter.
F. Drugs dispensed in the course of the conduct of a business of
dispensing drugs through diagnosis by mail or the internet.
1. A pharmacist shall not dispense a drug from a prescrip-
tion order if the pharmacist has knowledge, or reasonably
should know under the circumstances, that the prescrip-
tion order was issued on the basis of an internet-based
questionnaire or an internet-based consultation without a
medical practitioner-patient relationship as defined in R4-
23-110.
2. A pharmacist who dispenses a prescription-only drug,
prescription-only device, or controlled substance in viola-
tion of this Section is engaging in unethical conduct in
violation of A.R.S. § 32-1901.01.
Historical Note
Former Rules 4.2110, 4.2120, 4.2130, 4.2210, 4.2230,
4.2400, 4.2500, 4.2600, 4.4100, 4.4200, 4.4310, 4.4320,
4.4400, and 4.4500; Amended effective August 10, 1978
(Supp. 78-4); Amended subsection (I) effective August 9,
1983 (Supp. 83-4). Amended by deleting subsections (H)
through (M) effective November 18, 1983 (Supp. 83-6).
Amended by final rulemaking at 8 A.A.R. 1256, effective
March 7, 2002 (Supp. 02-1). Amended by final rulemak-
ing at 14 A.A.R. 3405, effective October 4, 2008 (Supp.
08-3).
R4-23-405. Change of Responsibility
A pharmacist designated as the pharmacist-in-charge for a phar-
macy, manufacturer, or other establishment shall give immediate
notice, as defined in R4-23-110, when:
1. The pharmacist’s responsibility as a pharmacist-in-charge
is terminated; or
2. The pharmacist knows of a pending termination of the
pharmacist’s responsibility as the pharmacist-in-charge.
Historical Note
Former Rules 4.5100 and 4.5200; Amended effective
August 9, 1983 (Supp. 83-4). Amended effective Febru-
ary 8, 1991 (Supp. 91-1). Amended effective November
1, 1993 (Supp. 93-4). Amended by final rulemaking at 8
A.A.R. 1256, effective March 7, 2002 (Supp. 02-1).
R4-23-406. Repealed
Historical Note
Adopted as an emergency effective January 10, 1979,
pursuant to A.R.S. § 41-1003, valid for only 90 days
(Supp. 79-1). Amended as an emergency effective April
2, 1979, pursuant to A.R.S. § 41-1003, valid for only 90
days. Adopted effective April 10, 1979 (Supp. 79-1). For-
mer Section R4-23-406 repealed, new Section R4-23-406
adopted effective August 9, 1983 (Supp. 83-4). Amended
effective April 1, 1995; filed with the Secretary of State
January 31, 1995 (Supp. 95-1). Amended by final
rulemaking at 8 A.A.R. 1256, effective March 7, 2002
(Supp. 02-1). Section repealed by final rulemaking at 10
A.A.R. 230, effective March 6, 2004 (Supp. 04-1).
R4-23-407. Prescription Requirements
A. Prescription orders. A pharmacist shall ensure that:
1. A prescription order the pharmacist uses to dispense a
drug or device includes the following information:
a. Date of issuance;
b. Name and address of the patient for whom or the
owner of the animal for which the drug or device is
dispensed;
c. Drug name, strength, and dosage form or device
name;
d. Name of the manufacturer or distributor of the drug
or device if the prescription order is written generi-
cally or a substitution is made;
e. Prescribing medical practitioner’s directions for use;
f. Date of dispensing;
g. Quantity prescribed and if different, quantity dis-
pensed;
h. For a prescription order for a controlled substance,
the medical practitioner’s address and DEA number;
i. For a written prescription order, the medical practi-
tioner’s signature;
j. For an electronically transmitted prescription order,
the medical practitioner’s digital or electronic signa-
ture;
k. For an oral prescription order, the medical practi-
tioner’s name and telephone number; and
l. Name or initials of the dispensing pharmacist;
2. A prescription order is kept by the pharmacist or phar-
macy permittee as a record of the dispensing of a drug or
device for seven years from the date the drug or device is
dispensed;
3. The dispensing of a drug or device complies with the
packaging requirements of the official compendium and
state and federal law; and
4. If the drug dispensed is a schedule II controlled substance
that is an opioid, the drug is placed in a container that has
a red cap and a warning label stating “CAUTION: OPI-
OID, Risk of Overdose and Addiction” or other similarly
clear language indicating the possibility of overdose and
addiction. Under delegation from the Board, the Execu-
tive Director may waive the red-cap requirement if imple-
menting the requirement is not feasible because of the
specific dosage form or packaging type.
B. Prescription refills. A pharmacist shall ensure that the follow-
ing information is recorded on the back of a prescription order
when it is refilled:
1. Date refilled,
2. Quantity dispensed,
3. Name or approved abbreviation of the manufacturer or
distributor if the prescription order is written generically
or a substitution is made, and
4. The name or initials of the dispensing pharmacist.
C. Prescription order adaptation. Except for a prescription order
for a controlled substance, a pharmacist, using professional
judgment, may make the following adaptations to a prescrip-
tion order if the pharmacist documents the adaptation in the
patient’s record:
1. Change the prescribed quantity if the prescribed quantity
is not a package size commercially available from the
manufacturer;
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 25
2. Change the prescribed dosage form or directions for use
if the change achieves the intent of the prescribing medi-
cal practitioner;
3. Complete missing information on the prescription order if
there is sufficient evidence to support the change; and
4. Extend the quantity of a maintenance drug for the limited
quantity necessary to achieve medication refill synchroni-
zation for the patient.
D. A pharmacist may furnish a copy of a prescription order to the
patient for whom it is prescribed or to the authorized represen-
tative of the patient if the copy is clearly marked “COPY FOR
REFERENCE PURPOSES ONLY” or other similar statement.
A copy of a prescription order is not a valid prescription order
and a pharmacist shall not dispense a drug or device from the
information on a copy.
E. Transfer of prescription order information. For a transfer of
prescription order information to be valid, a pharmacy permit-
tee or pharmacist-in-charge shall ensure that:
1. Both the original and the transferred prescription order
are maintained for seven years after the last dispensing
date;
2. The original prescription order information for a Sched-
ule III, IV, or V controlled substance is transferred only as
specified in 21 CFR 1306.25;
3. The original prescription order information for a non-
controlled substance drug is transferred without limita-
tion only up to the number of originally authorized refills;
4. For a transfer within Arizona:
a. The transfer of original prescription order informa-
tion for a non-controlled substance drug meets the
following conditions:
i. The transfer of information is communicated
electronically, verbally, or by fax directly
between:
(1) Two licensed pharmacists,
(2) A licensed pharmacist and a licensed
intern, or
(3) Two licensed interns;
ii. The following information is recorded by the
transferring pharmacist or intern:
(1) The word “void” is written on the face of
the invalidated original prescription unless
it is an electronic or oral transfer and the
transferred prescription order information
is invalidated in the transferring phar-
macy’s computer system; and
(2) The name and identification code, num-
ber, or address and telephone number of
the pharmacy to which the prescription is
transferred, the name of the receiving
pharmacist or intern, the date of transfer,
and the name of the transferring pharma-
cist or intern is written on the back of the
prescription or entered into the transfer-
ring pharmacy’s computer system; and
iii. The following information is recorded by the
receiving pharmacist or intern on the trans-
ferred prescription order:
(1) The word “transfer;”
(2) Date of issuance of the original prescrip-
tion order;
(3) Original number of refills authorized on
the original prescription order;
(4) Date of original dispensing;
(5) Number of valid refills remaining and the
date of the last refill;
(6) Name and identification code, number, or
address, telephone number, and original
prescription number of the pharmacy from
which the prescription is transferred;
(7) Name of the transferring pharmacist or
intern; and
(8) Name of the receiving pharmacist or
intern;
b. The transfer of original prescription order informa-
tion for a Schedule III, IV, or V controlled substance
meets the following conditions:
i. The transfer of information is communicated
directly between two licensed pharmacists or
interns electronically or verbally;
ii. The following information is recorded by the
transferring pharmacist or intern:
(1) The word “void” is written on the face of
the invalidated original prescription order
unless it is an electronic or oral transfer
and the transferred prescription order
information is invalidated in the transfer-
ring pharmacy’s computer system; and
(2) The name, address, and DEA number of
the pharmacy to which the prescription is
transferred, the name of the receiving
pharmacist, the date of transfer, and the
name of the transferring pharmacist is
written on the back of the prescription
order or entered into the transferring phar-
macy’s computer system; and
iii. The following information is recorded by the
receiving pharmacist on the transferred pre-
scription order:
(1) The word “transfer;”
(2) Date of issuance of original prescription
order;
(3) Original number of refills authorized on
the original prescription order;
(4) Date of original dispensing;
(5) Number of valid refills remaining and the
date of the last refill;
(6) Name, address, DEA number, and original
prescription number of the pharmacy from
which the prescription is transferred;
(7) Name of the transferring pharmacist; and
(8) Name of the receiving pharmacist;
5. For a transfer from out-of-state:
a. The transfer of original prescription order informa-
tion for a non-controlled substance drug meets the
conditions in subsections (E)(4)(a)(i) and
(E)(4)(a)(iii); and
b. The transfer of original prescription order informa-
tion for a Schedule III, IV, or V controlled substance
meets the conditions in subsections (E)(4)(b)(i) and
(E)(4)(b)(iii); and
6. For an electronic transfer, the electronic transfer of origi-
nal prescription order information meets the following
conditions:
a. The electronic transfer is between pharmacies
owned by the same company using a common or
shared database;
b. The electronic transfer of original prescription order
information for a non-controlled substance drug is
performed by a pharmacist or intern, pharmacy tech-
nician trainee, or pharmacy technician under the
supervision of a pharmacist;
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 26 Supp. 20-1 March 31, 2020
c. The electronic transfer of original prescription order
information for a controlled substance is performed
between two licensed pharmacists;
d. The electronic transfer of original prescription order
information for a non-controlled substance drug
meets the following conditions:
i. The transferring pharmacy’s computer system:
(1) Invalidates the transferred original pre-
scription order information;
(2) Records the identification code, number,
or address of the pharmacy to which the
prescription order information is trans-
ferred;
(3) Records the name or identification code of
the receiving pharmacist, intern, pharmacy
technician trainee, or pharmacy techni-
cian; and
(4) Records the date of transfer; and
ii. The receiving pharmacy’s computer system;
(1) Records that a prescription transfer
occurred;
(2) Records the date of issuance of the origi-
nal prescription order;
(3) Records the original number of refills
authorized on the original prescription
order;
(4) Records the date of original dispensing;
(5) Records the number of valid refills
remaining and the date of the last refill;
(6) Records the identification code, number,
or address and original prescription num-
ber of the pharmacy from which the pre-
scription is transferred;
(7) Records the name or identification code of
the receiving pharmacist or intern, phar-
macy technician trainee, or pharmacy
technician; and
(8) Records the date of transfer;
e. The electronic transfer of original prescription order
information for a controlled substance meets the fol-
lowing conditions:
i. The transferring pharmacy’s computer system:
(1) Invalidates the transferred original pre-
scription order information;
(2) Records the identification code, number,
or address, and DEA number of the phar-
macy to which the prescription order
information is transferred;
(3) Records the name or identification code of
the receiving pharmacist;
(4) Records the date of transfer; and
(5) Records the name or identification code of
the transferring pharmacist; and
ii. The electronic prescription order information
received by the computer system of the receiv-
ing pharmacy includes the information required
in subsection (E)(4)(b)(iii); and
f. In addition to electronic documentation of a trans-
ferred prescription order in the computer system, an
original prescription order containing the require-
ments of this Section is filed in compliance with
A.R.S. § 32-1964.
F. Transmission of a prescription order from a medical practi-
tioner to a pharmacy by fax.
1. A medical practitioner or medical practitioner’s agent
may transmit a prescription order for a Schedule III, IV,
or V controlled substance, prescription-only drug, or non-
prescription drug to a pharmacy by fax under the follow-
ing conditions:
a. The prescription order is faxed only to the pharmacy
of the patient’s choice;
b. The faxed prescription order:
i. Contains all the information required for a pre-
scription order in A.R.S. §§ 32-1968 and 36-
2525; and
ii. Is only faxed from the medical practitioner’s
practice location, except that a nurse in a hospi-
tal, long-term care facility, or inpatient hospice
may send a fax of a prescription order for a
patient of the facility; and
c. The faxed prescription order shall contain the fol-
lowing additional information:
i. The date the prescription order is faxed;
ii. The fax number of the prescribing medical
practitioner or the facility from which the pre-
scription order is faxed, and the telephone num-
ber of the facility; and
iii. The name of the person who transmits the fax,
if other than the medical practitioner.
2. A medical practitioner or medical practitioner’s agent
may fax a prescription order for a Schedule II controlled
substance for information purposes only, unless the faxed
prescription order meets the requirements of A.R.S. § 36-
2525(F) and (G).
3. A pharmacy may receive a faxed prescription order for a
Schedule II controlled substance for information pur-
poses only, except a faxed prescription order for a Sched-
ule II controlled substance that meets the requirements of
A.R.S. § 36-2525(F) and (G) may serve as the original
written prescription order.
4. To meet the seven-year record retention requirement of
A.R.S. § 32-1964, a pharmacy shall receive a faxed pre-
scription order on plain paper or may make a photocopy
of the faxed prescription order.
5. A medical practitioner or the medical practitioner’s agent
may fax refill authorizations to a pharmacy if the faxed
authorization includes the medical practitioner’s tele-
phone and fax numbers, the medical practitioner’s signa-
ture or medical practitioner’s agent’s name, and date of
authorization.
G. Electronic transmission of a prescription order from a medical
practitioner to a pharmacy.
1. Unless otherwise prohibited by law, a medical practi-
tioner or medical practitioner’s agent may transmit a pre-
scription order by electronic means, directly or through
an intermediary, including an E-prescribing network, to
the dispensing pharmacy as specified in A.R.S. § 32-
1968.
2. For electronic transmission of a Schedule II, III, IV, or V
controlled substance prescription order, the medical prac-
titioner and pharmacy shall ensure the transmission com-
plies with any security or other requirements of federal
law.
3. The medical practitioner and pharmacy shall ensure all
electronic transmissions comply with all the security
requirements of state or federal law related to the privacy
of protected health information.
4. In addition to the information required to be included on a
prescription order as specified in A.R.S. § 32-1968, a
medical practitioner shall ensure an electronically trans-
mitted prescription order includes:
a. The date of transmission; and
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 27
b. If the individual transmitting the prescription is not
the medical practitioner, the name of the medical
practitioner’s authorized agent who transmits the
prescription order.
5. A pharmacy receiving an electronically transmitted pre-
scription order shall maintain the prescription order as
specified in A.R.S. § 32-1964 or R4-23-408(H)(2).
6. A medical practitioner or medical practitioner’s agent
shall transmit an electronic prescription order only to the
pharmacy of the patient’s choice.
H. Exceptions under A.R.S. § 36-2525 regarding electronic pre-
scribing requirements:
1. Medical practitioner exceptions. A medical practitioner
who is authorized to prescribe a controlled substance may
furnish a written prescription order is accordance with
R4-23-407 rather than an electronically transmitted pre-
scription order if the prescription order is written:
a. In this state to be filled in a jurisdiction outside this
state;
b. For a medication that requires compounding two or
more ingredients;
c. For a medication that is not in the E-prescribing
database;
d. For an individual who is detained by or in custody of
an Arizona or federal law enforcement agency; or
e. Under A.R.S. § 36-2525(N) or (O); and
2. Pharmacist exceptions. A pharmacist may dispense a
controlled substance from a written rather than electroni-
cally transmitted prescription order if the prescription
order:
a. Is written by a medical practitioner who is not
licensed in this state but rather, is licensed in a juris-
diction outside this state. The pharmacist is not
required to verify whether the medical practitioner is
licensed;
b. Is written for a medication that requires compound-
ing two or more ingredients;
c. Is written for a medication that is not in the E-pre-
scribing database;
d. Is written for an individual who is detained by or in
custody of an Arizona or federal law enforcement
agency; or
e. Is received under A.R.S. § 36-2525(D).
Historical Note
Adopted effective November 18, 1983 (Supp. 83-6).
Amended by final rulemaking at 8 A.A.R. 1256, effective
March 7, 2002 (Supp. 02-1). Amended by final rulemak-
ing at 10 A.A.R. 1192, effective May 1, 2004 (Supp. 04-
1). Amended by final rulemaking at 13 A.A.R. 440, effec-
tive April 7, 2007 (Supp. 07-1). Amended by final
rulemaking at 14 A.A.R. 3605, effective November 8,
2008 (Supp. 08-3). Amended by final rulemaking at 25
A.A.R. 1015, effective June 1, 2019 (Supp. 19-2).
Amended by final rulemaking at 26 A.A.R. 223, effective
March 14, 2020; and amended by final rulemaking at 26
A.A.R. 544, with an immediate effective date of March 3,
2020 (Supp. 20-1).
R4-23-407.1. Dispensing an Opioid Antagonist
A. As used in this Section:
1. “Community member” means any person in position to
assist an individual at risk of experiencing an opioid-
related overdose. This includes emergency first respond-
ers, peace officers or other law enforcement personnel,
fire department personnel, school district employees, and
personnel of a facility or center that provides services to
individuals at risk of experiencing an opioid-related over-
dose.
2. “Opioid antagonist” means any drug approved by the
U.S. Food and Drug Administration that binds to opioid
receptors, effectively blocking or inhibiting the receptor
and preventing the body from responding to the opioid.
Naloxone hydrochloride is an opioid antagonist.
3. “Opioid-related overdose” means an acute condition
caused by excessive opioids. An opioid-related overdose
can be identified by a triad of symptoms: decreased level
of consciousness, pinpoint pupils, and respiratory depres-
sion. Other symptoms may include seizures, muscle
spasms, and coma or death. An opioid-related overdose
requires medical assistance.
B. When dispensing an opioid antagonist under A.R.S. § 32-
1979, a pharmacist or pharmacy intern shall provide the fol-
lowing education to the individual to whom the opioid antago-
nist is dispensed:
1. How to prevent an opioid-related overdose;
2. How to recognize an opioid-related overdose;
3. How to administer an opioid antagonist safely to an indi-
vidual experiencing an opioid-related overdose;
4. Precautions regarding:
a. Potential side effects, and
b. Possible adverse events associated with administra-
tion of the opioid antagonist; and
5. Importance of seeking emergency medical assistance for
the individual experiencing an opioid-related overdose
before or after administering the opioid antagonist.
C. Before dispensing an opioid antagonist under A.R.S. § 32-
1979(A), a licensed pharmacist shall complete an opioid pre-
vention and treatment training program that includes the fol-
lowing information:
1. How to recognize the symptoms of an opioid-related
overdose,
2. How to respond to a suspected opioid-related overdose,
3. How to administer all preparations of an opioid antago-
nist, and
4. The information needed by an individual to whom an opi-
oid antagonist is dispensed.
D. A pharmacist who has completed an opioid prevention and
treatment training program described in subsection (C):
1. May administer an opioid antagonist to an individual the
pharmacist believes is experiencing an opioid-related
overdose, and
2. Is exempt from civil liability under the terms of A.R.S. §
36-2267(B).
E. Dispensing an opioid antagonist under A.R.S. § 32-1979 by
invoice to a community member is not wholesale distribution
as defined at A.R.S. § 32-1981.
F. When dispensing an opioid antagonist on a standing order, as
defined under A.R.S. § 32-1968, a pharmacist or pharmacy
intern shall comply with R4-23-407 except subsection
(A)(1)(b), R4-23-408, and R4-23-409.
Historical Note
New Section made by emergency rulemaking at 23
A.A.R. 31, effective December 15, 2016 for 180 days
(Supp. 16-4). New Section made by final rulemaking
before emergency expired at 23 A.A.R. 967, effective
June 3, 2017 (Supp. 17-2). Amended by final rulemaking
at 25 A.A.R. 1015, effective June 1, 2019 (Supp. 19-2).
R4-23-408. Computer Records
A. Systems manual. A pharmacy permittee or pharmacist-in-
charge shall:
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 28 Supp. 20-1 March 31, 2020
1. Develop, implement, and comply with policies and pro-
cedures for the following operational aspects of a com-
puter system:
a. Examples of all output documentation provided by
the computer system that contains original or refill
prescription order or patient profile information;
b. Steps a pharmacy employee follows when the com-
puter system is not operational due to scheduled or
unscheduled system interruption;
c. Regular and routine backup file procedure and file
maintenance, including secure storage of backup
files;
d. Audit procedures, personnel code assignments, and
personnel responsibilities; and
e. Quality assurance mechanism for data entry valida-
tion;
2. Review biennially and, if necessary, revise the policies
and procedures required under this Section;
3. Document the review required under subsection (A)(2);
4. Assemble the policies and procedures as a written manual
or by another method approved by the Board or its desig-
nee; and
5. Make the policies and procedures available within the
pharmacy for reference by pharmacy personnel and
inspection by the Board or its designee.
B. Computer system data storage and retrieval. A pharmacy per-
mittee or pharmacist-in-charge shall ensure the computer sys-
tem is capable of:
1. Producing sight-readable information on all original and
refill prescription orders and patient profiles;
2. Providing online retrieval (via CRT display or hard-copy
printout) of original prescription order information
required in A.R.S. § 32-1968(C), R4-23-402(A), and R4-
23-407(A);
3. Providing online retrieval (via CRT display or hard-copy
printout) of patient profile information required in R4-23-
402(A);
4. Providing documentation identifying the pharmacist
responsible for dispensing each original or refill prescrip-
tion order, except a pharmacy permittee with a computer
system that is in use before the effective date of this Sec-
tion that cannot provide documentation identifying the
dispensing pharmacist may continue to use the computer
system by providing manual documentation identifying
the dispensing pharmacist;
5. Producing a printout of all prescription order information,
including a single-drug usage report that contains:
a. The name of the prescribing medical practitioner;
b. The name and address of the patient;
c. The quantity dispensed on each original or refill pre-
scription order;
d. The date of dispensing for each original or refill pre-
scription order;
e. The name or identification code of the dispensing
pharmacist; and
f. The serial number of each prescription order; and
6. Providing a printout of requested prescription order infor-
mation to an individual pharmacy within 72 hours of the
request if prescription order information is maintained in
a centralized computer record system.
C. A pharmacy permittee or pharmacist-in-charge of a pharmacy
that uses a pharmacy computer system:
1. Shall notify the D.E.A. and the Board in writing that orig-
inal and refill prescription order information and patient
profiles are stored in a pharmacy computer system;
2. Shall comply with this Section if the pharmacy computer
system’s refill records are used as an alternative to the
manual refill records required in R4-23-407(B);
3. Is exempt from the manual refill recordkeeping require-
ments of R4-23-407(B), if the pharmacy computer sys-
tem complies with the requirements of this Section; and
4. Shall ensure that documentation of the accuracy of origi-
nal and refill prescription order information entered into a
computer system is provided by each pharmacist using
the computer system and kept on file in the pharmacy for
seven years from the date of the last refill. Documenta-
tion includes one of the following:
a. A hard-copy printout of each day’s original and refill
prescription order data that:
i. States original and refill data for prescriptions
dispensed by each pharmacist is reviewed for
accuracy;
ii. Includes the printed name of each dispensing
pharmacist; and
iii. Is signed and initialed by each dispensing phar-
macist; or
b. A log book or separate file of daily statements that:
i. States original and refill data for prescriptions
dispensed by each pharmacist is reviewed for
accuracy;
ii. Includes the printed name of each dispensing
pharmacist; and
iii. Is signed and initialed by each dispensing phar-
macist.
D. If a pharmacy computer system does not comply with the
requirements of subsections (A), (B), and (F), the pharmacy
permittee or pharmacist-in-charge shall bring the computer
system into compliance within three months of a notice of
noncompliance or violation letter. If the computer system is
still noncompliant with subsection (A), (B), or (F) after three
months, the pharmacy permittee or pharmacist-in-charge shall
immediately comply with the manual recordkeeping require-
ments of R4-23-402 and R4-23-407.
E. If a pharmacy’s personnel perform manual recordkeeping
under subsection (D), the pharmacy’s personnel shall continue
manual recordkeeping until the pharmacist-in-charge sends
proof, verified by a Board compliance officer, that the com-
puter system complies with subsections (A), (B), and (F).
F. Security. To maintain the confidentiality of patient records, a
pharmacy permittee or pharmacist-in-charge shall ensure:
1. The computer system has security and systems safe-
guards designed to prevent and detect unauthorized
access, modification, or manipulation of prescription
order information and patient profiles; and
2. After a prescription order is dispensed, any alteration of
prescription order information is documented, including
the identification of the pharmacist responsible for the
alteration.
G. A computer system that does not comply with all the require-
ments of subsections (A), (B), and (F) may be used in a phar-
macy if:
1. The computer system was in use in the pharmacy before
July 11, 2001, and
2. The pharmacy complies with the manual recordkeeping
requirements of R4-23-402 and R4-23-407.
H. Prescription records and retention.
1. Instead of filing the original hard-copy prescription order
as required in A.R.S. § 32-1964, a pharmacy permittee or
pharmacist-in-charge may use an electronic imaging
recordkeeping system, if:
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 29
a. The system is capable of capturing, storing, and
reproducing the exact image of a prescription order,
including the reverse side of the prescription order if
necessary;
b. Any notes of clarification of or alterations to a pre-
scription order are directly associated with the elec-
tronic image of the prescription order;
c. A prescription order image and any associated notes
of clarification of or alterations to the prescription
order are retained for no fewer than seven years
from the date the prescription order is last dispensed;
d. Policies and procedures for the use of an electronic
imaging recordkeeping system are developed,
implemented, reviewed, and revised in the same
manner described in subsection (A) and complied
with; and
e. The prescription is not for a controlled substance.
2. If a pharmacy’s computer system fields are automatically
populated by an electronically transmitted prescription
order, the automated record constitutes the original pre-
scription order and a hard-copy or electronic image is not
required if the computer system is capable of maintain-
ing, printing, and providing all the prescription order
information required in A.R.S. §§ 32-1968 and 36-2525
and R4-23-407(A) within 72 hours of a request by the
Board, the Board’s compliance officers, other authorized
regulatory board agents, or authorized officers of the law.
I. A pharmacy permittee or pharmacist-in-charge shall
make all prescription records available within 72 hours
after a Board request.
Historical Note
Adopted effective November 18, 1983 (Supp. 83-6).
Amended by final rulemaking at 7 A.A.R. 646, effective
January 11, 2001 (Supp. 01-1). Amended by final
rulemaking at 9 A.A.R. 5030, effective January 3, 2004
(Supp. 03-4). Amended by final rulemaking at 11 A.A.R.
4270, effective December 6, 2005 (Supp. 05-4).
Amended by final rulemaking at 12 A.A.R. 274, effective
March 11, 2006 (Supp. 06-1). Amended by final rulemak-
ing at 12 A.A.R. 3032, effective October 1, 2006 (Supp.
06-3). Amended by final rulemaking at 13 A.A.R. 440,
effective April 7, 2007 (Supp. 07-1). Amended by final
rulemaking at 26 A.A.R. 223, effective March 14, 2020
(Supp. 20-1).
R4-23-409. Returning Drugs and Devices
A. After a person for whom a drug is prescribed or the person’s
agent takes the drug from the premises where sold, distributed,
or dispensed, a pharmacist or pharmacy permittee shall not
accept the drug for return or exchange for the purpose of resale
unless the pharmacist determines that:
1. The drug is in its original, manufacturer’s, unopened con-
tainer; and
2. The drug or its container has not been subjected to con-
tamination or deterioration.
B. The provisions of subsection (A) of this Section do not apply
to a drug dispensed to:
1. A hospital inpatient as defined in R4-23-651; or
2. A resident of a long-term care facility where a licensed
health care professional administers the drug, and the
pharmacist ensures and documents that the drug:
a. Has been stored in compliance with the require-
ments of the official compendium; and
b. Is not obviously contaminated or deteriorated.
C. After a person for whom a device is prescribed or the person’s
agent takes the device from the premises where sold, distrib-
uted, or dispensed, a pharmacist or pharmacy permittee shall
not accept the device for return or exchange for the purpose of
resale or reuse unless the pharmacist determines that:
1. The device is inspected and is free of defects;
2. The device is rendered incapable of transferring disease;
and
3. The device, if resold or reused, is not claimed to be new
or unused.
Historical Note
Adopted effective November 18, 1983 (Supp. 83-6).
Amended by final rulemaking at 8 A.A.R. 1256, effective
March 7, 2002 (Supp. 02-1).
R4-23-410. Current Good Compounding Practices
A. This Section establishes the current good compounding prac-
tices to be used by a pharmacist licensed by the Board, in a
pharmacy permitted by the Board, and in compliance with
applicable federal and state law governing the practice of phar-
macy.
B. A pharmacy permittee shall ensure compliance with the provi-
sions in this subsection.
1. All substances for compounding that are received, stored,
or used by the pharmacy permittee:
a. Meet official compendium requirements;
b. Are of high quality, such as Chemically Pure (CP),
Analytical Reagent (AR), certified American Chem-
ical Society (ACS), or Food Chemical Codex (FCC)
grade; or
c. Are obtained from a source that, in the professional
judgment of the pharmacist, is acceptable and reli-
able.
2. Before compounding a pharmaceutical product in excess
of the quantity dispensed in anticipation of receiving
valid prescriptions for the pharmaceutical product, a
pharmacist, employed by the pharmacy permittee, shall
establish a history of compounding valid prescriptions for
the pharmaceutical product.
3. Neither the pharmacy permittee nor a pharmacist
employed by the pharmacy permittee provides a com-
pounded pharmaceutical product to a pharmacy, medical
practitioner, or other person for dispensing or distributing
except that a compounded pharmaceutical product may
be provided to a medical practitioner to administer to a
patient of the medical practitioner if each container is
accompanied by the written list required in subsection
(I)(5) and has a label that includes the following:
a. The pharmacy’s name, address, and telephone num-
ber;
b. The pharmaceutical product’s name and the infor-
mation required in subsection (I)(4);
c. A lot or control number;
d. A beyond-use-date based upon the pharmacist’s pro-
fessional judgment, but not more than the maximum
guidelines recommended in the Pharmacy Com-
pounding Practices chapter of the official compen-
dium unless there is published or unpublished
stability test data that shows a longer period is
appropriate;
e. The statement “Not For Dispensing;” and
f. The statement “For Office or Hospital Administra-
tion Only.”
4. A pharmacy or pharmacist may advertise or otherwise
promote the fact that the pharmacy or pharmacist pro-
vides prescription compounding services.
C. A pharmacy permittee shall ensure compliance with the orga-
nization, training, and personnel issues in this subsection.
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 30 Supp. 20-1 March 31, 2020
1. Before dispensing a compounded pharmaceutical prod-
uct, a pharmacist:
a. Inspects and approves or rejects, or assumes respon-
sibility for inspecting and approving or rejecting,
components, pharmaceutical product containers and
closures, in-process materials, and labeling;
b. Prepares or assumes responsibility for preparing all
compounding records;
c. Reviews all compounding records to ensure that no
errors occur in the compounding process;
d. Ensures the proper use, cleanliness, and mainte-
nance of all compounding equipment; and
e. Documents by hand-written initials or signature in
the compounding record the completion of the
requirements of subsections (C)(1)(a), (b), (c), and
(d).
2. A pharmacist engaged in compounding:
a. Complies with the current good compounding prac-
tices and applicable state pharmacy laws;
b. Maintains compounding proficiency through current
awareness, training, and continuing education; and
c. Ensures that personnel engaged in compounding
wear:
i. Clean clothing appropriate to the work per-
formed; and
ii. Protective apparel, such as coats, aprons,
gowns, gloves or masks to protect the person-
nel from chemical exposure and prevent phar-
maceutical product contamination.
D. A pharmacy permittee shall ensure the security, safety, and
quality of a compounded pharmaceutical product by conform-
ing with the following standards:
1. Implement procedures to exclude from direct contact
with components, pharmaceutical product containers and
closures, in-process materials, labeling, and pharmaceuti-
cal products, any person with an apparent illness or open
lesion that may adversely affect the safety or quality of a
compounded pharmaceutical product, until the illness or
lesion, as determined by competent medical personnel,
does not jeopardize the safety or quality of a compounded
pharmaceutical product; and
2. Require all personnel to inform a pharmacist of any
health condition that may adversely affect a compounded
pharmaceutical product.
E. A pharmacy permittee shall provide compounding facilities
that conform with the standards in this subsection.
1. In addition to the minimum area requirements of R4-23-
609, R4-23-655, or R4-23-673, the compounding area:
a. Complies with the requirements in R4-23-611; and
b. Has sufficient space to permit efficient pharmacy
practice, free movement of personnel, and visual
surveillance by a pharmacist.
2. If sterile pharmaceutical product or radiopharmaceutical
product compounding is performed, the compounding
area complies with the requirements of R4-23-670, R4-
23-681, and R4-23-682.
3. A clean, dry, and temperature-controlled area and, if
required, a refrigerated area, in which to store properly
labeled containers of bulk drugs, chemicals, and materials
used in compounding, that complies with state statutes
and rules.
F. To protect pharmaceutical product safety, identity, strength,
quality, and purity, a pharmacy permittee shall ensure that
equipment and utensils used in pharmaceutical product com-
pounding are:
1. Of appropriate design, adequate size, and suitably located
for proper operation, cleaning, and maintenance;
2. Made of material that is not reactive, additive, or absorp-
tive when exposed to components, in-process materials,
or pharmaceutical products;
3. Cleaned and protected from contamination before use;
4. Inspected and determined suitable for use before initia-
tion of compounding operations; and
5. Routinely inspected, calibrated, or checked to make
proper performance certain.
G. A pharmacy permittee shall ensure that the pharmacist-in-
charge establishes, implements, and complies with procedures
to prevent cross-contamination when pharmaceutical products
that require special precautions to prevent cross-contamina-
tion, such as penicillin, are used in a compounding procedure.
The procedures shall include either the dedication of equip-
ment or the meticulous cleaning of contaminated equipment
before its use in compounding other pharmaceutical products.
H. A pharmacy permittee shall ensure that the pharmacist-in-
charge establishes, implements, and complies with control
procedures for components and pharmaceutical product con-
tainers and closures, either written or electronically stored
with printable documentation, that conform with the standards
in this subsection.
1. Components and pharmaceutical product containers and
closures are:
a. Stored off the floor,
b. Handled and stored to prevent contamination, and
c. Rotated so the oldest approved stock is used first.
2. Container closure systems comply with official compen-
dium standards.
3. Pharmaceutical product containers and closures are clean
and made of material that is not reactive, additive, or
absorptive.
I. A pharmacy permittee shall ensure that the pharmacist-in-
charge establishes, implements, and complies with pharma-
ceutical product compounding controls that conform with the
standards in this subsection.
1. Pharmaceutical product compounding procedures are
available in either written form or electronically stored
with printable documentation:
a. To ensure that a finished pharmaceutical product has
the identity, strength, quality, and purity it is pur-
ported or represented to possess, the procedures
include, for each pharmaceutical product com-
pounded, a description of:
i. The components, their manufacturer, lot num-
ber, expiration date, and amounts, the order of
component addition, if applicable, and the com-
pounding process;
ii. The equipment and utensils used; and
iii. The pharmaceutical product container and clo-
sure system proper for the sterility and stability
of the pharmaceutical product as it is intended
to be used.
b. To test the pharmaceutical product being com-
pounded, the procedures monitor the output and val-
idate the performance of compounding processes
that may cause variability in the final pharmaceuti-
cal product, including assessing:
i. Dosage form weight variation;
ii. Adequacy of mixing to ensure uniformity and
homogeneity; and
iii. Clarity, completeness, and pH of solutions, if
applicable.
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 31
2. Components for pharmaceutical product compounding
are accurately weighed, measured, or subdivided. To
ensure that each weight, measure, or subdivision is cor-
rect as stated in the compounding procedures, a pharma-
cist:
a. Checks and rechecks, or assumes responsibility for
checking and re-checking, the operations at each
stage of the compounding process; and
b. Documents by hand-written initials or signature the
completion and accuracy of the compounding pro-
cess.
3. Compounding equipment and utensils are properly
cleaned and maintained.
4. In addition to the labeling requirements of A.R.S. § 32-
1968(D), the label contains:
a. A statement, symbol, designation, or abbreviation
that the pharmaceutical product is a compounded
pharmaceutical product, and
b. A beyond-use-date as specified in subsection
(B)(3)(d).
5. A written list of the compounded pharmaceutical prod-
uct’s active ingredients is given to the patient at the time
of dispensing.
6. When a component is removed from its original container
and transferred to another container, the new container
label contains, in full text or an abbreviated code system,
the following:
a. The component name,
b. The manufacturer’s or supplier’s name,
c. The lot or control number,
d. The weight or measure,
e. The beyond-use-date as specified in subsection
(B)(3)(d), and
f. The transfer date.
J. A pharmacy permittee shall ensure that the pharmacist-in-
charge stores any quantity of compounded pharmaceutical
product produced in excess of the quantity dispensed in accor-
dance with subsection (B):
1. In an appropriate container with a label that contains:
a. A complete list of components or the pharmaceutical
product’s name;
b. The preparation date;
c. The assigned lot or control number; and
d. A beyond-use-date as specified in subsection
(B)(3)(d); and
2. Under conditions, dictated by the pharmaceutical prod-
uct’s composition and stability characteristics, that ensure
its strength, quality, and purity.
K. A pharmacy permittee shall ensure that the pharmacist-in-
charge establishes, implements, and complies with record-
keeping procedures that comply with this subsection:
1. Pharmaceutical product compounding procedures and
other records required by this Section are maintained by
the pharmacy for not less than seven years, and
2. Pharmaceutical product compounding procedures and
other records required by this Section are readily avail-
able for inspection by the Board or its designee.
Historical Note
Adopted effective August 5, 1997 (Supp. 97-3).
Amended by final rulemaking at 10 A.A.R. 3391, effec-
tive October 2, 2004 (Supp. 04-3). Amended by final
rulemaking at 12 A.A.R. 3981, effective December 4,
2006 (Supp. 06-4).
R4-23-411. Pharmacist-administered or Intern-adminis-
tered Immunizations
A. Authorization to administer immunizations, vaccines, and
emergency medications, as defined at A.R.S. § 32-1974(N), to
an eligible adult patient or eligible minor patient. As used in
this Section, “eligible adult patient” means an eligible patient
13 years of age or older and “eligible minor patient” means an
eligible patient at least three years of age but less than 13 years
of age. A pharmacist or an intern in the presence of and under
the immediate personal supervision of a pharmacist, may
administer, without a prescription, immunizations, vaccines,
and emergency medications to an eligible adult patient or eli-
gible minor patient, if:
1. Both the pharmacist and intern meet the qualifications
and standards specified by A.R.S. § 32-1974 and this
Section;
2. The Board authorizes both the pharmacist and intern as
specified in subsection (D);
3. For an eligible adult patient, the immunization or vaccine
is:
a. Recommended for adults by the United States Cen-
ters for Disease Control and Prevention; or
b. Recommended by the United States Centers for Dis-
ease Control and Prevention’s Health Information
for International Travel;
4. For an eligible adult patient, the immunization or vaccine
is not on the Arizona Department of Health Services list
specified in A.A.C. R9-6-1301 as required under A.R.S. §
32-1974(I);
5. For an eligible minor patient, the immunization or vac-
cine is for influenza or a booster dose as described under
A.R.S. § 32-1974(B)(2); and
6. For an eligible minor patient, any immunizations or vac-
cines other than influenza or a booster dose as described
under A.R.S. § 32-1974(B)(2) are administered in
response to a public health emergency declared by the
Governor under A.R.S. § 36-787.
B. A pharmacist or an intern in the presence of and under the
immediate personal supervision of a pharmacist, may adminis-
ter, with a prescription, any immunizations, vaccines, and
emergency medications to an eligible adult patient or eligible
minor patient, if:
1. Both the pharmacist and intern meet the qualifications
and standards specified by A.R.S. § 32-1974 and this
Section; and
2. The Board authorizes both the pharmacist and intern as
specified in subsection (D).
C. A pharmacist or intern who is authorized to administer immu-
nizations, vaccines, and emergency medications to an eligible
adult patient or eligible minor patient shall:
1. Not delegate the authority to any other pharmacist,
intern, or employee; and
2. Maintain their current certificate for inspection by the
Board or its designee or review by the public.
D. Qualifications to administer immunizations, vaccines, and
emergency medications to an eligible adult patient or eligible
minor patient. After receipt of a completed application form,
the Board shall authorize the administration of immunizations,
vaccines, and emergency medications to an eligible adult
patient or eligible minor patient by a pharmacist or intern who
meets the following qualifications:
1. Has a current license to practice pharmacy in this state,
2. Successfully completes a training program specified in
subsection (E), and
3. Has a current certificate in basic cardiopulmonary resus-
citation.
E. Immunizations training program requirements. A training pro-
gram for pharmacists or interns to administer immunizations,
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 32 Supp. 20-1 March 31, 2020
vaccines, and emergency medications to an eligible adult
patient or eligible minor patient shall include the following
courses of study:
1. Basic immunology and the human immune response;
2. Mechanics of immunity, adverse effects, dose, and
administration schedule of available vaccines;
3. Response to an emergency situation as a result of the
administration of an immunization, vaccine, or medica-
tion including administering an emergency medication to
counteract the adverse effects of the immunization, vac-
cine, or medication given;
4. Administration of intramuscular injections;
5. Other immunization administration methods; and
6. Recordkeeping and reporting requirements specified in
subsection (F).
F. Recordkeeping and reporting requirements.
1. A pharmacist or intern authorized under this Section to
administer immunizations, vaccines, and emergency
medications to an eligible patient shall provide to the
pharmacy the following information and documentation
regarding each immunization, vaccine, or emergency
medication administered:
a. The name, address, and date of birth of the patient;
b. The date of administration and site of injection;
c. The name, dose, manufacturer’s lot number, and
expiration date of the vaccine, immunization, or
emergency medication;
d. The name and address of the patient’s identified pri-
mary-care provider or physician;
e. The name of the pharmacist or intern administering
the immunization, vaccine, or emergency medica-
tion;
f. A record of the pharmacist’s or intern’s consultation
with the patient determining that the patient is an eli-
gible patient as defined in R4-23-110;
g. Consultation or other professional information pro-
vided to the patient by the pharmacist or intern;
h. The name and date of the immunization or vaccine
information sheet provided to the patient; and
i. For an immunization or vaccine given to an eligible
minor patient, a consent form signed by the minor’s
parent or guardian.
2. As required under A.R.S. § 32-1974(F)(1), the pharma-
cist or intern shall provide a written or electronic report to
the patient’s primary-care provider or physician contain-
ing the documentation required in subsection (F)(1)(a)
through (d). The pharmacy shall document the time and
date the report is sent and make the record of compliance
with this subsection available in the pharmacy or on
request, within 72 hours, for inspection by the Board or
its designee.
3. A pharmacy’s pharmacist-in-charge or permittee shall
maintain the records required in subsection (F)(1) in the
pharmacy or database for a minimum of seven years from
the administration date.
G. Confidentiality of records. A pharmacist, intern, pharmacy
permittee, or pharmacist-in-charge shall comply with applica-
ble state and federal privacy statutes and rules when releasing
patient health information.
H. Pharmacist-administered or intern-administered adult immuni-
zations that require a prescription order. A pharmacist or intern
authorized by the Board to administer adult immunizations or
vaccines shall not administer any immunization or vaccine
listed in A.A.C. R9-6-1301 without a prescription order. In
addition to filing a prescription order as required in A.R.S. §
32-1964, a pharmacist or pharmacy intern who administers an
immunization or vaccine listed in A.A.C. R9-6-1301 shall
comply with the recordkeeping requirements of subsection
(F)(1).
Historical Note
New Section made by final rulemaking at 10 A.A.R.
3967, effective November 13, 2004 (Supp. 04-3).
Amended by final rulemaking at 12 A.A.R. 279, effective
March 11, 2006 (Supp. 06-1). Amended by final rulemak-
ing at 14 A.A.R. 3674, effective November 8, 2008
(Supp. 08-3). Amended by final rulemaking at 15 A.A.R.
1930, effective November 3, 2009 (Supp. 09-4).
Amended by final rulemaking at 17 A.A.R. 2596, effec-
tive February 4, 2012 (Supp. 11-4). Amended by final
rulemaking at 23 A.A.R. 211, effective March 5, 2017
(Supp. 17-1). Amended by final rulemaking at 25 A.A.R.
1015, effective June 1, 2019 (Supp. 19-2). Amended by
final rulemaking at 26 A.A.R. 223, effective March 14,
2020 (Supp. 20-1).
R4-23-412. Emergency Refill Prescription Dispensing
A. When a state of emergency is declared under A.R.S. § 32-
1910(A) or (B) and the state of emergency results in individu-
als being unable to refill existing prescriptions, a pharmacist
may work in the affected county, city, or town and may dis-
pense a one-time emergency refill prescription of up to a 30-
day supply of a prescribed medication to an affected individual
if both of the following apply:
1. In the pharmacist’s professional opinion the medication is
essential to the maintenance of life or to the continuation
of therapy, and
2. The pharmacist makes a good faith effort to reduce the
information to a written prescription marked “emergency
prescription” and files and maintains the prescription as
required by law.
B. If the state of emergency declared under A.R.S. § 32-1910(A)
or (B) continues for at least 21-days after the pharmacist dis-
penses an emergency prescription under subsection (A), the
pharmacist may dispense one additional emergency refill pre-
scription of up to a 30-day supply of the prescribed medication
if the pharmacist complies with subsection (A)(2).
C. A pharmacist’s authority to dispense emergency prescriptions
under this Section ends when the declared state of emergency
is terminated.
Historical Note
New Section made by final rulemaking at 14 A.A.R.
4400, effective January 3, 2009 (Supp. 08-4).
R4-23-413. Temporary Recognition of Nonresident Licen-
sure
A. When a state of emergency is declared under A.R.S. § 32-
1910(A) or (B):
1. A pharmacist who is not licensed in this state, but who is
currently licensed in another state, may dispense pre-
scription medications in those affected counties, cities, or
towns in this state during the time that a declared state of
emergency exists under A.R.S. § 32-1910(A) or (B) if
both of the following apply:
a. The pharmacist provides proof of current licensure
in another state, and
b. The pharmacist is engaged in a relief effort during a
state of emergency.
2. Acting under the direct supervision of a pharmacist, a phar-
macy technician or pharmacy intern not licensed in this state,
but currently licensed or registered in another state, may assist
a pharmacist in dispensing prescription medications in
affected counties, cities, or towns in this state during the time
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 33
that a declared state of emergency exists under A.R.S. § 32-
1910(A) or (B) if both of the following apply:
a. The pharmacy technician or pharmacy intern provides
proof of current licensure or registration in another state,
and
b. The pharmacy technician or pharmacy intern is engaged
in a relief effort during a state of emergency.
B. The recognition of nonresident licensure or registration shall
end with the termination of the declared state of emergency.
Historical Note
New Section made by final rulemaking at 14 A.A.R.
4400, effective January 3, 2009 (Supp. 08-4).
R4-23-414. Reserved
R4-23-415. Impaired Licensees – Treatment and Rehabilita-
tion
A. The Board may contract with qualified organizations to oper-
ate a program for the treatment and rehabilitation of licensees
impaired as the result of alcohol or other drug abuse, pursuant
to A.R.S. § 32-1932.01.
B. Participants in the program are either “confidential” or
“known.” Confidential participants are self-referred and may
remain unidentified to the Board, subject to maintaining com-
pliance with their program contract. Known participants are
under Board order to complete a minimum tenure in the pro-
gram. After a known participant completes the minimum ten-
ure, the Board may terminate the Board order and reinstate the
participant’s license to practice pharmacy.
C. The program contract with a qualified organization shall
include as a minimum the following:
1. Duties and responsibilities of each party.
2. Duration, not to exceed two years, of contract and terms
of compensation.
3. Quarterly reports from the program administrator to the
Board indicating:
a. Identity of participants;
i. By name, if a known participant; or
ii. By case number, if a confidential participant;
b. Status of each participant, including;
i. Clinical findings;
ii. Diagnosis and treatment recommendations;
iii. Program activities; and
iv. General recovery and rehabilitation program
information.
4. The program administrator shall report immediately to
the Board the name of any impaired licensee who poses a
danger to self or others.
5. The program administrator shall report to the Board, as
soon as possible, the name of any impaired licensee:
a. Who refuses to submit to treatment,
b. Whose impairment is not substantially alleviated
through treatment, or
c. Who violates the terms of their contract.
6. The program administrator shall periodically provide
informational programs to the profession, including
approved continuing education programs on the topic of
drug and chemical impairment, treatment, and rehabilita-
tion.
D. Under A.R.S. § 32-1903(F), the Board may publish the names
of participants under current Board orders.
E. The Board or its executive director may request the treatment
records for any participant. The program administrator shall
provide treatment records within 10 working days of receiving
a written request from the Board or its executive director for
such records. Upon request of the program administrator or the
Board or its executive director, a program participant shall
authorize a drug and alcohol treatment facility or program or a
private practitioner or treatment program to release the partici-
pant’s records to the program administrator or the Board or its
executive director.
F. On the recommendation of the program administrator or a
Board member and by mutual consent, the program adminis-
trator, Board member, Board staff, and program participant
may meet informally to discuss program compliance.
Historical Note
New Section adopted by final rulemaking at 6 A.A.R.
467, effective January 4, 2000 (Supp. 00-1). Amended by
final rulemaking at 14 A.A.R. 3611, effective November
8, 2008 (Supp. 08-3).
R4-23-416. Reserved
R4-23-417. Reserved
R4-23-418. Reserved
R4-23-419. Reserved
R4-23-420. Reserved
R4-23-421. Repealed
Historical Note
New Section made by final rulemaking at 8 A.A.R. 4052,
effective November 9, 2002 (Supp. 02-3). Section
repealed by final rulemaking at 17 A.A.R. 2600, effective
February 4, 2012 (Supp. 11-4).
R4-23-422. Repealed
Historical Note
New Section made by final rulemaking at 8 A.A.R. 4052,
effective November 9, 2002 (Supp. 02-3). Section
repealed by final rulemaking at 17 A.A.R. 2600, effective
February 4, 2012 (Supp. 11-4).
R4-23-423. Repealed
Historical Note
New Section made by final rulemaking at 8 A.A.R. 4052,
effective November 9, 2002 (Supp. 02-3). Section
repealed by final rulemaking at 17 A.A.R. 2600, effective
February 4, 2012 (Supp. 11-4).
R4-23-424. Repealed
Historical Note
New Section made by final rulemaking at 8 A.A.R. 4052,
effective November 9, 2002 (Supp. 02-3). Section
repealed by final rulemaking at 17 A.A.R. 2600, effective
February 4, 2012 (Supp. 11-4).
R4-23-425. Repealed
Historical Note
New Section made by final rulemaking at 8 A.A.R. 4052,
effective November 9, 2002 (Supp. 02-3). Section
repealed by final rulemaking at 17 A.A.R. 2600, effective
February 4, 2012 (Supp. 11-4).
R4-23-426. Repealed
Historical Note
New Section made by final rulemaking at 8 A.A.R. 4052,
effective November 9, 2002 (Supp. 02-3). Section
repealed by final rulemaking at 17 A.A.R. 2600, effective
February 4, 2012 (Supp. 11-4).
R4-23-427. Repealed
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 34 Supp. 20-1 March 31, 2020
Historical Note
New Section made by final rulemaking at 8 A.A.R. 4052,
effective November 9, 2002 (Supp. 02-3). Section
repealed by final rulemaking at 17 A.A.R. 2600, effective
February 4, 2012 (Supp. 11-4).
R4-23-428. Repealed
Historical Note
New Section made by final rulemaking at 8 A.A.R. 4052,
effective November 9, 2002 (Supp. 02-3). Section
repealed by final rulemaking at 17 A.A.R. 2600, effective
February 4, 2012 (Supp. 11-4).
R4-23-429. Repealed
Historical Note
New Section made by final rulemaking at 8 A.A.R. 4052,
effective November 9, 2002 (Supp. 02-3). Section
repealed by final rulemaking at 17 A.A.R. 2600, effective
February 4, 2012 (Supp. 11-4).
ARTICLE 5. CONTROLLED SUBSTANCES
PRESCRIPTION MONITORING PROGRAM
New Article 5, consisting of Sections R4-23-501 through R4-
23-505, made effective August 2, 2014 (Supp. 14-2).
Article 5, consisting of Sections R4-23-501 through R4-23-
505, expired effective August 30, 2013 (Supp. 14-1).
Article 5, consisting of Sections R4-23-501 and R4-23-502,
recodified to Article 8 at 9 A.A.R. 4011, effective August 18, 2003
(Supp. 03-3).
New Article 5, consisting of Sections R4-23-501 through R4-
23-505, made by final rulemaking at 14 A.A.R. 3410, effective
October 4, 2008 (Supp. 08-3).
R4-23-501. Controlled Substances Prescription Monitoring
(CSPMP) Program Registration and Database Access
A. Under A.R.S. § 36-2606, a medical practitioner who is issued
a license under A.R.S. Title 32, Chapter 7, 11, 13, 14, 15, 16,
17, 21, 25, or 29 and possesses a current DEA registration
under the Federal Controlled Substances Act shall have a cur-
rent CSPMP registration issued by the Board.
B. Application.
1. An applicant for CSPMP registration shall:
a. Submit a completed application for CSPMP registra-
tion electronically or manually on a form furnished
by the Board, and
b. Submit with the application form the documents
specified in the application form.
2. The Board office shall deem an application form received
on the date the Board office electronically or manually
date-stamps the form.
C. Registration. Within seven business days of receipt of a com-
pleted application specified in subsection (B), the Board office
shall determine whether an application is complete. If the
application is complete, the Board office shall issue a registra-
tion number and provide a current registration certificate to the
applicant by mail or electronic transmission. If the application
is incomplete, the Board office shall issue a written notice of
incompleteness. An applicant with an incomplete application
shall comply with the requirements of R4-23-202(F).
D. Registration renewal. As specified in A.R.S. § 36-2606(C), the
Board shall automatically suspend the registration of any reg-
istrant that fails to renew the registration on or before May 1 of
the year in which the renewal is due. The Board shall vacate a
suspension if the registrant submits a renewal application. A
suspended registrant with CSPMP database access credentials
is prohibited from accessing information in the prescription
monitoring program database.
E. CSPMP database access.
1. A medical practitioner that chooses to use the CSPMP
database shall request access from the CSPMP Director
by completing an access user registration form electroni-
cally. Upon receipt of the access user registration form,
the CSPMP Director or designee shall issue access cre-
dentials provided the medical practitioner is in compli-
ance with the registration requirements of this Section.
2. A pharmacist that chooses to use the CSPMP database
shall request access from the CSPMP Director by com-
pleting an access user registration form electronically.
Upon receipt of the access user registration form, the
CSPMP Director or designee shall issue access creden-
tials provided the pharmacist has a current active pharma-
cist license.
3. A medical practitioner or pharmacist who is not licensed
in Arizona may request access from the CSPMP Director
by:
a. Completing an access user registration form elec-
tronically;
b. Printing the access user registration form;
c. Having the access user registration form signed and
notarized; and
d. Mailing the notarized access user form along with a
current copy of the applicant’s nonresident state
license and driver’s license. Upon receipt of the
notarized access user registration form and other
required documents, the CSPMP Director or desig-
nee shall issue access credentials provided the non-
resident licensed medical practitioner or pharmacist
credentials show an current active license in another
state.
Historical Note
Former Rule 5.2110; Amended effective August 9, 1983
(Supp. 83-4). Amended by final rulemaking at 8 A.A.R.
4898, effective January 5, 2003 (Supp. 02-4). Recodified
to R4-23-801 at 9 A.A.R. 4011, effective August 18,
2003 (Supp. 03-3). New Section made by final rulemak-
ing at 14 A.A.R. 3410, effective October 4, 2008 (Supp.
08-3). Amended by final rulemaking at 19 A.A.R. 94,
effective March 10, 2013 (Supp. 13-1). Section expired
under A.R.S. § 41-1056(J) at 20 A.A.R. 133, effective
August 30, 2013 (Supp. 14-1). New Section made by
final rulemaking at 20 A.A.R. 1359, effective August 2,
2014 (Supp. 14-2).
R4-23-502. Requirements for Data Format and Transmission
A. Each dispenser shall submit to the Board or its designee by
electronic means information regarding each prescription dis-
pensed for a controlled substance listed in Schedules II, III,
and IV of A.R.S. Title 36, Chapter 27, the Arizona Uniform
Controlled Substances Act. The information reported shall
conform to the August 31, 2005 Version 003, Release 000
ASAP Rules-based Standard Implementation Guide for Pre-
scription Monitoring Programs published by the American
Society for Automation in Pharmacy as specified in A.R.S. §
36-2608(B). The information submitted for each prescription
shall include:
1. The name, address, telephone number, prescription num-
ber, and DEA registration number of the dispenser;
2. The name, address, gender, date of birth, and telephone
number of the person or, if for an animal, the owner of the
animal for whom the prescription is written;
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 35
3. The name, address, telephone number, and DEA registra-
tion number of the prescribing medical practitioner;
4. The quantity and National Drug Code (NDC) number of
the Schedule II, III, or IV controlled substance dispensed;
5. The date the prescription was dispensed;
6. The number of refills, if any, authorized by the medical
practitioner;
7. The date the prescription was issued;
8. The method of payment identified as cash or third party;
and
9. Whether the prescription is new or a refill.
B. A dispenser shall submit the required information electroni-
cally unless the Board or its designee approves a waiver as
specified in subsection (D).
C. A dispenser’s electronic data transfer equipment including
hardware, software, and internet connections shall meet the
privacy and security standards of the Health Insurance Porta-
bility and Accountability Act (HIPAA) of 1996, as amended,
and A.R.S. § 12-2292, in addition to common internet industry
standards for privacy and security. A dispenser shall ensure
that each electronic transmission meets the following data pro-
tection requirements:
1. Data shall be at least 128-bit encryption in transmission
and at rest; and
2. Data shall be transmitted via secure e-mail, telephone
modem, diskette, CD-ROM, tape, secure File Transfer
Protocol (FTP), Virtual Private Network (VPN), or other
Board-approved media.
D. A dispenser who does not have an automated recordkeeping
system capable of producing an electronic report in the Board
established format may request a waiver from electronic
reporting by submitting a written request to the Board or its
designee. The Board or its designee shall grant the request if
the dispenser agrees in writing to report the data by submitting
a completed universal claim form supplied by the Board or its
designee.
E. Unless otherwise approved by the Board, a dispenser shall
report by the close of business on each Friday the required
information for the previous week, Sunday through Saturday.
If a Friday falls on a state holiday, the dispenser shall report
the information on the following business day. The Board or
its designee may approve a less frequent reporting period if a
dispenser makes a showing that a less frequent reporting
period will not reduce the effectiveness of the system or jeop-
ardize the public health.
Historical Note
Former Rule 5.2510. Amended by final rulemaking at 8
A.A.R. 4898, effective January 5, 2003 (Supp. 02-4).
Recodified to R4-23-802 at 9 A.A.R. 4011, effective
August 18, 2003 (Supp. 03-3). New Section made by
final rulemaking at 14 A.A.R. 3410, effective October 4,
2008 (Supp. 08-3). Section expired under A.R.S. § 41-
1056(J) at 20 A.A.R. 133, effective August 30, 2013
(Supp. 14-1). New Section made by final rulemaking at
20 A.A.R. 1359, effective August 2, 2014 (Supp. 14-2).
R4-23-503. Access to Controlled Substances Prescription
Monitoring Program Data
A. Except as provided in A.R.S. § 36-2604(B) and (C) and this
Section, prescription information submitted to the Board or its
designee is confidential and is not subject to public inspection.
B. The Board or its designee shall review the prescription infor-
mation collected under A.R.S. Title 36, Chapter 28 and R4-23-
502. If the Board or its designee has reason to believe an act of
unprofessional or illegal conduct has occurred, the Board or its
designee shall notify the appropriate professional licensing
board or law enforcement or criminal justice agency and pro-
vide the prescription information required for an investigation.
C. The Board or its designee is authorized to release data col-
lected by the program to the following:
1. A person who is authorized to prescribe or dispense a
controlled substance to assist that person to provide med-
ical or pharmaceutical care to a patient or to evaluate a
patient;
2. An individual who requests the individual’s own con-
trolled substance prescription information under A.R.S. §
12-2293;
3. A professional licensing board established under A.R.S.
Title 32, Chapter 7, 11, 13, 14, 15, 16, 17, 18, 21, 25, or
29. Except as required under subsection (B), the Board or
its designee shall provide this information only if the
requesting board states in writing that the information is
necessary for an open investigation or complaint;
4. A local, state, or federal law enforcement or criminal jus-
tice agency. Except as required under subsection (B), the
Board or its designee shall provide this information only
if the requesting agency states in writing that the informa-
tion is necessary for an open investigation or complaint;
5. The Arizona Health Care Cost Containment System
Administration regarding individuals who are receiving
services under A.R.S. Title 36, Chapter 29. Except as
required under subsection (B), the Board or its designee
shall provide this information only if the Administration
states in writing that the information is necessary for an
open investigation or complaint;
6. A person serving a lawful order of a court of competent
jurisdiction;
7. A person who is authorized to prescribe or dispense a
controlled substance and who performs an evaluation on
an individual under A.R.S. § 23-1026; and
8. The Board staff for purposes of administration and
enforcement of A.R.S. Title 36, Chapter 28 and this Arti-
cle.
D. The Board or its designee may provide data to public or pri-
vate entities for statistical, research, or educational purposes
after removing information that could be used to identify indi-
vidual patients or persons who received prescriptions from dis-
pensers.
Historical Note
Former Rules 5.3500, 5.3520, 5.3540, 5.3550, 5.3560,
5.3570, 5.3580, 5.3590, 5.4110, and 5.6110; Repealed
effective August 2, 1982 (Supp. 82-4). New Section made
by final rulemaking at 14 A.A.R. 3410, effective October
4, 2008 (Supp. 08-3). Section expired under A.R.S. § 41-
1056(J) at 20 A.A.R. 133, effective August 30, 2013
(Supp. 14-1). New Section made by final rulemaking at
20 A.A.R. 1359, effective August 2, 2014 (Supp. 14-2).
R4-23-504. Computerized Central Database Tracking Sys-
tem Task Force
A. The Board shall appoint a task force to help it administer the
computerized central database tracking system as specified in
A.R.S. § 36-2603.
B. The Task Force shall meet at least once each year and at the
call of the chairperson to establish the procedures and condi-
tions relating to the release of prescription information speci-
fied in A.R.S. § 36-2604 and R4-23-503.
C. The Task Force shall determine:
1. The information to be screened;
2. The frequency and thresholds for screening; and
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 36 Supp. 20-1 March 31, 2020
3. The parameters for using the information to notify medi-
cal practitioners, patients, and pharmacies to educate and
provide for patient management and treatment options.
D. The Board shall review and approve the procedures and condi-
tions established by the Task Force as needed but at least once
every calendar year.
Historical Note
Former Rule 5.7010; Amended effective August 10, 1978
(Supp. 78-4). Repealed effective August 2, 1982
(Supp. 82-4). New Section made by final rulemaking at
14 A.A.R. 3410, effective October 4, 2008 (Supp. 08-3).
Section expired under A.R.S. § 41-1056(J) at 20 A.A.R.
133, effective August 30, 2013 (Supp. 14-1). New Sec-
tion made by final rulemaking at 20 A.A.R. 1359, effec-
tive August 2, 2014 (Supp. 14-2).
R4-23-505. Reports
A. Before releasing prescription monitoring program data, the
Board or its designee shall receive a written or electronic
request for controlled substance prescription information.
B. A person authorized to access CSPMP data under R4-23-
503(C)(1) through (7) shall submit a written or electronic
request that:
1. Specifies the information requested for the report;
2. For a medical practitioner, provides a statement that the
report’s purpose is to provide medical or pharmaceutical
care to a patient or to evaluate a patient;
3. For an individual obtaining the individual’s own con-
trolled substance prescription information, provides a
form of non-expired government-issued photo identifica-
tion;
4. For a professional licensing board, states that the infor-
mation is necessary for an open investigation or com-
plaint;
5. For a local, state, or federal law enforcement or criminal
justice agency, states that the information is necessary for
an open investigation or complaint;
6. For the AHCCCS Administration, states that the informa-
tion is necessary for an open investigation or complaint;
and
7. For a person serving a lawful order of a court of compe-
tent jurisdiction, provides a copy of the court order.
C. The Board or its designee may provide reports through U.S.
mail, other common carrier, facsimile, or secured electronic
media or may allow reports to be picked up in-person at the
Board office.
Historical Note
Former Rules 5.7100, 5.8100, 5.8500, 5.9100, and
5.9500; Amended effective August 10, 1978 (Supp. 78-
4). Repealed effective August 2, 1982 (Supp. 82-4). New
Section made by final rulemaking at 14 A.A.R. 3410,
effective October 4, 2008 (Supp. 08-3). Section expired
under A.R.S. § 41-1056(J) at 20 A.A.R. 133, effective
August 30, 2013 (Supp. 14-1). New Section made by
final rulemaking at 20 A.A.R. 1359, effective August 2,
2014 (Supp. 14-2).
R4-23-506. Repealed
Historical Note
Adopted effective December 3, 1974 (Supp. 75-1).
Repealed effective August 24, 1992 (Supp. 92-3).
ARTICLE 6. PERMITS AND DISTRIBUTION OF DRUGS
R4-23-601. General Provisions
A. Permit required to sell a narcotic or other controlled substance,
prescription-only drug or device, nonprescription drug, precur-
sor chemical, or regulated chemical. A person shall have a cur-
rent Board permit to:
1. Sell a narcotic or other controlled substance, prescription-
only drug or device, nonprescription drug, precursor
chemical, or regulated chemical in Arizona; or
2. Sell a narcotic or other controlled substance, prescription-
only drug or device, nonprescription drug, precursor
chemical, or regulated chemical from outside Arizona
and ship the narcotic or other controlled substance, pre-
scription-only drug or device, nonprescription drug, pre-
cursor chemical, or regulated chemical into Arizona.
B. A medical practitioner is exempt from subsection (A) to
administer a narcotic or other controlled substance, prescrip-
tion-only drug or device, nonprescription drug, precursor
chemical, or regulated chemical for the emergency needs of a
patient.
C. Permit fee. Permits are issued biennially on an odd- and even-
year expiration based on the assigned permit number. The fee,
specified in R4-23-205, is not refundable unless the Board
fails to comply with the permit time frames established in R4-
23-602.
D. Record of receipt and disposal of narcotics or other controlled
substances, prescription-only drugs or devices, nonprescrip-
tion drugs, precursor chemicals, or regulated chemicals.
1. Every person manufacturing a narcotic or other con-
trolled substance, prescription-only drug or device, non-
prescription drug, precursor chemical, or regulated
chemical, including repackaging or relabeling, shall pre-
pare and retain for no fewer than three years the manufac-
turing, repackaging, or relabeling date for each narcotic
or other controlled substance, prescription-only drug or
device, nonprescription drug, precursor chemical, or reg-
ulated chemical.
2. Every person receiving, selling, delivering, or disposing
of a narcotic or other controlled substance, prescription-
only drug or device, nonprescription drug, precursor
chemical, or regulated chemical shall record and retain
for no fewer than three years the following information:
a. The name, strength, dosage form, and quantity of
each narcotic or other controlled substance, pre-
scription-only drug or device, nonprescription drug,
precursor chemical, or regulated chemical received,
sold, delivered, or disposed;
b. The name, address, and license or permit number, if
applicable, of the person from whom each narcotic
or other controlled substance, prescription-only drug
or device, nonprescription drug, precursor chemical,
or regulated chemical is received;
c. The name, address, and license or permit number, if
applicable, of the person to whom each narcotic or
other controlled substance, prescription-only drug or
device, nonprescription drug, precursor chemical, or
regulated chemical is sold or delivered, or of the per-
son who disposes of each narcotic or other con-
trolled substance, prescription-only drug or device,
nonprescription drug, precursor chemical, or regu-
lated chemical; and
d. The receipt, sale, deliver, or disposal date of each
narcotic or other controlled substance, prescription-
only drug or device, nonprescription drug, precursor
chemical, or regulated chemical.
3. The record required in this subsection shall be available
for inspection by the Board or its compliance officer
during regular business hours.
4. If the record required in this subsection is stored in a cen-
tralized recordkeeping system and not immediately avail-
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 37
able for inspection, a permittee, manager, or pharmacist-
in-charge shall provide the record within four working
days of the Board’s or its compliance officer’s request.
E. Narcotics or other controlled substances, prescription-only
drugs or devices, nonprescription drugs, precursor chemicals,
or regulated chemicals damaged by water, fire, or from human
or animal consumption or use. A person shall not sell or offer
to sell any narcotic or other controlled substance, prescription-
only drug or device, nonprescription drug, precursor chemical,
or regulated chemical damaged by water, fire, or from human
or animal consumption or use.
F. At least 14 days before there is a change in ownership, as
defined at R4-23-110, of a license or permit issued under this
Chapter, the new licensee or permittee shall apply to the Board
for a new license or permit.
Historical Note
Former Rules 6.1100, 6.1200, 6.1300, 6.1400, and
6.1500. Amended effective August 10, 1978 (Supp. 78-
4). Amended subsection (C) effective August 9, 1983
(Supp. 83-4). Amended subsection (C) effective August
12, 1988 (Supp. 88-3). Amended by final rulemaking at 6
A.A.R. 4656, effective November 14, 2000 (Supp. 00-4).
Amended by final rulemaking at 12 A.A.R. 1912, effec-
tive July 1, 2006 (Supp. 06-2). Amended by final
rulemaking at 14 A.A.R. 3670, effective November 8,
2008 (Supp. 08-3). Amended by final rulemaking at 25
A.A.R. 1015, effective June 1, 2019 (Supp. 19-2).
R4-23-602. Permit Application Process and Time frames
A. A person applying for a permit shall:
1. Submit a completed application for the desired permit
electronically or manually on a form furnished by the
Board, and
2. Submit with the application form:
a. The documents specified in the application form,
and
b. The permit fee specified in R4-23-205.
B. The Board office shall deem an application form received on
the date the Board office electronically or manually date-
stamps the form.
C. Time frames for permits.
1. The Board office shall finish an administrative complete-
ness review within 60 days from the date the application
form is received.
a. The Board office shall issue a written notice of
administrative completeness to the applicant if no
deficiencies are found in the application form.
b. If the application form is incomplete, the Board
office shall provide the applicant with a written
notice that includes a comprehensive list of the miss-
ing information. The 60-day time frame for the
Board office to finish the administrative complete-
ness review is suspended from the date the notice of
incompleteness is served until the applicant provides
the Board office with all missing information.
c. If the Board office does not provide the applicant
with written notice regarding administrative com-
pleteness, the application form shall be deemed
complete 60 days after receipt by the Board office.
2. An applicant with an incomplete application form shall
submit to the Board office all of the missing information
within 90 days of service of the notice of incompleteness.
a. If an applicant cannot submit all missing informa-
tion within 90 days of service of the notice of incom-
pleteness, the applicant may send a written request
for an extension to the Board office postmarked or
delivered no later than 90 days from service of the
notice of incompleteness;
b. The written request for an extension shall document
the reasons the applicant is unable to meet the 90-
day deadline; and
c. The Board office shall review the request for an
extension of the 90-day deadline and grant the
request if the Board office determines an extension
of the 90-day deadline will enable the applicant to
assemble and submit the missing information. An
extension shall be for no more than 30 days. The
Board office shall notify the applicant in writing of
its decision to grant or deny the request for an exten-
sion.
3. If an applicant fails to submit a complete application form
within the time allowed, the Board office shall close the
applicant’s file. An applicant whose file is closed and
who later wishes to obtain a permit shall submit a new
application and fee as specified in subsection (A).
4. For a nonprescription drug permit applicant, a com-
pressed medical gas distributor permit applicant, and a
durable medical equipment and compressed medical gas
supplier permit applicant, the Board office shall issue a
permit on the day the Board office determines an admin-
istratively complete application form is received.
5. Except as described in subsection (C)(4), from the date
on which the administrative completeness review of an
application form is finished, the Board office shall com-
plete a substantive review of the applicant’s qualifications
in no more than 120 days.
a. If an applicant is found to be ineligible, the Board
office shall issue a written notice of denial to the
applicant.
b. If an applicant is found to be eligible, the Board
office shall recommend to the Board that the appli-
cant be issued a permit. Upon receipt of the Board
office’s recommendation, the Board shall either
issue a permit to the applicant or if the Board deter-
mines the applicant does not meet eligibility require-
ments, return the matter to the Board office.
c. If the Board office finds deficiencies during the sub-
stantive review of the application form, the Board
office shall issue a written request to the applicant
for additional documentation.
d. The 120-day time frame for a substantive review for
the issuance or denial of a permit is suspended from
the date of the written request for additional docu-
mentation until the date all documentation is
received. The applicant shall submit the additional
documentation according to subsection (C)(2).
e. If the applicant and the Board office mutually agree
in writing, the 120-day substantive review time
frame may be extended once for no more than 45
days.
6. For the purpose of A.R.S. § 41-1072 et seq., the Board
establishes the following time frames for permits:
a. Administrative completeness review time frame: 60
days.
b. Substantive review time frame:
i. Nonprescription drug permit, compressed med-
ical gas distributor permit, and durable medical
equipment and compressed medical gas sup-
plier permit: none.
ii. Except as described in subsection (C)(6)(b)(i):
120 days.
c. Overall time frame:
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 38 Supp. 20-1 March 31, 2020
i. Nonprescription drug permit, compressed med-
ical gas distributor permit, and durable medical
equipment and compressed medical gas sup-
plier permit: 60 days.
ii. Except as described in subsection (C)(6)(c)(i):
180 days.
D. Permit renewal.
1. To renew a permit, a permittee shall submit a completed
application for permit renewal electronically or manually
on a form furnished by the Board with the biennial
renewal fee specified in R4-23-205.
2. If the biennial renewal fee is not paid by November 1 of
the renewal year specified in A.R.S. § 32-1931, the per-
mit is suspended. The permittee shall pay a penalty as
provided in A.R.S. § 32-1931 and R4-23-205 to vacate
the suspension.
3. Time frames for permit renewals. The Board office shall
follow the time frames established in subsection (C).
E. Display of permit. A permittee shall conspicuously display the
permit in the location to which it applies.
Historical Note
Former Rules 6.2100, 6.2200, 6.2300, 6.2400, 6.2500,
6.2600, 6.2610, 6.2620, 6.2630, 6.2640, and 6.2650.
Amended effective August 10, 1978 (Supp. 78-4).
Amended effective August 9, 1983 (Supp. 83-4).
Repealed effective August 12, 1988 (Supp. 88-3). New
Section adopted effective August 5, 1997 (Supp. 97-3).
Amended by final rulemaking at 6 A.A.R. 4589, effective
November 14, 2000 (Supp. 00-4). Amended by final
rulemaking at 20 A.A.R. 1364, effective August 2, 2014
(Supp. 14-2). Amended by final rulemaking at 25 A.A.R.
1015, effective June 1, 2019 (Supp. 19-2).
R4-23-603. Resident-Nonprescription Drugs, Retail
A. Permit. A person, including the following, shall not sell or dis-
tribute a nonprescription drug without a current Board-issued
permit:
1. A grocer;
2. Other non-pharmacy retail outlet; or
3. Mobile or non-fixed location retailer, such as a swap-
meet vendor.
B. A medical practitioner licensed under A.R.S. Title 32 is
exempt from the requirements of subsection (A).
C. Application. To obtain a permit to sell a nonprescription drug,
a person shall submit:
1. A completed application form and fee as specified in R4-
23-602; and
2. Documentation of compliance with local zoning laws, if
required by the Board.
D. Drug sales. A nonprescription drug permittee:
1. Shall sell a drug only in the original container packaged
and labeled by the manufacturer; and
2. Shall not package, repackage, label, or relabel any drug.
E. Inspection. A nonprescription drug permittee shall consent to
inspection during business hours by a Board compliance offi-
cer or other authorized officer of the law as defined in A.R.S. §
32-1901.
F. Quality control. A nonprescription drug permittee shall:
1. Ensure that all drugs stocked, sold, or offered for sale are:
a. Kept clean;
b. Protected from contamination, excessive heat, cold,
sunlight, and other deteriorating factors;
c. In compliance with federal law; and
d. Received from a supplier with a current Board-
issued permit as specified in R4-23-601(A).
2. Develop and implement a program to ensure that:
a. Any expiration-dated drug is reviewed regularly;
b. Any drug, that exceeds its expiration date, is deterio-
rated or damaged, or does not comply with federal
law, is moved to a quarantine area and not sold or
distributed; and
c. Any quarantined drug is destroyed or returned to its
source of supply.
G. Notification. A nonprescription drug permittee shall submit
using the permittee’s online profile or provide written notice
by mail, fax, or e-mail to the Board office within 10 days of
changes involving the telephone or fax number, e-mail or
mailing address, or business name.
H. Change of ownership. A nonprescription drug permittee shall
comply with R4-23-601(F).
I. Relocation. No less than 30 days before an existing nonpre-
scription drug permittee relocates, the permittee shall submit a
completed application for relocation electronically or manu-
ally on a form furnished by the Board, and the documentation
required in subsection (C).
J. Records. A nonprescription drug permittee shall:
1. Retain records of the receipt and disposal of nonprescrip-
tion drugs as required in R4-23-601(D), and
2. Comply with the requirements of A.R.S. § 32-1977 and
federal law for the retail sale of methamphetamine pre-
cursors.
K. Permit renewal. To renew a nonprescription drug permit, the
permittee shall comply with R4-23-602(D).
L. Nonprescription drug vending machine outlet. In addition to
the requirements of R4-23-601, R4-23-602, and subsections
(A) through (K), a person selling or distributing a nonprescrip-
tion drug in a vending machine shall comply with the follow-
ing requirements:
1. Each individual vending machine is considered an outlet
and shall have a Board-issued nonprescription drug per-
mit;
2. Each nonprescription-drug-permitted vending machine
shall display in public view an identification seal, fur-
nished by the Board, containing the permit number, vend-
ing machine’s serial number, owner’s name, and
telephone contact number;
3. Each nonprescription-drug-permitted vending machine is
assigned a specific location that is within a weather-tight
structure, protected from direct sunlight, and maintained
at a temperature not less than 59° F and not greater than
86° F;
4. Each nonprescription drug sold in a vending machine is
packaged and labeled in the manufacturer’s original
FDA-approved container;
5. A nonprescription-drug-permitted vending machine is
subject to inspection by a Board compliance officer or
other authorized officer of the law as defined in A.R.S. §
32-1901 as follows:
a. The owner, manager, or other staff of the nonpre-
scription drug permittee shall provide access to the
contents of the vending machine within 24 hours of
a request from a Board compliance officer or other
authorized officer of the law; or
b. The Board compliance staff shall have independent
access to the vending machine;
6. Before relocating or retiring a nonprescription-drug-per-
mitted vending machine, the owner or manager shall
notify the Board in writing. The notice shall include:
a. Permit number;
b. Vending machine’s serial number;
c. Action planned (relocate or retire); and
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 39
d. If retiring a vending machine, the disposition of the
nonprescription drug contents of the vending
machine;
7. The sale or distribution of a precursor chemical or regu-
lated chemical in a vending machine is prohibited; and
8. Under no circumstance may expired drugs be sold or dis-
tributed.
Historical Note
Adopted effective August 10, 1978 (Supp. 78-4).
Amended subsection (D) paragraph (1) and added sub-
section (G) effective April 20, 1982 (Supp. 82-2).
Amended effective August 12, 1988 (Supp. 88-3).
Amended effective February 8, 1991 (Supp. 91-1).
Amended effective August 5, 1997 (Supp. 97-3).
Amended by final rulemaking at 6 A.A.R. 4589, effective
November 14, 2000 (Supp. 00-4). Amended by final
rulemaking at 20 A.A.R. 1364, effective August 2, 2014
(Supp. 14-2). Amended by final rulemaking at 25 A.A.R.
1015, effective June 1, 2019 (Supp. 19-2).
R4-23-604. Resident Drug Manufacturer
A. Permit. A person shall not manufacture, package, repackage,
label, or relabel any narcotic or other controlled substance,
prescription-only drug or device, nonprescription drug, precur-
sor chemical, or regulated chemical without a current Board-
issued drug manufacturer permit.
B. Application. To obtain a permit to operate a drug manufactur-
ing firm in Arizona, a person shall submit a completed appli-
cation, on a form furnished by the Board, and the fee specified
in R4-23-205.
C. Before issuing a drug manufacturer permit, the Board shall:
1. Receive and approve a completed permit application;
2. Interview the applicant and manager, if different from the
applicant, at a Board meeting; and
3. Receive a satisfactory compliance inspection report on
the facility from a Board compliance officer.
D. Notification. A resident drug manufacturer permittee shall
notify the Board of changes involving the drug list, address,
telephone number, business name, or manager, including man-
ager’s telephone number. The resident drug manufacturer per-
mittee shall submit using the permittee’s online profile or a
written notice by mail, fax, or e-mail to the Board office within
24 hours of the change.
E. Change of ownership. A resident drug manufacturer permittee
shall comply with R4-23-601(F).
F. Before an existing resident drug manufacturer permittee relo-
cates, the drug manufacturer permittee shall submit the appli-
cation packet described in subsection R4-23-604(B),
excluding the fee. The facility at the new location shall pass a
final inspection by a Board compliance officer before opera-
tions begin.
G. No later than 14 days after the change occurs, a resident drug
manufacturer permittee shall submit the application described
under subsection R4-23-604(B), excluding the fee, for any
change of officers in a corporation.
H. Manufacturing and distribution.
1. A drug manufacturer permittee shall manufacture and
distribute a drug only:
a. To a pharmacy, drug manufacturer, or full-service or
nonprescription drug wholesaler currently permitted
by the Board;
b. To a medical practitioner currently licensed as a
medical practitioner as defined in A.R.S. § 32-1901;
or
c. To a properly permitted, registered, licensed, or cer-
tified person or firm of another jurisdiction.
2. Before manufacturing and distributing a drug that is not
listed on a drug manufacturer’s permit application, the
drug manufacturer permittee shall send to the Board
office a written request to amend the permit application,
including documentation of FDA approval to manufac-
ture the drug not listed on the original permit application.
If a request to amend a permit application includes the
documentation required in this subsection, the Board or
its designee shall approve the request to amend within 30
days of receipt.
I. A drug manufacturer permit is subject to denial, suspension,
probation, or revocation under A.R.S. § 32-1927.02.
J. Current Good Manufacturing Practice. A drug manufacturer
permittee is required under federal law to follow the good
manufacturing practice requirements of 21 CFR 210 through
211.
K. Records. A drug manufacturer permittee shall:
1. Establish and implement written procedures for maintain-
ing records pertaining to production, process control,
labeling, packaging, quality control, distribution, com-
plaints, and any information required by federal or state
law;
2. Retain the records required by this Article and 21 CFR
210 through 211 for at least two years after distribution of
a drug or one year after the expiration date of a drug,
whichever is longer; and
3. Make the records required by this Article and 21 CFR
210 through 211 available within 48 hours for review by
a Board compliance officer or other authorized officer of
the law as defined in A.R.S. § 32-1901.
L. Inspections. A drug manufacturer permittee shall make the
drug manufacturer’s facility available for inspection by the
Board or its compliance officer under A.R.S. § 32-1904.
M. Nonresident drug manufacturer. A nonresident drug manufac-
turer shall comply with the requirements of R4-23-607.
N. Manufacturing radiopharmaceuticals. Before manufacturing a
radiopharmaceutical, a drug manufacturer permittee shall:
1. Comply with the regulatory requirements of the Arizona
Radiation Regulatory Agency, the U.S. Nuclear Regula-
tory Commission, the FDA, and this Section; and
2. Hold a current Arizona Radiation Regulatory Agency
Radioactive Materials License. If a drug manufacturer
permittee who manufactures radiopharmaceuticals fails
to maintain a current Arizona Radiation Regulatory
Agency Radioactive Materials License, the permittee’s
drug manufacturer permit shall be immediately sus-
pended pending a hearing by the Board.
Historical Note
Former Rules 6.4001, 6.4002, 6.4003, 6.4004, 6.4005,
6.4006, 6.4007, 6.4008, 6.4009, 6.4100, 6.4110, 6.4111,
6.4115, 6.4116, 6.4120, 6.4122, 6.4190, 6.4191, 6.4200,
6.4250, 6.4300, 6.4350, 6.4355, 6.4360, 6.4400, 6.4401,
6.4403, 6.4410, 6.4430, 6.4450, 6.4500, 6.4510, 6.4530,
6.4533, 6.4600, 6.4610, 6.4640, 6.4660, 6.4700, 6.4710,
and 6.4750. Adopted effective December 3, 1974 (Supp.
75-1). Amended effective August 10, 1978 (Supp. 78-4).
Amended subsection (B) paragraph (2) effective April 20,
1982 (Supp. 82-2). Amended subsections (B), (G), (K)
and (L) effective August 12, 1988 (Supp. 88-3).
Amended effective August 24, 1992 (Supp. 92-3).
Amended effective November 1, 1993 (Supp. 93-4).
Amended by final rulemaking at 7 A.A.R. 3815, effective
August 9, 2001 (Supp. 01-3). Amended by final rulemak-
ing at 11 A.A.R. 1105, effective April 30, 2005 (Supp.
05-1). Amended by final rulemaking at 19 A.A.R. 702,
effective June 1, 2013 (Supp. 13-2). Amended by final
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 40 Supp. 20-1 March 31, 2020
rulemaking at 25 A.A.R. 1015, effective June 1, 2019
(Supp. 19-2).
R4-23-605. Resident Drug Wholesaler Permit
A. Permit. A person shall not operate a business or firm for the
wholesale distribution of any drug, device, precursor chemi-
cal, or regulated chemical without a current Board-issued full-
service or nonprescription drug wholesale permit.
B. Application.
1. To obtain a permit to operate a full-service or nonpre-
scription drug wholesale firm in Arizona, a person shall
submit a completed application, on a form furnished by
the Board, and the fee specified in R4-23-205.
2. Before issuing a full-service or nonprescription drug
wholesale permit, the Board shall:
a. Receive and approve a completed permit applica-
tion;
b. Interview the applicant and the designated represen-
tative, if different from the applicant, at a Board
meeting;
c. Receive a satisfactory compliance inspection report
on the facility from a Board compliance officer; and
d. For a full-service drug wholesale permit, issue a fin-
gerprint clearance to a qualified designated repre-
sentative, as specified in subsection (L). If the
fingerprint clearance of a designated representative
for a full-service drug wholesale permit applicant is
denied, the full-service drug wholesale permit appli-
cant shall appoint another designated representative
and submit the documentation, fingerprints, and fee
specified in the application required in subsection
(B).
C. Notification. A resident full-service or nonprescription drug
wholesale permittee shall notify the Board of changes involv-
ing the type of drugs sold or distributed, address, telephone
number, business name, or manager or designated representa-
tive, including the manager’s or designated representative’s
telephone number.
1. The resident full-service or nonprescription drug whole-
sale permittee shall submit using the permittee’s online
profile or a written notice by mail, fax, or e-mail to the
Board office within 10 days of the change.
2. For a change of designated representative, a resident full-
service drug wholesale permittee shall submit the docu-
mentation, fingerprints, and fee specified in the applica-
tion required in subsection (B).
D. Change of ownership. A resident full-service or nonprescrip-
tion drug wholesale permittee shall comply with R4-23-
601(F).
E. Before an existing resident full-service or nonprescription
drug wholesaler permittee relocates, the resident full-service
or nonprescription drug wholesale permittee shall submit the
application required under subsection (B), excluding the fee.
The facility at the new location shall pass a final inspection by
a Board compliance officer before operations begin.
F. No later than 14 days after the change occurs, a resident full-
service or nonprescription drug wholesale permittee shall sub-
mit the application described under subsection (B), excluding
the fee, for any change of officers in a corporation.
G. Distribution restrictions. In addition to the requirements of this
subsection, a resident full-service wholesale permittee shall
comply with the distribution restrictions specified in A.R.S. §
32-1983.
1. Records.
a. A full-service drug wholesale permittee shall:
i. Maintain records to ensure full accountability
of any narcotic or other controlled substance,
prescription-only drug or device, nonprescrip-
tion drug, precursor chemical, or regulated
chemical including dates of receipt and sales,
names, addresses, and DEA registration num-
bers, if required, of suppliers or sources of mer-
chandise, and customer names, addresses, and
DEA registration numbers, if required;
ii. File the records required in subsection
(G)(1)(a)(i) in a readily retrievable manner for
a minimum of three years;
iii. Make the records required in subsection
(G)(1)(a)(i) available upon request during regu-
lar business hours for inspection by a Board
compliance officer or other authorized officer
of the law as defined in A.R.S. § 32-1901(5).
Records kept at a central location apart from
the business location and not electronically
retrievable shall be made available within two
business days; and
iv. In addition to the records requirements of sub-
section (G)(1)(a)(i), comply with the retention
of track and trace documents required under the
Drug Supply Chain and Security Act for all
prescription-only drugs that leave the normal
distribution channel as defined in A.R.S. § 32-
1981.
b. A nonprescription drug wholesale permittee shall:
i. Maintain records to ensure full accountability
of any nonprescription drug, precursor chemi-
cal, or regulated chemical including dates of
receipt and sales, names, addresses, and DEA
registration numbers, if required, of suppliers
or sources of merchandise, and customer
names, addresses, and DEA registration num-
bers, if required;
ii. File the records required in subsection
(G)(1)(b)(i) in a readily retrievable manner for
a minimum of three years; and
iii. Make the records required in subsection
(G)(1)(b)(i) available upon request during regu-
lar business hours for inspection by a Board
compliance officer or other authorized officer
of the law as defined in A.R.S. § 32-1901(5).
Records kept at a central location apart from
the business location and not electronically
retrievable shall be made available within two
business days.
2. Drug sales.
a. A full-service drug wholesale permittee shall:
i. Not sell, distribute, give away, or dispose of
any narcotic or other controlled substance, pre-
scription-only drug or device, nonprescription
drug, precursor chemical, or regulated chemi-
cal, except in the original container packaged
and labeled by the manufacturer or repackager;
ii. Not package, repackage, label, or relabel any
narcotic or other controlled substance, prescrip-
tion-only drug or device, nonprescription drug,
precursor chemical, or regulated chemical;
iii. Not sell, distribute, give away, or dispose of
any narcotic or other controlled substance, or
prescription-only drug or device, to anyone
except a pharmacy, drug manufacturer, or full-
service drug wholesaler currently permitted by
the Board or a medical practitioner currently
licensed under A.R.S. Title 32;
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 41
iv. Not sell, distribute, give away, or dispose of
any nonprescription drug, precursor chemical,
or regulated chemical, to anyone except a phar-
macy, drug manufacturer, full-service or non-
prescription drug wholesaler, or
nonprescription drug retailer currently permit-
ted by the Board or a medical practitioner cur-
rently licensed under A.R.S. Title 32;
v. Provide track and trace documents required
under the Drug Supply Chain and Security Act
upon request, if immediately available, or
within two business days from the date of a
request of a Board compliance officer or other
authorized officer of the law as defined in
A.R.S. § 32-1901;
vi. Maintain a copy of the current permit or license
of each person that buys, receives, or disposes
of any narcotic or other controlled substance,
prescription-only drug or device, nonprescrip-
tion drug, precursor chemical, or regulated
chemical; and
vii. Provide permit and license records upon
request, if immediately available, or within two
business days from the date of the request of a
Board compliance officer or other authorized
officer of the law as defined in A.R.S. § 32-
1901(5).
b. A nonprescription drug wholesale permittee shall:
i. Not sell, distribute, give away, or dispose of
any nonprescription drug, precursor chemical,
or regulated chemical except in the original
container packaged and labeled by the manu-
facturer or repackager;
ii. ii. Not package, repackage, label, or relabel any
nonprescription drug, precursor chemical, or
regulated chemical;
iii. Not sell or distribute any nonprescription drug,
precursor chemical, or regulated chemical to
anyone except a pharmacy, drug manufacturer,
full-service or nonprescription drug wholesaler,
or nonprescription drug retailer currently per-
mitted by the Board or a medical practitioner
currently licensed under A.R.S. Title 32;
iv. Maintain a record of the current permit or
license of each person that buys, receives, or
disposes of any nonprescription drug, precursor
chemical, or regulated chemical; and
v. Provide permit and license records upon
request, if immediately available, or within two
business days from the date of the request of a
Board compliance officer or other authorized
officer of the law as defined in A.R.S. § 32-
1901(5).
c. Nothing in this subsection shall be construed to pre-
vent the return of a narcotic or other controlled sub-
stance, prescription-only drug or device,
nonprescription drug, precursor chemical, or regu-
lated chemical to the original source of supply.
3. Out-of-state drug sales.
a. A full-service drug wholesale permittee shall:
i. Not sell, distribute, give away, or dispose of
any narcotic or other controlled substance, pre-
scription-only drug or device, nonprescription
drug, precursor chemical, or regulated chemical
except in the original container packaged and
labeled by the manufacturer or repackager;
ii. Not package, repackage, label, or relabel any
narcotic or other controlled substance, prescrip-
tion-only drug or device, nonprescription drug,
precursor chemical, or regulated chemical;
iii. Not sell, distribute, give away, or dispose of
any narcotic or other controlled substance, pre-
scription-only drug or device, nonprescription
drug, precursor chemical, or regulated chemical
to anyone except a person that is properly per-
mitted, registered, licensed, or certified in
another jurisdiction;
iv. Provide track and trace documents required
under the Drug Supply Chain and Security Act
upon request, if immediately available, or
within two business days from the date of the
request of a Board compliance officer or other
authorized officer of the law as defined in
A.R.S. § 32-1901;
v. Maintain a copy of the current permit, registra-
tion, license, or certificate of each person that
buys, receives, or disposes of any narcotic or
other controlled substance, prescription-only
drug or device, nonprescription drug, precursor
chemical, or regulated chemical; and
vi. Provide permit, registration, license, and certif-
icate records upon request, if immediately
available, or within two business days from the
date of the request of a Board compliance offi-
cer or other authorized officer of the law as
defined in A.R.S. § 32-1901(5); and
b. A nonprescription drug wholesale permittee shall:
i. Not sell, distribute, give away, or dispose of
any nonprescription drug, precursor chemical,
or regulated chemical except in the original
container packaged and labeled by the manu-
facturer or repackager;
ii. Not package, repackage, label, or relabel any
nonprescription drug, precursor chemical, or
regulated chemical;
iii. Not sell or distribute any nonprescription drug,
precursor chemical, or regulated chemical to
anyone except a person that is properly permit-
ted, registered, licensed, or certified in another
jurisdiction;
iv. Maintain a record of the current permit, regis-
tration, license, or certificate of each person
that buys, receives, or disposes of any nonpre-
scription drug, precursor chemical, or regulated
chemical; and
v. Provide permit, registration, license, or certifi-
cate records upon request, if immediately avail-
able, or within two business days from the date
of the request of a Board compliance officer or
other authorized officer of the law as defined in
A.R.S. § 32-1901(5).
4. Cash-and-carry sales.
a. A full-service drug wholesale permittee shall com-
plete a cash-and-carry sale or distribution of any nar-
cotic or other controlled substance, prescription-
only drug or device, nonprescription drug, precursor
chemical, or regulated chemical only after:
i. Verifying the validity of the order;
ii. Verifying the identity of the pick-up person for
each transaction by confirming that the person
represented placed the cash-and-carry order;
and
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 42 Supp. 20-1 March 31, 2020
iii. For a prescription-only drug order, verifying
that the cash-and-carry sale or distribution is
used only to meet the immediate needs of a par-
ticular patient of the person that placed the
cash-and-carry order; and
b. A nonprescription drug wholesale permittee shall
complete a cash-and-carry sale or distribution of any
nonprescription drug, precursor chemical, or regu-
lated chemical only after:
i. Verifying the validity of the order; and
ii. Verifying the identity of the pick-up person for
each transaction by confirming that the person
represented placed the cash-and-carry order.
H. Prescription-only drug returns or exchanges. A full-service
drug wholesale permittee shall ensure that any prescription-
only drug returned or exchanged by a pharmacy or chain phar-
macy warehouse under A.R.S. § 32-1983(A) meets the follow-
ing criteria:
1. The prescription-only drug is not adulterated or counter-
feited, except an adulterated or counterfeited prescrip-
tion-only drug that is the subject of an FDA or
manufacturer recall may be returned for destruction or
subsequent return to the manufacturer;
2. The quantity of prescription-only drug returned or
exchanged does not exceed the quantity of prescription-
only drug that the full-service drug wholesale permittee
or a full-service drug wholesale permittee under common
ownership sold to the pharmacy or chain pharmacy ware-
house; and
3. The pharmacy or chain pharmacy warehouse provides
documentation that:
a. Lists the name, strength, and manufacturer of the
prescription-only drug being returned or exchanged;
and
b. States that the prescription-only drug was main-
tained in compliance with storage conditions pre-
scribed on the drug label or manufacturer’s package
insert.
I. Returned, outdated, damaged, deteriorated, adulterated, mis-
branded, counterfeited, and contraband drugs.
1. Except as specified in subsection (H)(1) for a prescrip-
tion-only drug, a full-service drug wholesale permittee
shall ensure that the return of any narcotic or other con-
trolled substance, prescription-only drug or device, non-
prescription drug, precursor chemical, or regulated
chemical meets the following criteria.
a. Any narcotic or other controlled substance, prescrip-
tion-only drug or device, nonprescription drug, pre-
cursor chemical, or regulated chemical that is
outdated, damaged, deteriorated, adulterated, mis-
branded, counterfeited, or contraband or suspected
of being adulterated, misbranded, counterfeited, or
contraband, or otherwise deemed unfit for human or
animal consumption shall be quarantined and physi-
cally separated from other narcotics or other con-
trolled substances, prescription-only drugs or
devices, nonprescription drugs, precursor chemicals,
or regulated chemicals until the narcotic or other
controlled substance, prescription-only drug or
device, nonprescription drug, precursor chemical, or
regulated chemical is destroyed or returned to the
manufacturer or wholesale distributor from which it
was acquired as authorized by the Board and the
FDA.
b. Any narcotic or other controlled substance, prescrip-
tion-only drug or device, nonprescription drug, pre-
cursor chemical, or regulated chemical whose
immediate or sealed outer or secondary containers or
product labeling are misbranded, counterfeited, or
contraband or suspected of being misbranded, coun-
terfeited, or contraband shall be quarantined and
physically separated from other narcotics or other
controlled substances, prescription-only drugs or
devices, nonprescription drugs, precursor chemicals,
or regulated chemicals until the narcotic or other
controlled substance, prescription-only drug or
device, nonprescription drug, precursor chemical, or
regulated chemical is destroyed or returned to the
manufacturer or wholesale distributor from which it
was acquired as authorized by the Board and the
FDA. When the immediate or sealed outer or sec-
ondary containers or product labeling are deter-
mined to be misbranded, counterfeited, or
contraband or suspected of being misbranded, coun-
terfeited, or contraband, the full-service drug whole-
sale permittee shall provide notice of the
misbranding, counterfeiting, or contrabanding or
suspected misbranding, counterfeiting, or contra-
banding within three business days of the determina-
tion to the Board, FDA, and manufacturer or
wholesale distributor from which the narcotic or
other controlled substance, prescription-only drug or
device, nonprescription drug, precursor chemical, or
regulated chemical was acquired.
c. Any narcotic or other controlled substance, prescrip-
tion-only drug or device, nonprescription drug, pre-
cursor chemical, or regulated chemical that has been
opened or used, but is not adulterated, misbranded,
counterfeited, or contraband or suspected of being
misbranded, counterfeited, or contraband shall be
identified as opened or used, or both, and quaran-
tined and physically separated from other narcotics
or other controlled substances, prescription-only
drugs or devices, nonprescription drugs, precursor
chemicals, or regulated chemicals until the narcotic
or other controlled substance, prescription-only drug
or device, nonprescription drug, precursor chemical,
or regulated chemical is destroyed or returned to the
manufacturer or wholesale distributor from which it
was acquired as authorized by the Board and the
FDA.
d. If the conditions under which a narcotic or other
controlled substance, prescription-only drug or
device, nonprescription drug, precursor chemical, or
regulated chemical has been returned cast doubt on
the safety, identity, strength, quality, or purity of the
narcotic or other controlled substance, prescription-
only drug or device, nonprescription drug, precursor
chemical, or regulated chemical, the narcotic or
other controlled substance, prescription-only drug or
device, nonprescription drug, precursor chemical, or
regulated chemical shall be quarantined and physi-
cally separated from other narcotics or other con-
trolled substances, prescription-only drugs or
devices, nonprescription drugs, precursor chemicals,
or regulated chemicals until the narcotic or other
controlled substance, prescription-only drug or
device, nonprescription drug, precursor chemical, or
regulated chemical is destroyed or returned to the
manufacturer or wholesale distributor from which it
was acquired as authorized by the Board and the
FDA, except as provided in subsection (I)(1)(d)(i).
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 43
i. If examination, testing, or other investigation
proves that the narcotic or other controlled sub-
stance, prescription-only drug or device, non-
prescription drug, precursor chemical, or
regulated chemical meets appropriate standards
of safety, identity, strength, quality, and purity,
it does not have to be destroyed or returned to
the manufacturer or wholesale distributor.
ii. In determining whether the conditions under
which a narcotic or other controlled substance,
prescription-only drug or device, nonprescrip-
tion drug, precursor chemical, or regulated
chemical has been returned cast doubt on the
safety, identity, strength, quality, or purity of
the narcotic or other controlled substance, pre-
scription-only drug or device, nonprescription
drug, precursor chemical, or regulated chemi-
cal, the full-service drug wholesale permittee
shall consider, among other things, the condi-
tions under which the narcotic or other con-
trolled substance, prescription-only drug or
device, nonprescription drug, precursor chemi-
cal, or regulated chemical has been held,
stored, or shipped before or during its return
and the condition of the narcotic or other con-
trolled substance, prescription-only drug or
device, nonprescription drug, precursor chemi-
cal, or regulated chemical and the condition of
its container, carton, or product labeling as a
result of storage or shipping.
e. For any narcotic or other controlled substance, pre-
scription-only drug or device, nonprescription drug,
precursor chemical, or regulated chemical identified
under subsections (I)(1)(a) or (b), the full-service
drug wholesale permittee shall ensure that the identi-
fied item or items and other evidence of criminal
activity, and accompanying documentation is
retained and not destroyed until its disposition is
authorized by the Board and the FDA.
2. A nonprescription drug wholesale permittee shall ensure
that the return of any nonprescription drug, precursor
chemical, or regulated chemical meets the following cri-
teria.
a. Any nonprescription drug, precursor chemical, or
regulated chemical that is outdated, damaged, deteri-
orated, adulterated, misbranded, counterfeited, or
contraband or suspected of being adulterated, mis-
branded, counterfeited, or contraband, or otherwise
deemed unfit for human or animal consumption
shall be quarantined and physically separated from
other nonprescription drugs, precursor chemicals, or
regulated chemicals until the nonprescription drug,
precursor chemical, or regulated chemical is
destroyed or returned to the manufacturer or whole-
sale distributor from which it was acquired as autho-
rized by the Board and the FDA.
b. Any nonprescription drug, precursor chemical, or
regulated chemical whose immediate or sealed outer
or secondary containers or product labeling are mis-
branded, counterfeited, or contraband or suspected
of being misbranded, counterfeited, or contraband
shall be quarantined and physically separated from
other nonprescription drugs, precursor chemicals, or
regulated chemicals until the nonprescription drug,
precursor chemical, or regulated chemical is
destroyed or returned to the manufacturer or whole-
sale distributor from which it was acquired as autho-
rized by the Board and the FDA. When the
immediate or sealed outer or secondary containers or
product labeling are determined to be misbranded,
counterfeited, or contraband or suspected of being
misbranded, counterfeited, or contraband, the non-
prescription drug wholesale permittee shall provide
notice of the misbranding, counterfeiting, or contra-
banding or suspected misbranding, counterfeiting, or
contrabanding within three business days of the
determination to the Board, FDA, and manufacturer
or wholesale distributor from which the nonprescrip-
tion drug, precursor chemical, or regulated chemical
was acquired.
c. Any nonprescription drug, precursor chemical, or
regulated chemical that has been opened or used, but
is not adulterated, misbranded, counterfeited, or
contraband or suspected of being misbranded, coun-
terfeited, or contraband, shall be identified as
opened or used, or both, and quarantined and physi-
cally separated from other nonprescription drugs,
precursor chemicals, or regulated chemicals until the
nonprescription drug, precursor chemical, or regu-
lated chemical is destroyed or returned to the manu-
facturer or wholesale distributor from which it was
acquired as authorized by the Board and the FDA.
d. If the conditions under which a nonprescription
drug, precursor chemical, or regulated chemical has
been returned cast doubt on the safety, identity,
strength, quality, or purity of the nonprescription
drug, precursor chemical, or regulated chemical, the
nonprescription drug, precursor chemical, or regu-
lated chemical shall be quarantined and physically
separated from other nonprescription drugs, precur-
sor chemicals, or regulated chemicals until the non-
prescription drug, precursor chemical, or regulated
chemical is destroyed or returned to the manufac-
turer or wholesale distributor from which it was
acquired as authorized by the Board and the FDA,
except as provided in subsection (I)(2)(d)(i).
i. If examination, testing, or other investigation
proves that the nonprescription drug, precursor
chemical, or regulated chemical meets appro-
priate standards of safety, identity, strength,
quality, and purity, the nonprescription drug,
precursor chemical, or regulated chemical does
not need to be destroyed or returned to the man-
ufacturer or wholesale distributor.
ii. In determining whether the conditions under
which a nonprescription drug, precursor chemi-
cal, or regulated chemical has been returned
cast doubt on the safety, identity, strength, qual-
ity, or purity of the nonprescription drug, pre-
cursor chemical, or regulated chemical, the
nonprescription drug wholesale permittee shall
consider, among other things, the conditions
under which the nonprescription drug, precur-
sor chemical, or regulated chemical has been
held, stored, or shipped before or during its
return and the condition of the nonprescription
drug, precursor chemical, or regulated chemical
and the condition of its container, carton, or
product labeling as a result of storage or ship-
ping.
e. For any nonprescription drug, precursor chemical, or
regulated chemical identified under subsections
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 44 Supp. 20-1 March 31, 2020
(I)(2)(a) or (b), the nonprescription drug wholesale
permittee shall ensure that the identified item or
items and other evidence of criminal activity, and
accompanying documentation is retained and not
destroyed until its disposition is authorized by the
Board and the FDA.
3. A full-service drug wholesale permittee and nonprescrip-
tion drug wholesale permittee shall comply with the
recordkeeping requirements of subsection (G) for all out-
dated, damaged, deteriorated, adulterated, misbranded,
counterfeited and contraband narcotics or other con-
trolled substances, prescription-only drugs or devices,
nonprescription drugs, precursor chemicals, or regulated
chemicals.
J. Facility. A full-service or nonprescription drug wholesale per-
mittee shall:
1. Ensure that the facility occupied by the full-service or
nonprescription drug wholesale permittee is of adequate
size and construction, well-lighted inside and outside,
adequately ventilated, and kept clean, uncluttered, and
sanitary;
2. Ensure that the permittee’s warehouse facility:
a. Is secure from unauthorized entry; and
b. Has an operational security system designed to pro-
vide protection against theft;
3. In a full-service drug wholesale facility, ensure that only
authorized personnel may enter areas where any narcotic
or other controlled substance, prescription-only drug or
device, nonprescription drug, precursor chemical, or reg-
ulated chemical is kept;
4. In a nonprescription drug wholesale facility, ensure that
only authorized personnel may enter areas where any
nonprescription drug, precursor chemical, or regulated
chemical is kept;
5. In a full-service drug wholesale facility, ensure that any
thermolabile narcotic or other controlled substance, pre-
scription-only drug or device, nonprescription drug, pre-
cursor chemical, or regulated chemical is stored in an
area where room temperature is maintained in compli-
ance with storage conditions prescribed on the product
label;
6. In a nonprescription drug wholesale facility, ensure that
any thermolabile nonprescription drug, precursor chemi-
cal, or regulated chemical is stored in an area where room
temperature is maintained in compliance with storage
conditions prescribed on the product label;
7. Make the facility available for inspection by a Board
compliance officer or other authorized officer of the law
as defined in A.R.S. § 32-1901(5) during regular business
hours;
8. In a full-service drug wholesale facility, provide a quar-
antine area for storage of any narcotic or other controlled
substance, prescription-only drug or device, nonprescrip-
tion drug, precursor chemical, or regulated chemical that
is outdated, damaged, deteriorated, adulterated, mis-
branded, counterfeited, or contraband or suspected of
being adulterated, misbranded, counterfeited, or contra-
band, otherwise deemed unfit for human or animal con-
sumption, or that is in an open container; and
9. In a nonprescription drug wholesale facility, provide a
quarantine area for storage of any nonprescription drug,
precursor chemical, or regulated chemical that is out-
dated, damaged, deteriorated, adulterated, misbranded,
counterfeited, or contraband or suspected of being adul-
terated, misbranded, counterfeited, or contraband, other-
wise deemed unfit for human or animal consumption, or
that is in an open container.
K. Quality controls.
1. A full-service drug wholesale permittee shall:
a. Ensure that any narcotic or other controlled sub-
stance, prescription-only drug or device, nonpre-
scription drug, precursor chemical, or regulated
chemical that meets the criteria specified in subsec-
tion (I)(1) is not sold, distributed, or delivered to any
person for human or animal consumption;
b. Ensure that a narcotic or other controlled substance,
prescription-only drug or device, nonprescription
drug, precursor chemical, or regulated chemical is
not manufactured, packaged, repackaged, labeled, or
relabeled by any of its employees;
c. Ensure that any narcotic or other controlled sub-
stance, prescription-only drug or device, nonpre-
scription drug, precursor chemical, or regulated
chemical stocked, sold, offered for sale, or delivered
is:
i. Kept clean,
ii. Protected from contamination and other deteri-
orating environmental factors, and
iii. Stored in a manner that complies with applica-
ble federal and state law and official compen-
dium storage requirements;
d. Maintain manual or automatic temperature and
humidity recording devices or logs to document con-
ditions in areas where any narcotic or other con-
trolled substance, prescription-only drug or device,
nonprescription drug, precursor chemical, or regu-
lated chemical is stored; and
e. Develop and implement a program to ensure that:
i. Any expiration-dated narcotic or other con-
trolled substance, prescription-only drug or
device, nonprescription drug, precursor chemi-
cal, or regulated chemical is reviewed regu-
larly;
ii. Any narcotic or other controlled substance, pre-
scription-only drug or device, nonprescription
drug, precursor chemical, or regulated chemical
that has less than 120 days remaining on the
expiration date, or is deteriorated, damaged, or
does not comply with federal law, is moved to a
quarantine area and not sold or distributed; and
iii. Any quarantined narcotic or other controlled
substance, prescription-only drug or device,
nonprescription drug, precursor chemical, or
regulated chemical is destroyed or returned to
the manufacturer or wholesale distributor from
which it was acquired.
2. A nonprescription drug wholesale permittee shall:
a. Ensure that any nonprescription drug, precursor
chemical, or regulated chemical that meets the crite-
ria specified in subsection (I)(2) is not sold, distrib-
uted, or delivered to any person for human or animal
consumption;
b. Ensure that a nonprescription drug, precursor chemi-
cal, or regulated chemical is not manufactured,
packaged, repackaged, labeled, or relabeled by any
of its employees;
c. Ensure that any nonprescription drug, precursor
chemical, or regulated chemical stocked, sold,
offered for sale, or delivered is:
i. Kept clean,
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 45
ii. Protected from contamination and other deteri-
orating environmental factors, and
iii. Stored in a manner that complies with applica-
ble federal and state law and official compen-
dium storage requirements;
d. Maintain manual or automatic temperature and
humidity recording devices or logs to document con-
ditions in areas where any nonprescription drug, pre-
cursor chemical, or regulated chemical is stored; and
e. Develop and implement a program to ensure that:
i. Any expiration-dated nonprescription drug,
precursor chemical, or regulated chemical is
reviewed regularly;
ii. Any nonprescription drug, precursor chemical,
or regulated chemical that has fewer than 120
days remaining on the expiration date, or is
deteriorated, damaged, or does not comply with
federal law, is moved to a quarantine area and
not sold or distributed; and
iii. Any quarantined nonprescription drug, precur-
sor chemical, or regulated chemical is
destroyed or returned to the manufacturer or
wholesale distributor from which it was
acquired.
L. Fingerprint clearance.
1. After receiving the state and federal criminal history
record of a designated representative, the Board shall
compare the record with the list of criminal offenses that
preclude a designated representative from receiving a fin-
gerprint clearance. If the designated representative’s
criminal history record does not contain any of the
offenses listed in subsection (L)(2), the Board shall issue
the designated representative a fingerprint clearance.
2. The Board shall not issue a fingerprint clearance to a des-
ignated representative who is awaiting trial for or who
has been convicted of committing or attempting or con-
spiring to commit one or more of the following offenses
in this state or the same or similar offenses in another
state or jurisdiction:
a. Unlawfully administering intoxicating liquors, con-
trolled substances, dangerous drugs, or prescription-
only drugs;
b. Sale of peyote;
c. Possession, use, or sale of marijuana, dangerous
drugs, prescription-only drugs, or controlled sub-
stances;
d. Manufacture or distribution of an imitation con-
trolled substance;
e. Manufacture or distribution of an imitation prescrip-
tion-only drug;
f. Possession or possession with intent to use an imita-
tion controlled substance;
g. Possession or possession with intent to use an imita-
tion prescription-only drug; or
h. A felony offense involving sale, distribution, or
transportation of, offer to sell, transport, or distrib-
ute, or conspiracy to sell, transport, or distribute
marijuana, dangerous drugs, prescription-only
drugs, or controlled substances.
3. If the Board determines, after conducting a state and fed-
eral criminal history record check, that it is not authorized
to issue a fingerprint clearance, the Board shall notify the
full-service drug wholesale applicant or permittee that
employs the designated representative that the Board is
not authorized to issue a fingerprint clearance. This
notice shall include the criminal history information on
which the denial was based. This criminal history infor-
mation is subject to dissemination restrictions under
A.R.S. § 41-1750 and federal law.
Historical Note
Former Rules 6.5110, 6.5120, 6.5130, 6.5140, 6.5210,
6.5220, 6.5230, 6.5240, 6.5310, 6.5320, 6.5410, and
6.5420. Amended effective August 10, 1978 (Supp. 78-
4). Amended effective April 20, 1982 (Supp. 82-2).
Amended subsection (A) effective August 12, 1988
(Supp. 88-3). Amended effective February 8, 1991 (Supp.
91-1). Amended effective August 24, 1992 (Supp. 92-3).
Amended by final rulemaking at 6 A.A.R. 4589, effective
November 14, 2000 (Supp. 00-4). Amended by final
rulemaking at 10 A.A.R. 232, effective March 6, 2004
(Supp. 04-1). Amended by final rulemaking at 11 A.A.R.
1105, effective April 30, 2005 (Supp. 05-1). Amended by
final rulemaking at 11 A.A.R. 4270, effective December
6, 2005 (Supp. 05-4). Amended by final rulemaking at 13
A.A.R. 3477, effective December 1, 2007 (Supp. 07-4).
Amended by final rulemaking at 19 A.A.R. 702, effective
June 1, 2013 (Supp. 13-2). Amended by final rulemaking
at 25 A.A.R. 1015, effective June 1, 2019 (Supp. 19-2).
R4-23-606. Resident-Pharmacy Permit: Community, Hospi-
tal, and Limited Service
A. Permit. A person shall not operate a pharmacy in Arizona
without a current Board-issued pharmacy permit.
B. Application.
1. To obtain a permit to operate a pharmacy in Arizona, a
person shall submit a completed application, on a form
available from the Board, and the fee specified in R4-23-
205.
2. Before issuing a pharmacy permit, the Board shall:
a. Receive and approve a completed permit applica-
tion; and
b. Receive a satisfactory compliance inspection report
on the facility from a Board compliance officer.
3. Before issuing a pharmacy permit, the Board may inter-
view the applicant and the pharmacist-in-charge, if differ-
ent from the applicant, at a Board meeting based on the
need for additional information.
C. Notification. A pharmacy permittee shall notify the Board
office within 10 days of changes involving the type of phar-
macy operated, telephone or fax number, e-mail or mailing
address, business name, or staff pharmacist. A pharmacy per-
mittee shall provide the Board office immediate notice of a
change of the pharmacist-in-charge.
D. If any nonprescription drugs are sold outside the pharmacy
area when the pharmacy area is closed, the pharmacy permit-
tee shall ensure that the business has a current, Board-issued
nonprescription drug permit as required in Section R4-23-603.
E. Change of ownership. A pharmacy permittee shall comply
with R4-23-601(F).
F. Relocation or remodel.
1. No fewer than 30 days before the relocation or remodel of
an existing pharmacy, the pharmacy permittee shall sub-
mit, electronically or manually, a completed application
for remodel or relocation using the form specified under
subsection (B). A fee is not required with an application
for remodel or relocation.
2. The new or remodeled facility shall pass a final inspec-
tion by a Board compliance officer before operations
begin.
G. Permit renewal. To renew a pharmacy permit, the permittee
shall comply with R4-23-602(D).
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 46 Supp. 20-1 March 31, 2020
Historical Note
Former Rules 6.6010, 6.6020, 6.6030, 6.6040, 6.6050,
6.6060, 6.6071, 6.6072, 6.6073, 6.6074, 6.6075, and
6.6076. Amended effective August 10, 1978 (Supp. 78-
4). Amended subsections (G) and (H) effective April 20,
1982 (Supp. 82-2). Amended subsection (L) effective
July 2, 1982 (Supp. 82-4). Amended subsections (G) and
(H) effective August 12, 1988 (Supp. 88-3). Amended
effective November 1, 1993 (Supp. 93-4). Section head-
ing amended effective April 5, 1996 (Supp. 96-2).
Amended by final rulemaking at 7 A.A.R. 3825, effective
August 9, 2001 (Supp. 01-3). Amended by final rulemak-
ing at 20 A.A.R. 1364, effective August 2, 2014 (Supp.
14-2). Amended by final rulemaking at 25 A.A.R. 1015,
effective June 1, 2019 (Supp. 19-2).
R4-23-607. Nonresident Permits
A. Permit. A person that is not a resident of Arizona shall not sell
or distribute any narcotic or other controlled substance, pre-
scription-only drug or device, nonprescription drug, precursor
chemical, or regulated chemical into Arizona without possess-
ing both:
1. A current Board-issued nonresident pharmacy permit,
nonresident manufacturer permit, nonresident full-service
or nonprescription drug wholesale permit, or nonresident
nonprescription drug permit; and
2. A current equivalent license or permit issued by the
licensing authority in the jurisdiction where the person
resides.
B. Application. To obtain a nonresident pharmacy, nonresident
manufacturer, nonresident full-service or nonprescription drug
wholesale, or nonprescription drug permit, a person shall sub-
mit a completed application, on a form furnished by the Board,
and the fee specified in R4-23-205.
C. Notification. A permittee shall submit notification of any
change required in this subsection using the permittee’s online
profile or as a written notice by mail, fax, or e-mail to the
Board office within 10 days of the change.
1. Nonresident pharmacy. A nonresident pharmacy permit-
tee shall notify the Board of changes involving the type of
pharmacy operated, address, telephone number, business
name, or pharmacist-in-charge.
2. Nonresident manufacturer. A nonresident manufacturer
permittee shall notify the Board of changes involving
listed drugs, address, telephone number, business name,
or manager, including manager’s telephone number.
3. Nonresident drug wholesaler. A nonresident full-service
or nonprescription drug wholesale permittee shall notify
the Board of changes involving the types of drugs sold or
distributed, address, telephone number, business name, or
manager or designated representative, including the man-
ager’s or designated representative’s telephone number.
For a change of designated representative, a nonresident
full-service drug wholesale permittee shall submit the
documentation, fingerprints, and fee required with the
application under subsection (B).
4. Nonresident nonprescription drug retailer. A nonresident
nonprescription drug permittee shall notify the Board of
changes involving permit category, address, telephone
number, business name, or manager, including manager’s
telephone number.
D. Change of ownership. A nonresident permittee shall comply
with R4-23-601(F).
E. Drug sales.
1. Nonresident pharmacy. A nonresident pharmacy permit-
tee shall:
a. Not sell, distribute, give away, or dispose of any nar-
cotic or other controlled substance or prescription-
only drug or device to anyone in Arizona except:
i. A pharmacy, drug manufacturer, or full-service
drug wholesaler currently permitted by the
Board;
ii. A medical practitioner currently licensed under
A.R.S. Title 32; or
iii. An Arizona resident upon receipt of a valid pre-
scription order for the resident;
b. Not sell, distribute, give away, or dispose of any
nonprescription drug, precursor chemical, or regu-
lated chemical to anyone in Arizona except:
i. A pharmacy, drug manufacturer, full-service or
nonprescription drug wholesaler, or nonpre-
scription drug retailer currently permitted by
the Board;
ii. A medical practitioner currently licensed under
A.R.S. Title 32; or
iii. An Arizona resident either upon receipt of a
valid prescription order for the resident or in
the original container packaged and labeled by
the manufacturer;
c. Except for a drug sale that results from the receipt
and dispensing of a valid prescription order for an
Arizona resident, maintain a copy of the current per-
mit or license of each person in Arizona that buys,
receives, or disposes of any narcotic or other con-
trolled substance, prescription-only drug or device,
nonprescription drug, precursor chemical, or regu-
lated chemical; and
d. Provide permit and license records upon request, if
immediately available, or in no fewer than two busi-
ness days from the date of the request of a Board
compliance officer or other authorized officer of the
law as defined in A.R.S. § 32-1901.
2. Nonresident manufacturer. A nonresident manufacturer
permittee shall:
a. Not sell, distribute, give away, or dispose of any nar-
cotic or other controlled substance or prescription-
only drug or device to anyone in Arizona except a
pharmacy, drug manufacturer, or full-service drug
wholesaler currently permitted by the Board or a
medical practitioner currently licensed under A.R.S.
Title 32;
b. Not sell, distribute, give away, or dispose of any
nonprescription drug, precursor chemical, or regu-
lated chemical to anyone in Arizona except a phar-
macy, drug manufacturer, full-service or
nonprescription drug wholesaler, or nonprescription
drug retailer currently permitted by the Board or a
medical practitioner currently licensed under A.R.S.
Title 32;
c. Maintain a copy of the current permit or license of
each person in Arizona that buys, receives, or dis-
poses of any narcotic or other controlled substance,
prescription-only drug or device, nonprescription
drug, precursor chemical, or regulated chemical; and
d. Provide permit and license records upon request, if
immediately available, or in no more than two busi-
ness days from the date of the request of a Board
compliance officer or other authorized officer of the
law as defined in A.R.S. § 32-1901.
3. Nonresident full-service drug wholesaler. In addition to
complying with the distributions restrictions specified in
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 47
A.R.S. § 32-1983, a nonresident full-service drug whole-
sale permittee shall:
a. Not sell, distribute, give away, or dispose of, any
narcotic or other controlled substance, prescription-
only drug or device, nonprescription drug, precursor
chemical, or regulated chemical to anyone in Ari-
zona, except in the original container, packaged and
labeled by the manufacturer or repackager;
b. Not package, repackage, label, or relabel any nar-
cotic or other controlled substance, prescription-
only drug or device, nonprescription drug, precursor
chemical, or regulated chemical for shipment or
delivery to anyone in Arizona;
c. Provide track and trace documents required under
the Drug Supply Chain and Security Act upon
request, if immediately available, or in no more than
two business days from the date of the request of a
Board compliance officer or other authorized officer
of the law as defined in A.R.S. § 32-1901;
d. Not sell, distribute, give away, or dispose of any nar-
cotic or other controlled substance, prescription only
drug or device, nonprescription drug, precursor
chemical, or regulated chemical to anyone in Ari-
zona except a pharmacy, drug manufacturer, or full
service drug wholesaler currently permitted by the
Board or a medical practitioner currently licensed
under A.R.S. Title 32;
e. Not sell, distribute, give away, or dispose of any
nonprescription drug, precursor chemical, or regu-
lated chemical to anyone in Arizona except a phar-
macy, drug manufacturer, full-service or
nonprescription drug wholesaler, or nonprescription
drug retailer currently permitted by the Board or a
medical practitioner currently licensed under A.R.S.
Title 32;
f. Maintain a copy of the current permit or license of
each person in Arizona that buys, receives, or dis-
poses of any narcotic or other controlled substance,
prescription-only drug or device, nonprescription
drug, precursor chemical, or regulated chemical; and
g. Provide permit and license records upon request, if
immediately available, or in no more than two busi-
ness days from the date of the request of a Board
compliance officer or other authorized officer of the
law as defined in A.R.S. § 32-1901.
4. Nonresident nonprescription drug wholesaler. A nonresi-
dent nonprescription drug wholesale permittee shall:
a. Not sell, distribute, give away, or dispose of any
nonprescription drug, precursor chemical, or regu-
lated chemical to anyone in Arizona, except in the
original container, packaged and labeled by the man-
ufacturer or repackager;
b. Not package, repackage, label, or relabel any non-
prescription drug, precursor chemical, or regulated
chemical for shipment or delivery to anyone in Ari-
zona;
c. Not sell, distribute, give away, or dispose of any
nonprescription drug, precursor chemical, or regu-
lated chemical to anyone in Arizona except a phar-
macy, drug manufacturer, full-service or
nonprescription drug wholesaler, or nonprescription
drug retailer currently permitted by the Board or a
medical practitioner currently licensed under A.R.S.
Title 32;
d. Maintain a copy of the current permit or license of
each person in Arizona that buys, receives, or dis-
poses of any nonprescription drug, precursor chemi-
cal, or regulated chemical; and
e. Provide permit and license records upon request, if
immediately available, or in no more than two busi-
ness days from the date of the request of a Board
compliance officer or other authorized officer of the
law as defined in A.R.S. § 32-1901.
5. Nonresident nonprescription drug retailer. A nonresident
nonprescription drug permittee shall not:
a. Sell, distribute, give away, or dispose of a nonpre-
scription drug, precursor chemical, or regulated
chemical to anyone in Arizona except in the original
container packaged and labeled by the manufacturer;
b. Package, repackage, label, or relabel any drug, pre-
cursor chemical, or regulated chemical for shipment
or delivery to anyone in Arizona; or
c. Sell, distribute, give away, or dispose of any drug,
precursor chemical, or regulated chemical to anyone
in Arizona that exceeds its expiration date, is con-
taminated or deteriorated from excessive heat, cold,
sunlight, moisture, or other factors, or does not com-
ply with federal law.
F. When selling or distributing any narcotic or other controlled
substance, prescription-only drug or device, nonprescription
drug, precursor chemical, or regulated chemical into Arizona,
a nonresident pharmacy, nonresident manufacturer, nonresi-
dent full-service or nonprescription drug wholesale, or nonpre-
scription drug permittee shall comply with federal law, the
permittee’s resident state drug law, and this Section.
Historical Note
Former Rules 6.6110, 6.6120, and 6.6130; Amended
effective August 10, 1978 (Supp. 78-4). Repealed effec-
tive July 24, 1985 (Supp. 85-4). New Section adopted by
final rulemaking at 6 A.A.R. 4589, effective November
14, 2000 (Supp. 00-4). Amended by final rulemaking at 7
A.A.R. 3825, effective August 9, 2001 (Supp. 01-3).
Amended by final rulemaking at 10 A.A.R. 232, effective
March 6, 2004 (Supp. 04-1). Amended by final rulemak-
ing at 13 A.A.R. 520, effective April 7, 2007 (Supp. 07-
1). Amended by final rulemaking at 13 A.A.R. 3477,
effective December 1, 2007 (Supp. 07-4). Amended by
final rulemaking at 25 A.A.R. 1015, effective June 1,
2019 (Supp. 19-2). Amended by final rulemaking at 26
A.A.R. 223, effective March 14, 2020 (Supp. 20-1).
R4-23-608. Change of Personnel and Responsibility
A. A community, hospital, or limited-service pharmacy permittee
shall give the Board:
1. Notice by mail, facsimile, or electronic mail within ten
days of employing or terminating a pharmacist; and
2. Immediate notice of designating or terminating a pharma-
cist-in-charge.
B. Responsibility of ownership and management. The owner and
management of a pharmacy shall:
1. Ensure that pharmacists, interns, and other pharmacy
employees comply with state and federal laws and admin-
istrative rules; and
2. Not overrule a pharmacist in matters of pharmacy ethics
and interpreting laws pertaining to the practice of phar-
macy or the distribution of drugs and devices.
C. The Board may suspend or revoke a pharmacy permit if the
owner or management of a pharmacy violates subsection (B).
Historical Note
Former Rules 6.6140 and 6.6150; Amended subsection
(A) effective August 9, 1983 (Supp. 83-4). Amended
effective November 1, 1993 (Supp. 93-4). Amended by
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 48 Supp. 20-1 March 31, 2020
final rulemaking at 7 A.A.R. 4253, effective September
11, 2001 (Supp. 01-3).
R4-23-609. Pharmacy Area of Community Pharmacy
A. Minimum area of community pharmacy. The minimum area of
a community pharmacy, the actual area primarily devoted to
stocking drugs restricted to pharmacists, and to the compound-
ing and dispensing of prescription medication, exclusive of
office area or other support function area, shall not be less than
300 square feet. A maximum of three pharmacy personnel
may practice or work simultaneously in the minimum area.
The pharmacy permittee shall provide an additional 60 square
feet of floor area for each additional pharmacist, graduate
intern, pharmacy intern, pharmacy technician, pharmacy tech-
nician trainee, or support personnel who may practice or work
simultaneously. All of the allotted square footage area, includ-
ing adequate shelving, shall lend itself to efficient pharmaceu-
tical practice and permit free movement and visual
surveillance of personnel by the pharmacist.
B. Compounding and dispensing counter. On or after January 6,
2004, a pharmacy permit applicant or remodel or relocation
applicant shall provide a compounding and dispensing counter
that provides a minimum of three square feet of pharmacy
counter working area of not less than 16 inches in depth and 24
inches in length for the practice of one pharmacist, graduate
intern, pharmacy intern, pharmacy technician, or pharmacy
technician trainee. For each additional pharmacist, graduate
intern, pharmacy intern, pharmacy technician, or pharmacy
technician trainee practicing simultaneously, there shall be an
additional three square feet of pharmacy counter working area
of not less than 16 inches in depth and 24 inches in length. The
Board shall determine a pharmacy’s total required compound-
ing and dispensing counter area by multiplying the maximum
number of personnel allowed in the pharmacy area using the
requirements specified in subsection (A) by three square feet
per person. A pharmacy permittee or pharmacist-in-charge
may operate the pharmacy with a total pharmacy counter
working area specified in subsection (A) that is equal to the
actual maximum number of pharmacists, graduate interns,
pharmacy interns, pharmacy technicians, and pharmacy tech-
nician trainees, working simultaneously in the pharmacy area
times three square feet per person.
C. Working area for compounding and dispensing counter. The
aisle floor area used by the pharmacist, graduate intern, phar-
macy intern, pharmacy technician, or pharmacy technician
trainee at the compounding and dispensing counter shall
extend the full length of the counter and be clear and continu-
ous for a minimum of 36 inches from any counter, fixture, or
structure.
D. Area for patient counseling. On or after April 1, 1995, a phar-
macy permit applicant or remodel or relocation applicant shall
provide a separate and distinct patient counseling area that
provides patient privacy. This subsection does not apply to a
pharmacy exempt from the requirements of R4-23-402(B).
E. Narcotic cabinet or safe. To prevent diversion, narcotics and
other controlled substances may be:
1. Kept in a separate locked cabinet or safe, or
2. Dispersed throughout the pharmacy’s prescription-only
drug stock.
F. Building security standard of community pharmacy area. The
pharmacy area shall be enclosed by a permanent barrier or par-
tition from floor or counter to structural ceiling or roof, with
entry doors that can be securely locked. The barrier shall be
designed so that only a pharmacist can access the area where
prescription-only drugs, narcotics, and other controlled sub-
stances are stored, compounded and dispensed. The permanent
barrier may be constructed of other than a solid material. If
constructed of a material other than a solid, the openings or
interstices of the material shall not be large enough to permit
removal of items in the pharmacy area through the barrier.
Any material used in the construction of the permanent barrier
must be of sufficient strength and thickness that it cannot be
readily or easily removed, penetrated, or bent. The pharmacy
permittee shall submit plans and specifications of the perma-
nent barrier to the Board for approval.
G. Drug storage and security.
1. The pharmacy permittee shall ensure that drugs and
devices are stored in a dry, well-lit, ventilated, and clean
and orderly area. The pharmacy permittee shall maintain
the drug storage area at temperatures that ensure the
integrity of the drugs before dispensing as stated in the
official compendium defined in A.R.S. § 32-1901(55) or
the manufacturer’s or distributor’s labeling.
2. If the pharmacy permittee needs additional storage area
for drugs that are restricted to sale by a pharmacist, the
pharmacy permittee shall ensure that the area is contained
by a permanent barrier from floor or counter to structural
ceiling or roof. The pharmacy permittee shall lock all
doors and gates to the drug storage area. Only a pharma-
cist with a key is permitted to enter the storage area,
except in an extreme emergency.
H. A pharmacy permittee or pharmacist-in-charge shall ensure
that the pharmacy working counter area is protected from
unauthorized access while the pharmacy is open for business
by a barrier not less than 66 inches in height or another method
approved by the Board or its designee.
Historical Note
Former Rules 6.6210, 6.6220, 6.6230, 6.6240, 6.6250,
6.6310, 6.6320, and 6.6330; Amended effective August
10, 1978 (Supp. 78-4). Amended effective August 9,
1983 (Supp. 83-4). Amended effective November 1, 1993
(Supp. 93-4). Amended effective April 1, 1995; filed with
the Secretary of State January 31, 1995 (Supp. 95-1).
Amended by final rulemaking at 9 A.A.R. 5030, effective
January 3, 2004 (Supp. 03-4). Amended by final
rulemaking at 19 A.A.R. 97, effective March 10, 2013
(Supp. 13-1).
R4-23-610. Community Pharmacy Personnel and Security
Procedures
A. Every pharmacy shall have a pharmacist designated as the
“pharmacist-in-charge.”
1. The pharmacist-in-charge shall ensure the communica-
tion and compliance of Board directives to the manage-
ment, other pharmacists, interns, and technicians of the
pharmacy.
2. The pharmacist-in-charge shall:
a. Ensure that all pharmacy policies and procedures
required under 4 A.A.C. 23 are prepared, imple-
mented, and complied with;
b. Review biennially and, if necessary, revise all phar-
macy policies and procedures required under 4
A.A.C. 23;
c. Document the review required under subsection
(A)(2)(b);
d. Ensure that all pharmacy policies and procedures
required under 4 A.A.C. 23 are assembled as a writ-
ten or electronic manual; and
e. Make all pharmacy policies and procedures required
under 4 A.A.C. 23 available in the pharmacy for
employee reference and inspection by the Board or
its staff.
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 49
B. Personnel permitted in the pharmacy area of a community
pharmacy include pharmacists, graduate interns, pharmacy
interns, compliance officers, drug inspectors, peace officers
acting in their official capacity, other persons authorized by
law, pharmacy technicians, pharmacy technician trainees, sup-
port personnel, and other designated personnel. Pharmacy
interns, graduate interns, pharmacy technicians, pharmacy
technician trainees, support personnel, and other designated
personnel shall be permitted in the pharmacy area only when a
pharmacist is on duty, except in an extreme emergency as
defined in R4-23-110.
1. The pharmacist-in-charge shall comply with the mini-
mum area requirements as described in R4-23-609 for a
community pharmacy and for compounding and dispens-
ing counter area.
2. A pharmacist employed by a pharmacy shall ensure that
the pharmacy is physically secure while the pharmacist is
on duty.
C. In a community pharmacy, a pharmacist shall ensure that the
pharmacy area, and any additional storage area for drugs that
is restricted to access only by a pharmacist is locked when a
pharmacist is not present, except in an extreme emergency.
D. A pharmacist is the only person permitted by the Board to
unlock the pharmacy area or any additional storage area for
drugs restricted to access only by a pharmacist, except in an
extreme emergency.
E. A pharmacy permittee or pharmacist-in-charge shall ensure
that any prescription-only drugs and controlled substances
received in an area outside the pharmacy area are immediately
transferred unopened to the pharmacy area. The pharmacist-
in-charge shall ensure that any prescription-only drug and con-
trolled substance shipments are opened and marked by phar-
macy personnel in the pharmacy area under the supervision of
a pharmacist, graduate intern, or pharmacy intern.
F. A pharmacy permittee or pharmacist-in-charge may provide a
small opening or slot through which a written prescription
order or prescription medication container to be refilled may
be left in the prescription area when the pharmacist is not pres-
ent.
G. A pharmacist shall ensure that prescription medication is not
left outside the prescription area or picked up by the patient
when the pharmacist is not present by either:
1. Delivering the prescription medication to the patient, or
2. Securing the prescription medication inside the locked
pharmacy, except when using an automated storage and
distribution system that complies with the requirements
of R4-23-614.
Historical Note
Former Rules 6.6410, 6.6420, 6.6430, 6.6440, 6.6450,
6.6460, 6.6470, 6.6480, and 6.6490; Amended subsection
(F), deleted subsection (I) effective August 9, 1983
(Supp. 83-4). Amended effective May 16, 1990 (Supp.
90-2). Amended effective November 1, 1993 (Supp. 93-
4). Amended effective April 1, 1995; filed with the Secre-
tary of State January 31, 1995 (Supp. 95-1). Amended by
final rulemaking at 5 A.A.R. 4441, effective November 2,
1999 (Supp. 99-4). Amended by final rulemaking at 10
A.A.R. 4453, effective December 4, 2004 (Supp. 04-4).
Amended by final rulemaking at 12 A.A.R. 3032, effec-
tive October 1, 2006 (Supp. 06-3). Amended by final
rulemaking at 13 A.A.R. 2631, effective September 8,
2007 (Supp. 07-3).
R4-23-611. Pharmacy Facilities
A. Facilities. A pharmacy permittee or pharmacist-in-charge shall
ensure that:
1. A pharmacy’s facilities are constructed according to state
and local laws and ordinances;
2. A pharmacy facility’s:
a. Walls, ceilings, windows, floors, shelves, and equip-
ment are clean and in good repair and order; and
b. Counters, shelves, aisles, and open spaces are not
cluttered;
3. Adequate trash receptacles are provided and emptied
periodically during the day;
4. A pharmacy facility of any pharmacy permit issued or
pharmacy remodeled after February 1, 2014 provides
access to toilet facilities either:
a. Within the pharmacy area, or
b. No further than a walking distance of 100 feet from
the pharmacy area or an alternative distance
approved by the Board or its designee;
5. The toilet facilities are maintained in a sanitary condition
and in good repair;
6. All professional personnel and staff of the pharmacy keep
themselves and their apparel clean while in the pharmacy
area;
7. No animals, except licensed assistant animals and guard
animals, are allowed in the pharmacy;
8. The pharmacy facility is kept free of insects and rodents;
and
9. There is a sink with hot and cold running water, other
than a sink in a toilet facility, within the pharmacy area
for use in preparing drug products.
B. Supply of drugs and chemicals. A pharmacy permittee or phar-
macist-in-charge shall ensure that:
1. A pharmacy maintains a stock of drugs and chemicals
that:
a. Are sufficient to meet the normal demands of the
trading area or patient base the pharmacy serves; and
b. Meet all standards of strength and purity as estab-
lished by the official compendiums;
2. All stock, materials, drugs, and chemicals held for ulti-
mate sale or supply to the consumer are not contami-
nated;
3. Policies and procedures are developed, implemented, and
complied with to prevent the sale or use of a drug or
chemical:
a. That exceeds its expiration date;
b. That is deteriorated or damaged by reason of age,
heat, light, cold, moisture, crystallization, chemical
reaction, rupture of coating, disintegration, solidifi-
cation, separation, discoloration, change of odor,
precipitation, or other change as determined by
organoleptic examination or by other means;
c. That is improperly labeled;
d. Whose container is defective; or
e. That does not comply with federal law; and
4. The policies and procedures described in subsection
(B)(3):
a. Are made available in the pharmacy for employee
reference and inspection by the Board or its desig-
nee; and
b. Provide the following:
i. Any expiration-dated drug or chemical is
reviewed regularly;
ii. Any drug or chemical that exceeds its expira-
tion date, is deteriorated or damaged, improp-
erly labeled, has a defective container, or does
not comply with federal law, is moved to a
quarantine area and not sold or distributed; and
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 50 Supp. 20-1 March 31, 2020
iii. Any quarantined drug or chemical is properly
destroyed or returned to its source of supply.
Historical Note
Former Rules 6.6510, 6.6520, 6.6530, 6.6540, 6.6550,
6.6560, 6.6570, 6.6580, 6.6600, 6.6610, 6.6620, 6.6630,
6.6640, 6.6650, and 6.6660; Amended subsection (B)
effective August 9, 1983 (Supp. 83-4). Amended effec-
tive April 1, 1995; filed with the Secretary of State Janu-
ary 31, 1995 (Supp. 95-1). Amended by final rulemaking
at 7 A.A.R. 4253, effective September 11, 2001 (Supp.
01-3). Amended by final rulemaking at 12 A.A.R. 3032,
effective October 1, 2006 (Supp. 06-3). Amended by final
rulemaking at 19 A.A.R. 4165, effective February 1, 2014
(Supp. 13-4).
R4-23-612. Equipment
A pharmacy permittee or pharmacist-in-charge shall ensure that a
pharmacy has the necessary equipment to allow a pharmacist to
practice the profession of pharmacy, including the following:
1. Adequate refrigeration equipment dedicated to the stor-
age of drugs and biologicals;
2. A C-V controlled substance register, if C-V controlled
substances are sold without an order of a medical practi-
tioner;
3. Graduates in assorted sizes;
4. One mortar and pestle, not required if the pharmacy per-
mittee states in the application that compounding will not
be performed in the pharmacy;
5. Spatulas of assorted sizes including one nonmetallic;
6. Prescription balance, Class A with weights or an elec-
tronic balance of equal or greater accuracy, not required if
the pharmacy permittee states in the application that com-
pounding will not be performed in the pharmacy;
7. One ointment tile or equivalent, not required if the phar-
macy permittee states in the application that compound-
ing will not be performed in the pharmacy
8. A current hard-copy or access to a current electronic-
copy of the Arizona Pharmacy Act and administrative
rules and Arizona Controlled Substance Act;
9. A professional reference library consisting of a minimum
of one current reference or text, in hard-copy or elec-
tronic media, addressing the following subject areas:
a. Pharmacology or toxicology,
b. Therapeutics,
c. Drug compatibility, and
d. Drug product equivalency;
10. An assortment of labels, including prescription labels,
transfer labels for controlled substances, and cautionary
and warning labels;
11. A red C stamp as defined in R4-23-110, if C-III, C-IV,
and C-V controlled substance invoices are not filed sepa-
rately from other invoices;
12. Current antidote and drug interaction information; and
13. Regional poison control phone number prominently dis-
played in the pharmacy area.
Historical Note
Former Rule 6.6670; Former Section R4-23-612 repealed,
new Section R4-23-612 adopted effective August 10, 1978
(Supp. 78-4). Amended effective August 9, 1983 (Supp. 83-
4). Amended effective April 5, 1996 (Supp. 96-2).
Amended by final rulemaking at 7 A.A.R. 4253, effective
September 11, 2001 (Supp. 01-3). Amended by final
rulemaking at 19 A.A.R. 4165, effective February 1, 2014
(Supp. 13-4).
R4-23-613. Procedure for Discontinuing a Pharmacy
A. A pharmacy permittee or pharmacist-in-charge shall provide
written notice to the Board and the Drug Enforcement Admin-
istration (D.E.A.) at least 14 days before discontinuing opera-
tion of the pharmacy. The notice shall contain the following
information:
1. Name, address, pharmacy permit number, and D.E.A.
registration number of the pharmacy discontinuing busi-
ness;
2. Name, address, pharmacy permit number (if applicable),
and D.E.A. registration number (if applicable) of the
licensee, permittee, or registrant to whom any narcotic or
other controlled substance, prescription-only drug or
device, nonprescription drug, precursor chemical, or reg-
ulated chemical will be sold or transferred;
3. Name and address of the location where the discontinuing
pharmacy’s records of purchase and disbursement of any
narcotic or other controlled substance, prescription-only
drug or device, nonprescription drug, precursor chemical,
or regulated chemical will be kept and the person respon-
sible for the records. These records shall be kept for a
minimum of three years from the date the pharmacy is
discontinued;
4. Name and address of the location where the discontinuing
pharmacy’s prescription files and patient profiles will be
kept and the person responsible for the files and profiles.
These records shall be kept for a minimum of seven years
from the date the last original or refill prescription was
dispensed; and
5. The proposed date of discontinuing business operations.
B. The pharmacy permittee shall ensure that all pharmacy signs
and symbols are removed from both the inside and outside of
the premises.
C. The pharmacy permittee or pharmacist-in-charge shall ensure
that all state permits and certificates of registration are
returned to the Board office and that D.E.A. registration certif-
icates and unused D.E.A. Schedule II order forms are returned
to the D.E.A. Regional Office in Phoenix.
D. The pharmacist-in-charge of the pharmacy discontinuing busi-
ness shall ensure that:
1. Only a pharmacist has access to the prescription-only
drugs and controlled substances until they are transferred
to the licensee, permittee, or registrant listed in subsec-
tion (A)(2);
2. All narcotics or other controlled substances, prescription-
only drugs or devices, nonprescription drugs, precursor
chemicals, or regulated chemicals are removed from the
premises on or before the date the pharmacy is discontin-
ued; and
3. All controlled substances are transferred as follows:
a. Take an inventory of all controlled substances that
are transferred using the procedures in R4-23-1003;
b. Include a copy of the inventory with the controlled
substances that are transferred;
c. Keep the original of the inventory with the discon-
tinued pharmacy’s records of narcotic or other con-
trolled substance, prescription-only drug or device,
nonprescription drug, precursor chemical, or regu-
lated chemical purchase and disbursement for a min-
imum of three years from the date the pharmacy is
discontinued;
d. Use a D.E.A. form 222 to transfer any Schedule II
controlled substances; and
e. Transfer controlled substances that need destruction
in the same manner as all other controlled sub-
stances.
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 51
E. Upon receipt of outdated or damaged controlled substances
from a discontinued pharmacy, the licensee, permittee, or reg-
istrant described in subsection (A)(2) shall contact a D.E.A.
registered reverse distributor for proper destruction of out-
dated or damaged controlled substances. If there are controlled
substances a reverse distributor will not accept, the licensee,
permittee, or registrant shall then contact the Board office and
request an inspection for the purpose of drug destruction.
F. During the three-year record retention period specified in sub-
section (A)(3), the person described in subsection (A)(3) shall
provide to the Board upon its request a discontinued phar-
macy’s records of the purchase and disbursement of narcotics
or other controlled substances, prescription-only drugs or
devices, nonprescription drugs, precursor chemicals, or regu-
lated chemicals.
G. During the seven-year record retention period specified in sub-
section (A)(4), the person described in subsection (A)(4) shall
provide to the Board upon its request a discontinued phar-
macy’s records of prescription files and patient profiles.
Historical Note
New Section made by final rulemaking at 7 A.A.R. 3825,
effective August 9, 2001 (Supp. 01-3). Amended by final
rulemaking at 11 A.A.R. 1105, effective April 30, 2005
(Supp. 05-1). Amended by final rulemaking at 12 A.A.R.
1912, effective July 1, 2006 (Supp. 06-2). Amended by
final rulemaking at 14 A.A.R. 3670, effective November
8, 2008 (Supp. 08-3).
R4-23-614. Automated Storage and Distribution System
A. Before using an automated storage and distribution system, a
pharmacy permittee or pharmacist-in-charge shall:
1. Ensure that the automated storage and distribution system
and the policies and procedures comply with subsection
(B); and
2. Notify the Board in writing of the intent to use an auto-
mated storage and distribution system, including the type
or name of the system.
B. A pharmacy permittee or pharmacist-in-charge shall establish
policies and procedures for appropriate performance and use
of the automated storage and distribution system that:
1. Ensure that the automated storage and distribution system
is in good working order while maintaining appropriate
recordkeeping and security safeguards;
2. Ensure that an automated storage and distribution system
used by the pharmacy that allows access to drugs or
devices by a patient:
a. Only contains prescriptions that:
i. Do not require oral consultation as specified in
R4-23-402(B); and
ii. Are properly labeled and verified by a pharma-
cist before placement into the automated stor-
age and distribution system and subsequent
release to patients;
b. Allows a patient to choose whether or not to use the
system;
c. Is located either in a wall of a properly permitted
pharmacy or within 20 feet of a properly permitted
pharmacy if the automated storage and distribution
system is secured against the wall or floor in such a
manner that prevents the automated storage and dis-
tribution system’s unauthorized removal;
d. Provides a method to identify the patient and only
release that patient’s prescriptions;
e. Is secure from access and removal of drugs or
devices by unauthorized individuals;
f. Provides a method for a patient to obtain a consulta-
tion with a pharmacist if requested by the patient;
and
g. Does not allow the system to dispense refilled pre-
scriptions if a pharmacist determines that the patient
requires oral counseling as specified in R4-23-
402(B);
3. Ensure that an automated storage and distribution system
used by the pharmacy that allows access to drugs or
devices only by authorized licensed personnel for the pur-
poses of administration based on a valid prescription
order or medication order:
a. Provides for adequate security to prevent unautho-
rized individuals from accessing or obtaining drugs
or devices; and
b. Provides for the filling, stocking, or restocking of all
drugs or devices in the system only by a Board
licensee or other authorized licensed personnel; and
4. Implement an ongoing quality assurance program that
monitors compliance with the established policies and
procedures of the automated storage and distribution sys-
tem and federal and state law.
C. A pharmacy permittee or pharmacist-in-charge shall:
1. Ensure that the policies and procedures required under
subsection (B) are prepared, implemented, and complied
with;
2. Review biennially and, if necessary, revise the policies
and procedures required under subsection (B);
3. Document the review required under subsection (C)(2);
4. Assemble the policies and procedures as a written or elec-
tronic manual; and
5. Make the policies and procedures available for employee
reference and inspection by the Board or its staff within
the pharmacy and at any location outside the pharmacy
where the automated storage and distribution system is
used.
D. The Board may prohibit a pharmacy permittee or pharmacist-
in-charge from using an automated storage and distribution
system if the pharmacy permittee or the pharmacy permittee’s
employees do not comply with the requirements of subsections
(A), (B), or (C).
Historical Note
New Section made by final rulemaking at 13 A.A.R. 616,
effective April 7, 2007 (Supp. 07-1).
R4-23-615. Mechanical Storage and Counting Device for a
Drug in Solid, Oral Dosage Form
A. A pharmacy permittee or pharmacist-in-charge shall ensure
that a mechanical storage and counting device for a drug in a
solid, oral dosage form that is used by a pharmacist or a phar-
macy intern, graduate intern, pharmacy technician, or phar-
macy technician trainee under the supervision of a pharmacist
complies with the following method to identify the contents of
the device:
1. The drug name and strength are affixed to the front of
each cell or cassette of the device;
2. A paper or electronic log is kept for each cell or cassette
that contains:
a. An identification of the cell or cassette by the drug
name and strength or the number of the cell or cas-
sette;
b. The drug’s manufacturer or National Drug Code
(NDC) number;
c. The expiration date and lot number from the manu-
facturer’s stock bottle that is used to fill the cell or
cassette. If multiple lot numbers of the same drug
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 52 Supp. 20-1 March 31, 2020
are added to a cell or cassette, each lot number and
expiration date shall be documented, and the earliest
expiration date shall become the expiration date of
the mixed lot of drug in the cell or cassette;
d. The date the cell or cassette is filled;
e. Documentation of the identity of the licensee who
placed the drug into the cell or cassette; and
f. If the licensee who filled the cell or cassette is not a
pharmacist, documentation of the identity of the
pharmacist who supervised the non-pharmacist
licensee who filled the cell or cassette; and
3. The paper or electronic log is available in the pharmacy
for inspection by the Board or its designee for not less
than two years.
B. A pharmacy permittee or pharmacist-in-charge shall ensure
that any drug previously counted by a mechanical storage and
counting device for a drug in a solid, oral dosage form that has
not left the pharmacy is not returned to the drug’s cell, cas-
sette, or stock bottle, unless the drug return method is
approved by the Board or its designee as specified in subsec-
tion (G). This subsection does not prevent a pharmacy permit-
tee or pharmacist-in-charge from using a manual or
mechanical counting device to count and dispense a previously
counted drug that has not left the pharmacy if the previously
counted drug is dispensed before its beyond-use-date.
C. A pharmacy permittee or pharmacist-in-charge shall ensure
the accuracy of any mechanical storage and counting device
for a drug in a solid, oral dosage form that is used by a phar-
macist or a pharmacy intern, graduate intern, pharmacy techni-
cian, or pharmacy technician trainee under the supervision of a
pharmacist by documenting completion of the following:
1. Training in the maintenance, calibration, and use of the
mechanical storage and counting device for each
employee who uses the mechanical storage and counting
device;
2. Maintenance and calibration of the mechanical storage
and counting device as recommended by the device’s
manufacturer; and
3. Routine quality assurance and accuracy validation testing
for each mechanical storage and counting device.
D. A pharmacy permittee or pharmacist-in-charge shall ensure
that the documentation required in subsection (C) is available
for inspection by the Board or its designee.
E. A pharmacy permittee or pharmacist-in-charge shall:
1. Ensure that policies and procedures for the performance
and use of a mechanical storage and counting device for a
drug in a solid, oral dosage form are prepared, imple-
mented, and complied with;
2. Review biennially and, if necessary, revise the policies
and procedures required under subsection (E)(1);
3. Document the review required under subsection (E)(2);
4. Assemble the policies and procedures as a written or elec-
tronic manual; and
5. Make the policies and procedures available within the
pharmacy for employee reference and inspection by the
Board or its staff.
F. The Board may prohibit a pharmacy permittee or pharmacist-
in-charge from using a mechanical storage and counting
device for a drug in a solid, oral dosage form if the pharmacy
permittee or the pharmacy permittee’s employees do not com-
ply with the requirements of subsections (A), (B), (C), (D), or
(E).
G. Returning a drug previously counted by a mechanical storage
and counting device for a drug in a solid, oral dosage form that
has not left the pharmacy to the drug’s cell or cassette.
1. Before returning a drug previously counted by a mechan-
ical storage and counting device that has not left the phar-
macy to the drug’s cell or cassette, a pharmacy permittee
or pharmacist-in-charge shall:
a. Apply for approval from the Board or its designee
for the drug return method to be used in returning
the drug;
b. Develop a drug return method that uses technology,
such as bar coding, to prevent drug return errors;
c. Provide documentation depicting the drug return
method;
d. Demonstrate the drug return method for a Board
Compliance Officer; and
e. Receive approval from the Board or its designee for
the drug return method to be used in returning the
drug.
2. Before approving a request to waive the drug return pro-
hibition in subsection (B), the Board or its designee shall:
a. Receive a request in writing from the pharmacy per-
mittee or pharmacist-in-charge;
b. Review the documentation of the drug return
method; and
c. Receive a satisfactory inspection report from a
Board Compliance Officer that the drug return
method uses technology to prevent drug return
errors.
Historical Note
New Section made by final rulemaking at 13 A.A.R. 616,
effective April 7, 2007 (Supp. 07-1). Amended by final
rulemaking at 14 A.A.R. 3677, effective November 8,
2008 (Supp. 08-3).
R4-23-616. Mechanical Counting Device for a Drug in Solid,
Oral Dosage Form
A. A pharmacy permittee or pharmacist-in-charge shall ensure
the accuracy of any mechanical counting device for a drug in a
solid, oral dosage form that is used by a pharmacist or a phar-
macy intern, graduate intern, pharmacy technician, or phar-
macy technician trainee under the supervision of a pharmacist
by documenting completion of the following:
1. Training in the maintenance, calibration, and use of the
mechanical counting device for each employee who uses
the mechanical counting device;
2. Maintenance and calibration of the mechanical counting
device as recommended by the device’s manufacturer;
and
3. Routine quality assurance and accuracy validation testing
for each mechanical counting device.
B. A pharmacy permittee or pharmacist-in-charge shall ensure
that the documentation required in subsection (A) is available
for inspection by the Board or its designee.
C. A pharmacy permittee or pharmacist-in-charge shall:
1. Ensure that policies and procedures for the performance
and use of a mechanical counting device for a drug in a
solid, oral dosage form are prepared, implemented, and
complied with;
2. Review biennially and, if necessary, revise the policies
and procedures required under subsection (C)(1);
3. Document the review required under subsection (C)(2);
4. Assemble the policies and procedures as a written or elec-
tronic manual; and
5. Make the policies and procedures available within the
pharmacy for employee reference and inspection by the
Board or its staff.
D. The Board may prohibit a pharmacy permittee or pharmacist-
in-charge from using a mechanical counting device for a drug
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 53
in a solid, oral dosage form if the pharmacy permittee or the
pharmacy permittee’s employees do not comply with the
requirements of subsections (A), (B), or (C).
Historical Note
New Section made by final rulemaking at 13 A.A.R. 616,
effective April 7, 2007 (Supp. 07-1).
R4-23-617. Temporary Pharmacy Facilities or Mobile Phar-
macies
A. Pharmacies located in declared disaster areas, nonresident
pharmacies, and pharmacies licensed or permitted in another
state but not licensed or permitted in this state, if necessary to
provide pharmacy services during a declared state of emer-
gency, may arrange to temporarily locate to a temporary phar-
macy facility or mobile pharmacy or relocate to a temporary
pharmacy facility or mobile pharmacy if the pharmacist-in-
charge of the temporary pharmacy facility or mobile pharmacy
ensures that:
1. The pharmacy is under the control and management of
the pharmacist-in-charge or a supervising pharmacist des-
ignated by the pharmacist-in-charge;
2. The pharmacy is located within or adjacent to the
declared disaster area;
3. The Board is notified of the pharmacy’s location;
4. The pharmacy is properly secured to prevent theft and
diversion of drugs;
5. The pharmacy’s records are maintained in accordance
with Arizona statutes and rules; and
6. The pharmacy stops providing pharmacy services when
the declared state of emergency ends, unless it possesses
a current resident pharmacy permit issued by the Board
under A.R.S. §§ 32-1929, 32-1930, and 32-1931.
B. The Board shall have the authority to approve or deny tempo-
rary pharmacy facilities, mobile pharmacies, and shall make
arrangements for appropriate monitoring and inspection of the
temporary pharmacy facilities and mobile pharmacies on a
case-by-case basis.
C. A temporary pharmacy facility wishing to permanently oper-
ate at its temporary site shall apply for and have received a
permit issued under A.R.S. §§ 32-1929, 32-1930, and 32-1931
by following the application process under R4-23-606.
D. A mobile pharmacy, placed in operation during a declared
state of emergency, shall not operate permanently.
Historical Note
New Section made by final rulemaking at 14 A.A.R.
4400, effective January 3, 2009 (Supp. 08-4).
R4-23-618. Reserved
R4-23-619. Reserved
R4-23-620. Continuous Quality Assurance Program
A. Each pharmacy permittee shall implement or participate in a
continuous quality assurance (CQA) program. A pharmacy
permittee meets the requirements of this Section if it holds a
current general, special or rural general hospital license from
the Arizona Department of Health Services and is any of the
following:
1. Certified by the Centers for Medicare and Medicaid Ser-
vices to participate in the Medicare or Medicaid pro-
grams;
2. Accredited by the Joint Commission on the Accreditation
of Healthcare Organizations; or
3. Accredited by the American Osteopathic Association.
B. A pharmacy permittee or the pharmacist-in-charge shall
ensure that:
1. The pharmacy develops, implements, and utilizes a CQ
program consistent with the requirements of this Section
and A.R.S. § 32-1973;
2. The medication error data generated by the CQA program
is utilized and reviewed on a regular basis, as required by
subsection (D); and
3. Training records, policies and procedures, and other pro-
gram records or documents, other than medication error
data, are maintained for a minimum of two years in the
pharmacy or in a readily retrievable manner.
C. A pharmacy permittee or pharmacist-in-charge shall:
1. Ensure that policies and procedures for the operation and
management of the pharmacy’s CQA program are pre-
pared, implemented, and complied with;
2. Review biennially and, if necessary, revise the policies
and procedures required under subsection (C)(1);
3. Document the review required under subsection (C)(2);
4. Assemble the policies and procedures as a written or elec-
tronic manual; and
5. Make the policies and procedures available within the
pharmacy for employee reference and inspection by the
Board or its staff.
D. The policies and procedures shall address a planned process
to:
1. Train all pharmacy personnel in relevant phases of the
CQA program;
2. Identify and document medication errors;
3. Record, measure, and analyze data collected to:
a. Assess the causes and any contributing factors relat-
ing to medication errors, and
b. Improve the quality of patient care;
4. Utilize the findings from subsections (D)(2) and (3) to
develop pharmacy systems and workflow processes
designed to prevent or reduce medication errors; and
5. Communicate periodically, and at least annually, with
pharmacy personnel to review CQA program findings
and inform pharmacy personnel of any changes made to
pharmacy policies, procedures, systems, or processes as a
result of CQA program findings.
E. The Board’s regulatory oversight activities regarding a phar-
macy’s CQA program are limited to inspection of the phar-
macy’s CQA policies and procedures and enforcing the
pharmacy’s compliance with those policies and procedures.
F. A pharmacy’s compliance with this Section shall be consid-
ered by the Board as a mitigating factor in the investigation
and evaluation of a medication error.
Historical Note
New Section made by final rulemaking at 18 A.A.R.
2603, effective December 2, 2012 (Supp. 12-4).
R4-23-621. Shared Services
A. Before participating in shared services, a pharmacy shall have
either a current resident or non-resident pharmacy permit
issued by the Board.
B. A pharmacy may provide or utilize shared services functions
only if the pharmacies involved:
1. Have the same owner, or
2. Have a written contract or agreement that outlines the ser-
vices provided and the shared responsibilities of each
party in complying with federal and state pharmacy stat-
utes and rules, and
3. Share a common electronic file or technology that allows
access to information necessary or required to perform
shared services in conformance with the pharmacy act
and the Board’s rules.
C. Notifications to patients.
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 54 Supp. 20-1 March 31, 2020
1. Before using shared services provided by another phar-
macy, a pharmacy permittee shall:
a. Notify patients that their orders may be processed or
filled by another pharmacy; and
b. Provide the name of that pharmacy or, if the phar-
macy is part of a network of pharmacies under com-
mon ownership and any of the network pharmacies
may process or fill the order, notify the patient of
this fact. The notification may be provided through a
one-time written notice to the patient or through use
of a sign in the pharmacy.
2. If an order is delivered directly to the patient by a filling
pharmacy and not returned to the requesting pharmacy,
the filling pharmacy permittee shall ensure that the fol-
lowing is placed on the prescription container or on a sep-
arate sheet delivered with the prescription container:
a. The local, and if applicable, the toll-free telephone
number of the pharmacy utilizing shared services
that has access to the patient’s records; and
b. A statement that conveys to the patient or patient’s
care-giver the following information: “Written infor-
mation about this prescription has been provided for
you. Please read this information before you take the
medication. If you have questions concerning this
prescription, a pharmacist is available during normal
business hours to answer these questions at (insert
the local and toll-free telephone numbers of the
pharmacy utilizing shared services that has access to
the patient’s records).”
3. The provisions of subsection (C) do not apply to orders
delivered to patients in facilities where a licensed health
care professional is responsible for administering the pre-
scription medication to the patient.
D. A pharmacy permittee engaged in shared services shall:
1. Maintain manual or electronic records that identify, indi-
vidually for each order processed, the name, initials, or
identification code of each pharmacist, graduate intern,
pharmacy intern, pharmacy technician, and pharmacy
technician trainee who took part in the order interpreta-
tion, order entry verification, drug utilization review,
drug compatibility and drug allergy review, final order
verification, therapeutic intervention, or refill authoriza-
tion functions performed at that pharmacy;
2. Maintain manual or electronic records that identify, indi-
vidually for each order filled or dispensed, the name, ini-
tials, or identification code of each pharmacist, graduate
intern, pharmacy intern, pharmacy technician, and phar-
macy technician trainee who took part in the filling, dis-
pensing, and counseling functions performed at that
pharmacy;
3. Report to the Board as soon as practical the results of any
disciplinary action taken by another state’s pharmacy reg-
ulatory agency involving shared services;
4. Maintain a mechanism for tracking the order during each
step of the processing and filling procedures performed at
the pharmacy;
5. Provide for adequate security to protect the confidential-
ity and integrity of patient information; and
6. Provide for inspection of any required record or informa-
tion within 72 hours of any request by the Board or its
designee.
E. Each pharmacy permittee that provides or utilizes shared ser-
vices shall develop, implement, review, revise, and comply
with joint policies and procedures for shared services in the
manner described in R4-23-610(A)(2). Each pharmacy permit-
tee is required to maintain only those portions of the joint poli-
cies and procedures that relate to that pharmacy’s operations.
The policies and procedures shall:
1. Outline the responsibilities of each of the pharmacies;
2. Include a list of the name, address, telephone numbers,
and all license and permit numbers of the pharmacies
involved in shared services; and
3. Include policies and procedures for:
a. Notifying patients that their orders may be processed
or filled by another pharmacy and providing the
name of that pharmacy;
b. Protecting the confidentiality and integrity of patient
information;
c. Dispensing orders when the filled order is not
received or the patient comes in before the order is
received;
d. Maintaining required manual or electronic records to
identify the name, initials, or identification code and
specific activity or activities of each pharmacist,
graduate intern, pharmacy intern, pharmacy techni-
cian, or pharmacy technician trainee who performed
any shared services;
e. Complying with federal and state laws; and
f. Operating a continuous quality improvement pro-
gram for shared services, designed to objectively
and systematically monitor and evaluate the quality
and appropriateness of patient care, pursue opportu-
nities to improve patient care, and resolve identified
problems.
F. Nothing in this Section shall prohibit an individual pharmacist
licensed in Arizona, who is an employee of or under contract
with a pharmacy, or an Arizona-licensed graduate intern, phar-
macy intern, pharmacy technician, or pharmacy technician
trainee, working under the supervision of the pharmacist, from
accessing that pharmacy’s electronic database from inside or
outside the pharmacy and performing the order processing
functions permitted by the pharmacy act, if both of the follow-
ing conditions are met:
1. The pharmacy establishes controls to protect the confi-
dentiality and integrity of patient information; and
2. None of the database is duplicated, downloaded, or
removed from the pharmacy’s electronic database.
Historical Note
New Section made by final rulemaking at 13 A.A.R. 520,
effective April 7, 2007 (Supp. 07-1). Amended by final
rulemaking at 19 A.A.R. 97, effective March 10, 2013
(Supp. 13-1).
R4-23-622. Reserved
R4-23-623. Reserved
R4-23-624. Reserved
R4-23-625. Reserved
R4-23-626. Reserved
R4-23-627. Reserved
R4-23-628. Reserved
R4-23-629. Reserved
R4-23-630. Reserved
R4-23-631. Reserved
R4-23-632. Reserved
R4-23-633. Reserved
R4-23-634. Reserved
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 55
R4-23-635. Reserved
R4-23-636. Reserved
R4-23-637. Reserved
R4-23-638. Reserved
R4-23-639. Reserved
R4-23-640. Reserved
R4-23-641. Reserved
R4-23-642. Reserved
R4-23-643. Reserved
R4-23-644. Reserved
R4-23-645. Reserved
R4-23-646. Reserved
R4-23-647. Reserved
R4-23-648. Reserved
R4-23-649. Reserved
R4-23-650. Reserved
R4-23-651. Definitions
The following definitions apply to R4-23-651 through R4-23-659:
“Administration” means the giving of a dose of medication to
a patient as a result of an order of a medical practitioner.
“Direct copy” means an electronic, facsimile or carbonized
copy.
“Dispensing for hospital inpatients” means the interpreting,
evaluating, and implementing a medication order including
preparing for delivery a drug or device to an inpatient or inpa-
tient’s agent in a suitable container appropriately labeled for
subsequent administration to, or use by, an inpatient (hereafter
referred to as “dispensing”).
“Drug distribution” means the delivery of drugs other than
“administering” or “dispensing.”
“Emergency medical situation” means a condition of emer-
gency in which immediate drug therapy is required for the
preservation of health, life, or limb of a person or persons.
“Floor stock” means a supply of essential drugs not labeled for
a specific patient and maintained and controlled by the phar-
macy at a patient care area for the purpose of timely adminis-
tration to a patient of the hospital.
“Formulary” means a continually revised compilation of phar-
maceuticals (including ancillary information) that reflects the
current clinical judgment of the medical staff.
“Hospital pharmacy” means a pharmacy, as defined in A.R.S.
§ 32-1901, that holds a current permit issued by the Board pur-
suant to A.R.S. § 32-1931, and is located in a hospital as
defined in A.R.S. § 32-1901.
“Inpatient” means any patient who receives non-self-adminis-
tered drugs from a hospital pharmacy for use while within a
facility owned by the hospital.
“Intravenous admixture” means a sterile parenteral solution to
which one or more additional drug products have been added.
“Medication order” means a written, electronic, or verbal
order from a medical practitioner or a medical practitioner’s
authorized agent for administration of a drug or device.
“On-call” means a pharmacist is available to:
Consult or provide drug information regarding drug ther-
apy or related issues; or
Dispense a medication order and review a patient’s medi-
cation order for pharmaceutical and therapeutic feasibil-
ity under R4-23-653(E)(2) before any drug is
administered to a patient, except as specified in R4-23-
653(E)(1).
“Patient care area” means any area for the primary purpose of
providing a physical environment that is owned by or operated
in conjunction with a hospital, for a patient to obtain health
care services, except those areas where a physician, dentist,
veterinarian, osteopath, or other medical practitioner engages
primarily in private practice.
“Repackaged drug” means a drug product that is transferred by
pharmacy personnel from an original manufacturer’s container
to another container properly labeled for subsequent dispens-
ing.
“Satellite pharmacy” means a work area in a hospital setting
under the direction of a pharmacist that is a remote extension
of a centrally licensed hospital pharmacy and owned by and
dependent upon the centrally licensed hospital pharmacy for
administrative control, staffing, and drug procurement.
“Single unit” means a package of medication that contains one
discrete pharmaceutical dosage form.
“Supervision” means the process by which a pharmacist
directs the activities of hospital pharmacy personnel to a suffi-
cient degree to ensure that all activities are performed accu-
rately, safely, and without risk of harm to patients.
Historical Note
Former Rules 6.7110, 6.7120, and 6.7130; Amended
effective August 10, 1978 (Supp. 78-4). Amended sub-
section (B) effective April 20, 1982 (Supp. 82-2). Section
repealed, new Section adopted effective February 7, 1990
(Supp. 90-1). Amended effective November 1, 1993
(Supp. 93-4). Amended effective April 5, 1996 (Supp.
96-2). Amended by final rulemaking at 8 A.A.R. 4902,
effective January 5, 2003 (Supp. 02-4).
R4-23-652. Hospital Pharmacy Permit
A. The following rules are applicable to all hospitals as defined
by A.R.S. § 32-1901 and hospital pharmacies as defined by
R4-23-651.
B. Before opening a hospital pharmacy, a person shall obtain a
pharmacy permit as specified in R4-23-602 and R4-23-606.
C. Discontinued hospitals. If a hospital license is discontinued by
the state Department of Health Services, the pharmacy permit-
tee or pharmacist-in-charge shall follow the procedures
described in R4-23-613 for discontinuing a pharmacy.
Historical Note
Former Rules 6.7210, 6.7220, 6.7230, 6.7231, 6.7232,
and 6.7233. Section repealed, new Section adopted effec-
tive February 7, 1990 (Supp. 90-1). Amended by final
rulemaking at 8 A.A.R. 4902, effective January 5, 2003
(Supp. 02-4).
R4-23-653. Personnel: Professional or Technician
A. Each hospital pharmacy shall be directed by a pharmacist who
is licensed to engage in the practice of pharmacy in Arizona
and is referred to as the Director of Pharmacy. The Director of
Pharmacy shall be the pharmacist-in-charge, as defined in
A.R.S. § 32-1901 or shall appoint a pharmacist-in-charge. The
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 56 Supp. 20-1 March 31, 2020
Director of Pharmacy and the pharmacist-in-charge, if a differ-
ent individual, shall:
1. Be responsible for all the activities of the hospital phar-
macy and for meeting the requirements of the Arizona
Pharmacy Act and these rules;
2. Ensure that the policies and procedures required by these
rules are prepared, implemented, and complied with;
3. Review biennially and, if necessary, revise the policies
and procedures required under these rules;
4. Document the review required under subsection (A)(3);
5. Assemble the policies and procedures as a written manual
or by another method approved by the Board or its desig-
nee; and
6. Make the policies and procedures available within the
pharmacy for employee reference and inspection by the
Board or its designee.
B. In all hospitals, a pharmacist shall be in the hospital during the
time the pharmacy is open for pharmacy services, except for
an extreme emergency as defined in R4-23-110. Pharmacy ser-
vices shall be provided for a minimum of 40 hours per week,
unless an exception for less than the minimum hours is made
upon written request by the hospital and with express permis-
sion of the Board or its designee.
C. In a hospital where the pharmacy is not open 24 hours per day
for pharmacy services, a pharmacist shall be “on-call” as
defined in R4-23-651 when the pharmacy is closed.
D. The Director of Pharmacy may be assisted by other personnel
approved by the Director of Pharmacy in order to operate the
pharmacy competently, safely, and adequately to meet the
needs of the hospital’s patients.
E. Pharmacists. A pharmacist or a pharmacy intern or graduate
intern under the supervision of a pharmacist shall perform the
following professional practices:
1. Verify a patient’s medication order before administration
of a drug to the patient, except:
a. In an emergency medical situation; or
b. In a hospital where the pharmacy is open less than
24 hours a day for pharmacy services, a pharmacist
shall verify a patient’s medication order within four
hours of the time the pharmacy opens for pharmacy
services;
2. Verify a medication order’s pharmaceutical and therapeu-
tic feasibility based upon:
a. The patient’s medical condition,
b. The patient’s allergies,
c. The pharmaceutical and therapeutic incompatibili-
ties, and
d. The recommended dosage limits;
3. Measure, count, pour, or otherwise prepare and package a
drug needed for dispensing, except a pharmacy techni-
cian or pharmacy technician trainee may measure, count,
pour, or otherwise prepare and package a drug needed for
dispensing under the supervision of a pharmacist accord-
ing to written policies and procedures approved by the
Board or its designee;
4. Compound, admix, combine, or otherwise prepare and
package a drug needed for dispensing, except a pharmacy
technician may compound, admix, combine, or otherwise
prepare and package a drug needed for dispensing under
the supervision of a pharmacist according to written poli-
cies and procedures approved by the Board or its desig-
nee;
5. Verify the accuracy, correct procedure, compounding,
admixing, combining, measuring, counting, pouring, pre-
paring, packaging, and safety of a drug prepared and
packaged by a pharmacy technician or pharmacy techni-
cian trainee according to subsections (E)(3) and (4) and
according to the policies and procedures in subsection
(G);
6. Supervise drug repackaging and check the completed
repackaged product as specified in R4-23-402(A);
7. Supervise training and education in aseptic technique and
drug incompatibilities for all personnel involved in the
admixture of parenteral products within the hospital phar-
macy;
8. Consult with the medical practitioner regarding the
patient’s drug therapy or medical condition;
9. When requested by a medical practitioner, patient,
patient’s agent, or when the pharmacist deems it neces-
sary, provide consultation with a patient regarding the
medication order, patient’s profile, or overall drug ther-
apy;
10. Monitor a patient’s drug therapy for safety and effective-
ness;
11. Provide drug information to patients and health care pro-
fessionals;
12. Manage the activities of pharmacy technicians, pharmacy
technician trainees, other personnel, and systems to
ensure that all activities are performed accurately, safely,
and without risk of harm to patients;
13. Verify the accuracy of all aspects of the original, com-
pleted medication order; and
14. Ensure compliance by pharmacy personnel with a quality
assurance program developed by the hospital.
F. Pharmacy technicians and pharmacy technician trainees.
Before working as a pharmacy technician or pharmacy techni-
cian trainee, an individual shall meet the eligibility and licen-
sure requirements prescribed in 4 A.A.C. 23, Article 11.
G. Pharmacy technician policies and procedures. Before employ-
ing a pharmacy technician or pharmacy technician trainee, a
Director of Pharmacy or pharmacist-in-charge shall develop
the policies and procedures required under R4-23-1104.
H. Pharmacy technician training program.
1. A Director of Pharmacy or pharmacist-in-charge shall
comply with the training program requirements of R4-23-
1105 based on the needs of the hospital pharmacy;
2. A pharmacy technician or pharmacy technician trainee
shall:
a. Perform only those tasks for which training and
competency have been demonstrated; and
b. Not perform professional practices reserved for a
pharmacist, graduate intern, or pharmacy intern in
subsection (E), except as specified in subsections
(E)(3) and (4).
I. Supervision. A hospital pharmacy’s Director of Pharmacy and
the pharmacist-in-charge, if a different individual, shall super-
vise all of the activities and operations of a hospital pharmacy.
A pharmacist shall supervise all functions and activities of
pharmacy technicians, pharmacy technician trainees, and other
hospital pharmacy personnel to ensure that all functions and
activities are performed competently, safely, and without risk
of harm to patients.
Historical Note
Former Rules 6.7310 and 6.7320; Amended effective
August 10, 1978 (Supp. 78-4). Section repealed, new
Section adopted effective February 7, 1990 (Supp. 90-1).
Amended effective November 1, 1993 (Supp. 93-4).
Amended by final rulemaking at 8 A.A.R. 4902, effective
January 5, 2003 (Supp. 02-4). Amended by final
rulemaking at 10 A.A.R. 1192, effective May 1, 2004
(Supp. 04-1). Amended by final rulemaking at 12 A.A.R.
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 57
3032, effective October 1, 2006 (Supp. 06-3).
R4-23-654. Absence of Pharmacist
A. If a pharmacist will not be on duty in the hospital, the Director
of Pharmacy or pharmacist-in-charge shall arrange, before the
pharmacist’s absence, for the medical staff and other autho-
rized personnel of the hospital to have access to drugs in the
remote drug storage area defined in R4-23-110 or in the hospi-
tal pharmacy if a drug is not available in a remote drug storage
area and is required to treat the immediate needs of a patient.
A pharmacist shall be on-call during all absences.
B. If a pharmacist will not be on duty in the hospital pharmacy,
the Director of Pharmacy or pharmacist-in-charge shall
arrange, before the pharmacist’s absence, for the medical staff
and other authorized personnel of the hospital to have tele-
phone access to an on-call pharmacist.
C. The hospital pharmacy permittee shall ensure that the hospital
pharmacy is not without a pharmacist on duty in the hospital
for more than 72 consecutive hours.
D. Remote drug storage area. The Director of Pharmacy or phar-
macist-in-charge shall, in consultation with the appropriate
committee of the hospital:
1. Develop and maintain an inventory listing of the drugs to
be included in a remote drug storage area; and
2. Develop, implement, review, and revise in the same man-
ner described in R4-23-653(A) and comply with policies
and procedures that ensure proper storage, access, and
accountability for drugs in a remote drug storage area.
E. Access to hospital pharmacy. If a drug is not available from a
remote drug storage area and the drug is required to treat the
immediate needs of a patient whose health may be compro-
mised, the drug may be obtained from the hospital pharmacy
according to the requirements of this subsection.
1. The Director of Pharmacy or pharmacist-in-charge shall,
in consultation with the appropriate committee of the hos-
pital, develop, implement, review, and revise in the same
manner described in R4-23-653(A) and comply with pol-
icies and procedures to ensure that access to the hospital
pharmacy during the pharmacist’s absence conforms to
the following requirements:
a. Access is delegated to only one supervisory nurse in
each shift;
b. The policy and name of supervisory nurse is com-
municated in writing to the medical staff of the hos-
pital;
c. Access is delegated only to a nurse who has received
training from the Director of Pharmacy, pharmacist-
in-charge, or Director’s designee in the procedures
required for proper access, drug removal, and
recordkeeping; and
d. Access is delegated by the supervisory nurse to
another nurse only in an emergency.
2. If a nurse to whom authority is delegated to access the
hospital pharmacy removes a drug from the hospital phar-
macy, the nurse shall:
a. Record the following information on a form or by
another method approved by the Board or its desig-
nee:
i. Patient’s name;
ii. Drug name, strength, and dosage form;
iii. Quantity of drug removed; and
iv. Date and time of removal;
b. Sign or initial, if a corresponding signature is on file
in the hospital pharmacy, the form recording the
drug removal;
c. Attach the original or a direct copy of the medication
order for the drug to the form recording the drug
removal; and
d. Place the form recording the drug removal conspicu-
ously in the hospital pharmacy.
3. Within four hours after a pharmacist returns from an
absence, the pharmacist shall verify all records of drug
removal that occurred during the pharmacist’s absence
according to R4-23-653(E).
Historical Note
Former Rules 6.7410, 6.7420, 6.7430, 6.7440, 6.7450,
and 6.7460; Amended subsection (A) effective Aug. 9,
1983 (Supp. 83-4). Section repealed, new Section
adopted effective February 7, 1990 (Supp. 90-1).
Amended by final rulemaking at 8 A.A.R. 4902, effective
January 5, 2003 (Supp. 02-4). Amended by final
rulemaking at 10 A.A.R. 1192, effective May 1, 2004
(Supp. 04-1). Amended by final rulemaking at 12 A.A.R.
3032, effective October 1, 2006 (Supp. 06-3).
R4-23-655. Physical Facility
A. General. A hospital pharmacy permittee shall ensure that the
hospital pharmacy has sufficient equipment and physical facil-
ities for proper compounding, dispensing, and storage of
drugs, including parenteral preparations.
B. Minimum area of hospital pharmacy. The minimum area of a
hospital pharmacy depends on the type of hospital, the number
of beds, and the pharmaceutical services provided. Any hospi-
tal pharmacy permit issued or hospital pharmacy remodeled
after January 31, 2003 shall provide a minimum hospital phar-
macy area, the actual area primarily devoted to drug dispens-
ing and preparation functions, exclusive of bulk drug storage,
satellite pharmacy, and office areas that is not less than 500
square feet. The minimum area requirement, not including
unusable area, may be varied upon approval by the Board for
out-of-the-ordinary conditions or for systems that require less
space.
C. The Board may also require that a hospital pharmacy permittee
or applicant provide:
1. More than the minimum area if equipment, inventory,
personnel, or other factors cause crowding to a degree
that interferes with safe pharmacy practice;
2. Additional dispensing, preparation, or storage areas
because of the increased number of specific drugs pre-
scribed per day, the increased use of intravenous and irri-
gating solutions, and the increased use of disposable and
prepackaged products;
3. Additional dispensing, preparation, or storage areas to
handle investigational drugs, emergency drug kits, che-
motherapeutics, alcohol and other flammables, poisons,
external preparations, and radioisotopes, and to accom-
modate quality control procedures; and
4. Additional office space to provide for an increased num-
ber of personnel, a drug information library, a poison
information library, research support, teaching and con-
ferences, and a waiting area.
D. Hospital pharmacy area. A hospital pharmacy permittee shall
ensure that the hospital pharmacy area is enclosed by a perma-
nent barrier or partition from floor to ceiling with entry doors
that can be securely locked, constructed according to R4-23-
609(F).
E. Hospital pharmacy storage areas. The hospital pharmacy per-
mittee, Director of Pharmacy, or pharmacist-in-charge shall
ensure that all undispensed or undistributed drugs are stored in
designated areas within the hospital pharmacy or other locked
areas under the control of a pharmacist that ensure proper san-
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 58 Supp. 20-1 March 31, 2020
itation, temperature, light, ventilation, moisture control, segre-
gation, and security.
Historical Note
Former Rules 6.7471, 6.7472, 6.7473, 6.7474, and
6.7490; Amended effective Aug. 9, 1983 (Supp. 83-4).
Section repealed, new Section adopted effective February
7, 1990 (Supp. 90-1). Correction to Table 1 (“spare feet”
changed to “square feet”) (Supp. 91-1). Amended by final
rulemaking at 8 A.A.R. 4902, effective January 5, 2003
(Supp. 02-4). Amended by final rulemaking at 11 A.A.R.
462, effective March 5, 2005 (Supp. 05-1).
R4-23-656. Sanitation and Equipment
A hospital pharmacy permittee or Director of Pharmacy shall
ensure that a hospital pharmacy:
1. Has a professional reference library consisting of hard-
copy or electronic media appropriate for the scope of
pharmacy services provided by the hospital;
2. Has a sink, other than a sink in a toilet facility, that:
a. Has hot and cold running water;
b. Is within the hospital pharmacy area for use in pre-
paring drug products; and
c. Is maintained in a sanitary condition and in good
repair;
3. Maintains a room temperature within a range compatible
with the proper storage of drugs;
4. Has a refrigerator and freezer with a temperature main-
tained within a range compatible with the proper storage
of drugs requiring refrigeration or freezing; and
5. Has a designated area for a laminar air flow hood and
other supplies required for the preparation of sterile prod-
ucts as specified in R4-23-670.
Historical Note
Former Rule 6.7480. Section repealed, new Section
adopted effective February 7, 1990 (Supp. 90-1).
Amended by final rulemaking at 8 A.A.R. 4902, effective
January 5, 2003 (Supp. 02-4).
R4-23-657. Security
A. Personnel security standards. A Director of Pharmacy shall
ensure that:
1. No one is permitted in the pharmacy unless a pharmacist
is present except as provided in this Section and R4-23-
654. If only one pharmacist is on duty in the pharmacy
and that pharmacist must leave the pharmacy for an emer-
gency or patient care duties, nonpharmacist personnel
may remain in the pharmacy to perform duties as outlined
in R4-23-653, provided that all C-II controlled substances
are secured to prohibit access by other than a pharmacist,
and that the pharmacist remains available in the hospital;
2. All hospital pharmacy areas are kept locked by key or
programmable lock to prevent access by unauthorized
personnel; and
3. Pharmacists, pharmacy or graduate interns, pharmacy
technicians, pharmacy technician trainees, and other per-
sonnel working in the pharmacy wear identification
badges, including name and position, whenever on duty.
B. Prescription blank security. The Director of Pharmacy shall
develop, implement, review, and revise in the same manner
described in R4-23-653(A) and comply with policies and pro-
cedures for the safe distribution and control of prescription
blanks bearing identification of the hospital.
Historical Note
Former Rule 6.7500; Amended effective Aug. 9, 1983
(Supp. 83-4). Section repealed, new Section adopted
effective February 7, 1990 (Supp. 90-1). Amended by
final rulemaking at 8 A.A.R. 4902, effective January 5,
2003 (Supp. 02-4). Amended by final rulemaking at 10
A.A.R. 1192, effective May 1, 2004 (Supp. 04-1).
Amended by final rulemaking at 12 A.A.R. 3032, effec-
tive October 1, 2006 (Supp. 06-3).
R4-23-658. Drug Distribution and Control
A. General. The Director of Pharmacy or pharmacist-in-charge
shall in consultation with the medical staff, develop, imple-
ment, review, and revise in the same manner described in R4-
23-653(A) and comply with written policies and procedures
for the effective operation of a drug distribution system that
optimizes patient safety.
B. Responsibility. The Director of Pharmacy is responsible for
the safe and efficient procurement, dispensing, distribution,
administration, and control of drugs, including the following:
1. In consultation with the appropriate department personnel
and medical staff committee, develop a medication for-
mulary for the hospital;
2. Proper handling, distribution, and recordkeeping of
investigational drugs; and
3. Regular inspections of drug storage and preparation areas
within the hospital.
C. Physician orders. A Director of Pharmacy or pharmacist-in-
charge shall ensure that:
1. Drugs are dispensed from the hospital pharmacy only
upon a written order, direct copy or facsimile of a written
order, or verbal order of an authorized medical practi-
tioner; and
2. A pharmacist reviews the original, direct or facsimile
copy, or verbal order before an initial dose of medication
is administered, except as specified in R4-23-653(E)(1).
D. Labeling. A Director of Pharmacy or pharmacist-in-charge
shall ensure that all drugs distributed or dispensed by a hospi-
tal pharmacy are packaged in appropriate containers and
labeled as follows:
1. For use inside the hospital.
a. Labels for all single unit packages contain at a mini-
mum, the following information:
i. Drug name, strength, and dosage form;
ii. Lot number and beyond-use-date; and
iii. Appropriate auxiliary labels;
b. Labels for repackaged preparations contain at a min-
imum the following information:
i. Drug name, strength, and dosage form;
ii. Lot number and beyond-use-date;
iii. Appropriate auxiliary labels; and
iv. Mechanism to identify pharmacist accountable
for repackaging;
c. Labels for all intravenous admixture preparations
contain at a minimum the following information:
i. Patient’s name and location;
ii. Name and quantity of the basic parenteral solu-
tion;
iii. Name and amount of drug added;
iv. Date of preparation;
v. Beyond-use-date and time;
vi. Guidelines for administration;
vii. Appropriate auxiliary label or precautionary
statement; and
viii. Initials of pharmacist responsible for admixture
preparation; and
2. For use outside the hospital. Any drug dispensed to a
patient by a hospital pharmacy that is intended for self-
administration outside of the hospital is labeled as speci-
fied in A.R.S. §§ 32-1963.01(C) and 32-1968(D) and
A.A.C. R4-23-402.
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 59
E. Controlled substance accountability. A Director of Pharmacy
or pharmacist-in-charge shall ensure that effective policies and
procedures are developed, implemented, reviewed, and
revised in the same manner described in R4-23-653(A) and
complied with regarding the use, accountability, and record-
keeping of controlled substances in the hospital, including the
use of locked storage areas when controlled substances are
stored in patient care areas.
F. Emergency services dispensing. If a hospital permits dispens-
ing of drugs from the emergency services department when the
pharmacy is unable to provide this service, the Director of
Pharmacy, in consultation with the appropriate department
personnel and medical staff committee shall develop, imple-
ment, review, and revise in the same manner described in R4-
23-653(A) and comply with written policies and procedures
for dispensing drugs for outpatient use from the hospital’s
emergency services department. The policies and procedures
shall include the following requirements:
1. Drugs are dispensed only to patients who have been
admitted to the emergency services department;
2. Drugs are dispensed only by an authorized medical prac-
titioner, not a designee or agent;
3. The nature and type of drugs available for dispensing are
designed to meet the immediate needs of the patients
treated within the hospital;
4. Drugs are dispensed only in quantities sufficient to meet
patient needs until outpatient pharmacy services are
available;
5. Drugs are prepackaged by a pharmacist or a pharmacy
intern, graduate intern, pharmacy technician, or phar-
macy technician trainee under the supervision of a phar-
macist in suitable containers and appropriately prelabeled
with the drug name, strength, dosage form, quantity, man-
ufacturer, lot number, beyond-use-date, and any appropri-
ate auxiliary labels;
6. Upon dispensing, the authorized medical practitioner
completes the label on the prescription container that
complies with the requirements of R4-23-658(D); and
7. The hospital pharmacy maintains a dispensing log, hard-
copy prescription, or electronic record, approved by the
Board or its designee and includes the patient name and
address, drug name, strength, dosage form, quantity,
directions for use, medical practitioner’s signature or
identification code, and DEA registration number, if
applicable.
Historical Note
Former Rules 6.7610, 6.7620, and 6.7710; Amended
effective Aug. 9, 1983 (Supp. 83-4). Section repealed,
new Section adopted effective February 7, 1990 (Supp.
90-1). Correction to subsection (I)(5) (“unnecessary”
changed to “necessary”) (Supp. 91-1). Amended effective
November 1, 1993 (Supp. 93-4). Amended by final
rulemaking at 8 A.A.R. 4902, effective January 5, 2003
(Supp. 02-4). Amended by final rulemaking at 10 A.A.R.
1192, effective May 1, 2004 (Supp. 04-1). Amended by
final rulemaking at 12 A.A.R. 3032, effective October 1,
2006 (Supp. 06-3).
R4-23-659. Administration of Drugs
A. Self-administration. A hospital shall not allow self-administra-
tion of medications by a patient unless the Director of Phar-
macy or pharmacist-in-charge, in consultation with the
appropriate department personnel and medical staff commit-
tee, develops, implements, reviews, and revises in the same
manner described in R4-23-653(A) and complies with policies
and procedures for self-administration of medications by a
patient. The policies and procedures shall specify that self-
administration of medications, if allowed, occurs only when:
1. Specifically ordered by a medical practitioner, and
2. The patient is educated and trained in the proper manner
of self-administration.
B. Drugs brought in by a patient. If a hospital allows a patient to
bring a drug into the hospital and before a patient brings a drug
into the hospital, the Director of Pharmacy or pharmacist-in-
charge shall, in consultation with the appropriate department
personnel and medical staff committee, develop, implement,
review, and revise in the same manner described in R4-23-
653(A) and comply with policies and procedures for a patient-
owned drug brought into the hospital. The policies and proce-
dures shall specify the following criteria for a patient-owned
drug brought into the hospital:
1. When policy allows the administration of a patient-
owned drug, the drug is not administered to the patient
unless:
a. A pharmacist or medical practitioner identifies the
drug, and
b. A medical practitioner writes a medication order
specifying administration of the identified patient-
owned drug; and
2. If a patient-owned drug will not be used during the
patient’s hospitalization, the hospital pharmacy’s person-
nel shall:
a. Package, seal, and give the drug to the patient’s
agent for removal from the hospital; or
b. Package, seal, and store the drug for return to the
patient at the time of discharge from the hospital.
C. Drug samples. The Director of Pharmacy or pharmacist-in-
charge is responsible for the receipt, storage, distribution, and
accountability of drug samples within the hospital, including
developing, implementing, reviewing, and revising in the
same manner described in R4-23-653(A) and complying with
specific policies and procedures regarding drug samples.
Historical Note
Former Rules 6.7720, 6.7730, 6.7740, 6.7760, 6.7770,
6.7780, 6.7800, 6.7810, 6.7820, 6.7830, 6.7840, 6.7850,
6.7871, 6.7872, and 6.7873; Amended effective Aug. 9,
1983 (Supp. 83-4). Section repealed, new Section
adopted effective February 7, 1990 (Supp. 90-1). Correc-
tion to Section heading (“rules” changed to “roles”)
(Supp. 91-1). Section repealed; new Section made by
final rulemaking at 8 A.A.R. 4902, effective January 5,
2003 (Supp. 02-4). Amended by final rulemaking at 10
A.A.R. 1192, effective May 1, 2004 (Supp. 04-1).
Amended by final rulemaking at 12 A.A.R. 3032, effec-
tive October 1, 2006 (Supp. 06-3).
R4-23-660. Investigational Drugs
The Director of Pharmacy or pharmacist-in-charge shall ensure
that:
1. The following information concerning an investigational
drug is available for use by hospital personnel:
a. Composition,
b. Pharmacology,
c. Adverse reactions,
d. Administration guidelines, and
e. All other available information concerning the drug,
and
2. An investigational drug is:
a. Properly stored in, labeled, and dispensed from the
pharmacy, and
b. Not dispensed before the drug is approved by the
appropriate medical staff committee of the hospital.
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 60 Supp. 20-1 March 31, 2020
Historical Note
Former Rules 6.7881, 6.7882, and 6.7883; Amended sub-
section (A) effective Aug. 9, 1983 (Supp. 83-4).
Repealed, new Section adopted effective February 7,
1990 (Supp. 90-1). Section repealed; new Section made
by final rulemaking at 8 A.A.R. 4902, effective January
5, 2003 (Supp. 02-4).
R4-23-661. Repealed
Historical Note
Former Rules 6.7910, 6.7920, 6.7930, 6.7940, and
6.7950. Section repealed, new Section adopted effective
February 7, 1990 (Supp. 90-1). Section repealed by final
rulemaking at 8 A.A.R. 4902, effective January 5, 2003
(Supp. 02-4).
R4-23-662. Repealed
Historical Note
Adopted effective February 7, 1990 (Supp. 90-1). Section
repealed by final rulemaking at 8 A.A.R. 4902, effective
January 5, 2003 (Supp. 02-4).
R4-23-663. Repealed
Historical Note
Adopted effective February 7, 1990 (Supp. 90-1).
Amended effective November 1, 1993 (Supp. 93-4). Sec-
tion repealed by final rulemaking at 8 A.A.R. 4902, effec-
tive January 5, 2003 (Supp. 02-4).
R4-23-664. Repealed
Historical Note
Adopted effective February 7, 1990 (Supp. 90-1). Sub-
section label removed (Supp. 91-1). Section repealed by
final rulemaking at 8 A.A.R. 4902, effective January 5,
2003 (Supp. 02-4).
R4-23-665. Reserved
R4-23-666. Reserved
R4-23-667. Reserved
R4-23-668. Reserved
R4-23-669. Reserved
R4-23-670. Sterile Pharmaceutical Products
A. In addition to the minimum area requirement of R4-23-609(A)
and R4-23-655(B) and before compounding a sterile pharma-
ceutical product, a pharmacy permittee, limited-service phar-
macy permittee, or applicant shall provide a minimum sterile
pharmaceutical product compounding area that is not less than
100 square feet of contiguous floor area, except any pharmacy
permit issued or pharmacy remodeled before November 1,
2006 may continue to use a sterile pharmaceutical product
compounding area that is not less that 60 square feet of contig-
uous floor area, until a pharmacy ownership change occurs
that requires issuance of a new permit or the pharmacy is
remodeled. The pharmacy permittee or the pharmacist-in-
charge shall ensure that the sterile pharmaceutical product
compounding area:
1. Is dedicated to the purpose of preparing and compound-
ing sterile pharmaceutical products;
2. Is isolated from other pharmacy functions;
3. Restricts entry or access;
4. Is free from unnecessary disturbances in air flow;
5. Is made of non-porous and cleanable floor, wall, and ceil-
ing material; and
6. Meets the minimum air cleanliness standards of an ISO
Class 7 environment as defined in R4-23-110, except an
ISO class 7 environment is not required if all sterile phar-
maceutical product compounding occurs within an ISO
class 5 environment isolator, such as a glove box, phar-
maceutical isolator, barrier isolator, pharmacy isolator, or
hospital pharmacy isolator.
B. In addition to the equipment requirements in R4-23-611 and
R4-23-612 or R4-23-656 and before compounding a sterile
pharmaceutical product, a pharmacy permittee, limited-service
pharmacy permittee, or applicant shall ensure that a pharma-
cist who compounds a sterile pharmaceutical product has the
following equipment:
1. Environmental control devices capable of maintaining a
compounding area environment equivalent to an “ISO
class 5 environment” as defined in R4-23-110. Devices
capable of meeting these standards include: laminar air-
flow hoods, hepa filtered zonal airflow devices, glove
boxes, pharmaceutical isolators, barrier isolators, phar-
macy isolators, hospital pharmacy isolators, and biologi-
cal safety cabinets;
2. Disposal containers designed for needles, syringes, and
other material used in compounding sterile pharmaceuti-
cal products and if applicable, separate containers to dis-
pose of cytotoxic, chemotherapeutic, and infectious waste
products;
3. Freezer storage units with thermostatic control and ther-
mometer, if applicable;
4. Packaging or delivery containers capable of maintaining
official compendial drug storage conditions;
5. Infusion devices and accessories, if applicable; and
6. In addition to the reference library requirements of R4-
23-612, a current reference pertinent to the preparation of
sterile pharmaceutical products.
C. Before compounding a sterile pharmaceutical product, the
pharmacy permittee, limited-service pharmacy permittee, or
pharmacist-in-charge shall:
1. Prepare, implement, and comply with policies and proce-
dures for compounding and dispensing sterile pharma-
ceutical products,
2. Review biennially and if necessary revise the policies and
procedures required under subsection (C)(1),
3. Document the review required under subsection (C)(2),
4. Assemble the policies and procedures as a written manual
or by another method approved by the Board or its desig-
nee, and
5. Make the policies and procedures available in the phar-
macy for employee reference and inspection by the Board
or its designee.
D. The assembled policies and procedures shall include, where
applicable, the following subjects:
1. Supervisory controls and verification procedures to
ensure the quality and safety of sterile pharmaceutical
products;
2. Clinical services and drug monitoring procedures for:
a. Patient drug utilization reviews;
b. Inventory audits;
c. Patient outcome monitoring;
d. Drug information; and
e. Education of pharmacy and other health profession-
als;
3. Controlled substances;
4. Supervisory controls and verification procedures for:
a. Cytotoxics handling, storage, and disposal;
b. Disposal of unused supplies and pharmaceutical
products; and
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 61
c. Handling and disposal of infectious wastes;
5. Pharmaceutical product administration, including guide-
lines for the first dosing of a pharmaceutical product;
6. Drug and component procurement;
7. Pharmaceutical product compounding, dispensing, and
storage;
8. Duties and qualifications of professional and support
staff;
9. Equipment maintenance;
10. Infusion devices and pharmaceutical product delivery
systems;
11. Investigational drugs and their protocols;
12. Patient profiles;
13. Patient education and safety;
14. Quality management procedures for:
a. Adverse drug reactions;
b. Drug recalls;
c. Expired pharmaceutical products;
d. Beyond-use-dating for both standard-risk and sub-
stantial-risk sterile pharmaceutical products consis-
tent with the requirements of R4-23-410(B)(3)(d);
e. Temperature and other environmental controls;
f. Documented process and product validation testing;
and
g. Semi-annual certification of the laminar air flow
hood or other ISO class 5 environment, other equip-
ment, and the ISO class 7 environment, including
documentation of routine cleaning and maintenance
for each laminar air flow hood or other ISO class 5
environment, other equipment, and the ISO class 7
environment; and
15. Sterile pharmaceutical product delivery requirements for:
a. Shipment to the patient;
b. Security; and
c. Maintaining official compendial storage conditions.
E. Standard-risk sterile pharmaceutical product compounding.
Before compounding a standard-risk sterile pharmaceutical
product, a pharmacy permittee or pharmacist-in-charge shall
ensure compliance with the following minimum standards:
1. Compounding occurs only in an ISO class 5 environment
within an ISO class 7 environment, and the ISO class 7
environment may have a specified prep area inside the
environment;
2. Compounding sterile pharmaceutical products from ster-
ile commercial drugs or sterile pharmaceutical otic or
ophthalmic products from non-sterile ingredients occurs
using procedures that involve only a few closed-system,
basic, simple aseptic transfers and manipulations;
3. Each person who compounds wears adequate personnel
protective clothing for sterile preparation that includes
gown, gloves, head cover, and booties. Each person who
compounds is not required to wear personnel protective
clothing when all sterile pharmaceutical compounding
occurs within an ISO class 5 environment isolator, and
the ISO Class 5 environment isolator is not inside an ISO
Class 7 environment; and
4. Each person who compounds completes an annual media-
fill test to validate proper aseptic technique.
F. Substantial-risk sterile pharmaceutical product compounding.
Before compounding a substantial-risk sterile pharmaceutical
product, a pharmacy permittee or pharmacist-in-charge shall
ensure compliance with the following minimum standards:
1. Compounding parenteral or injectable sterile pharmaceu-
tical products from non-sterile ingredients occurs only in
an ISO class 5 environment within an ISO class 7 envi-
ronment and the ISO class 7 environment shall not have a
prep area inside the environment;
2. Each person who compounds wears adequate personnel
protective clothing for sterile preparation that includes
gown, gloves, head cover, and booties. Each person who
compounds is not required to wear personnel protective
clothing when all sterile pharmaceutical compounding
occurs within an ISO class 5 environment isolator, and
the ISO Class 5 environment isolator is not inside an ISO
Class 7 environment; and
3. Each person who compounds completes a semi-annual
media-fill test that simulates the most challenging or
stressful conditions for compounding using dry non-ster-
ile media to validate proper aseptic technique.
Historical Note
Adopted effective November 1, 1993 (Supp. 93-4).
Amended by final rulemaking at 10 A.A.R. 3391, effec-
tive October 2, 2004 (Supp. 04-3). Amended by final
rulemaking at 12 A.A.R. 3981, effective December 4,
2006 (Supp. 06-4).
R4-23-671. General Requirements for Limited-service Phar-
macy
A. Before opening a limited-service pharmacy, a person shall
obtain a permit in compliance with A.R.S. §§ 32-1929, 32-
1930, 32-1931, and R4-23-606.
B. The limited-service pharmacy permittee shall secure the lim-
ited-service pharmacy by conforming with the following stan-
dards:
1. Permit no one to be in the limited-service pharmacy
unless the pharmacist-in-charge or a pharmacist autho-
rized by the pharmacist-in-charge is present;
2. Require the pharmacist-in-charge to designate in writing,
by name, title, and specific area, those persons who will
have access to particular areas of the limited-service
pharmacy;
3. Implement procedures to guard against theft or diversion
of drugs, including controlled substances; and
4. Require all persons working in the limited-service phar-
macy to wear badges, with their names and titles, while
on duty.
C. To obtain permission to deviate from the minimum area
requirement set forth in R4-23-609, R4-23-673, or R4-23-682,
a limited-service pharmacy permittee shall submit a written
request to the Board and include documentation that the devia-
tion will facilitate experimentation or technological advances
in the practice of pharmacy as defined in A.R.S. § 32-1901. If
the Board determines the requested deviation from the mini-
mum area requirement will enhance the practice of pharmacy
and benefit the public, the Board shall grant the requested
deviation.
D. The Board shall require more than the minimum area in a lim-
ited-service pharmacy when the Board determines that equip-
ment, personnel, or other factors in the limited-service
pharmacy cause crowding that interferes with safe pharmacy
practice.
E. Before dispensing from a limited-service pharmacy, the lim-
ited-service pharmacy permittee or pharmacist-in-charge shall:
1. Prepare, implement, and comply with written policies and
procedures for pharmacy operations and drug dispensing
and distribution,
2. Review biennially and if necessary revise the policies and
procedures required under subsection (E)(1),
3. Document the review required under subsection (E)(2),
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 62 Supp. 20-1 March 31, 2020
4. Assemble the policies and procedures as a written manual
or by another method approved by the Board or its desig-
nee, and
5. Make the policies and procedures available in the phar-
macy for employee reference and inspection by the Board
or its designee.
Historical Note
Adopted effective April 5, 1996 (Supp. 96-2). Amended
by final rulemaking at 9 A.A.R. 1064, effective May 4,
2003 (Supp. 03-1). Amended by final rulemaking at 10
A.A.R. 3391, effective October 2, 2004 (Supp. 04-3).
Amended by final rulemaking at 12 A.A.R. 3032, effec-
tive October 1, 2006 (Supp. 06-3).
R4-23-672. Limited-service Correctional Pharmacy
A. The limited-service pharmacy permittee shall ensure that the
limited-service correctional pharmacy complies with the stan-
dards for area, personnel, security, sanitation, equipment, drug
distribution and control, administration of drugs, drug source,
quality assurance, investigational drugs, and inspections as set
forth in R4-23-608, R4-23-609(A) through (D) and (F)
through (H), R4-23-610(A), R4-23-611, R4-23-612, R4-23-
653(E), R4-23-658(B) through (E), R4-23-659, and R4-23-
660.
B. The pharmacist-in-charge of a limited-service correctional
pharmacy shall authorize only pharmacists, interns, pharmacy
technicians, pharmacy technician trainees, compliance offi-
cers, drug inspectors, peace officers, and correctional officers
acting in their official capacities, other persons authorized by
law, support personnel, and other designated personnel to be in
the limited-service correctional pharmacy.
C. When no pharmacist will be on duty in the correctional facil-
ity, the pharmacist-in-charge shall arrange, before there is no
pharmacist on duty, for the medical staff and other authorized
personnel of the correctional facility to have access to drugs in
remote drug storage areas or, if a drug is not available in a
remote drug storage area and is required to treat the immediate
needs of a patient, in the limited-service correctional phar-
macy.
1. The pharmacist-in-charge shall, in consultation with the
appropriate committee of the correctional facility,
develop and implement procedures to ensure that remote
drug storage areas:
a. Contain only properly labeled drugs that might rea-
sonably be needed and can be administered safely
during the pharmacist’s absence,
b. Contain drugs packaged only in amounts sufficient
for immediate therapeutic requirements,
c. Are accessible only with a physician’s written order,
d. Provide a written record of each drug withdrawn,
e. Are inventoried at least once each week, and
f. Are audited for compliance with the requirements of
this rule at least once each month.
2. The pharmacist-in-charge shall, in consultation with the
appropriate committee of the correctional facility,
develop and implement procedures to ensure that access
to the limited-service correctional pharmacy when no
pharmacist is on duty conforms to the following require-
ments:
a. Is delegated to only one nurse, who is in a supervi-
sory position;
b. Is communicated in writing to medical staff of the
correctional facility;
c. Is delegated only to a nurse who has received train-
ing from the pharmacist-in-charge in proper meth-
ods of access, removal of drugs, and recordkeeping
procedures; and
d. Is delegated by the supervisory nurse to another
nurse only in an emergency.
3. When a nurse to whom authority to access the limited-
service correctional pharmacy is delegated removes a
drug from the limited-service correctional pharmacy, the
nurse shall:
a. Record the following information on a form:
i. Patient’s name,
ii. Name of the drug and its strength and dosage
form,
iii. Dose prescribed,
iv. Amount of drug removed, and
v. Date and time of removal;
b. Sign the form recording the drug removal;
c. Attach the original or a direct copy of a physician’s
written order for the drug to the form recording the
drug removal; and
d. Place the form recording the drug removal conspicu-
ously in the limited-service correctional pharmacy.
4. Within four hours after a pharmacist in the limited-ser-
vice correctional pharmacy returns to duty following an
absence in which the limited-service correctional phar-
macy was accessed by a nurse to whom authority had
been delegated, the pharmacist shall verify all records of
drug removal according to R4-23-402.
D. When no pharmacist will be on duty in the correctional facil-
ity, the pharmacist-in-charge shall arrange, before there is no
pharmacist on duty, for the medical staff and other authorized
personnel of the correctional facility to have telephone access
to a pharmacist.
E. The limited-service pharmacy permittee shall ensure that the
limited-service correctional pharmacy is not without a phar-
macist on duty for more than 96 consecutive hours.
F. In addition to the requirements of R4-23-671, the limited-ser-
vice pharmacy permittee shall secure the limited-service cor-
rectional pharmacy as follows:
1. Permit no one to be in the limited-service correctional
pharmacy unless a pharmacist is on duty except:
a. As provided in subsection (C)(3) when a pharmacist
is not on duty; or
b. A pharmacy technician or pharmacy technician
trainee may remain to perform duties in R4-23-
1104(A), when a pharmacist is on duty and available
in the correctional facility but temporarily absent
from the pharmacy, provided:
i. All controlled substances are secured in a man-
ner that prohibits access by persons other than a
pharmacist;
ii. Activities performed by a pharmacy technician
or pharmacy technician trainee while the phar-
macist is temporarily absent are verified by the
pharmacist immediately upon returning to the
pharmacy;
iii. Any drug measured, counted, poured, or other-
wise prepared and packaged by a pharmacy
technician or pharmacy technician trainee
while the pharmacist is temporarily absent is
verified by the pharmacist immediately upon
returning to the pharmacy; and
iv. Any drug that has not been verified by a phar-
macist for accuracy is not dispensed, supplied,
or distributed while the pharmacist is temporar-
ily absent from the pharmacy; and
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 63
2. Provide keyed or programmable locks to all areas of the
limited-service correctional pharmacy.
G. The pharmacist-in-charge of a limited-service correctional
pharmacy shall ensure that the written policies and procedures
for pharmacy operations and drug distribution within the cor-
rectional facility include the following:
1. Physicians’ orders, prescription orders, or both;
2. Authorized abbreviations;
3. Formulary system;
4. Clinical services and drug utilization management includ-
ing:
a. Participation in drug selection,
b. Drug utilization reviews,
c. Inventory audits,
d. Patient outcome monitoring,
e. Committee participation,
f. Drug information, and
g. Education of pharmacy and other health profession-
als;
5. Duties and qualifications of professional and support
staff;
6. Products of abuse and contraband medications;
7. Controlled substances;
8. Drug administration;
9. Drug product procurement;
10. Drug compounding, dispensing, and storage;
11. Stop orders;
12. Pass or discharge medications;
13. Investigational drugs and their protocols;
14. Patient profiles;
15. Quality management procedures for:
a. Adverse drug reactions;
b. Drug recalls;
c. Expired and beyond-use-date drugs;
d. Medication or dispensing errors;
e. Drug storage; and
f. Education of professional staff, support staff, and
patients;
16. Recordkeeping;
17. Sanitation;
18. Security;
19. Access to remote drug storage areas by non-pharmacists;
and
20. Access to limited-service correctional pharmacy by non-
pharmacists.
Historical Note
Adopted effective April 5, 1996 (Supp. 96-2). Amended
by final rulemaking at 10 A.A.R. 4453, effective Decem-
ber 4, 2004 (Supp. 04-4).
R4-23-673. Limited-service Mail-order Pharmacy
A. The limited-service pharmacy permittee shall design and con-
struct the limited-service mail-order pharmacy to conform
with the following requirements:
1. A dispensing area devoted to stocking, compounding, and
dispensing prescription medications, which is physically
separate from a non-dispensing area devoted to non-dis-
pensing pharmacy services;
2. A dispensing area of at least 300 square feet if three or
fewer persons work in the dispensing area simultane-
ously;
3. A dispensing area that provides 300 square feet plus 60
square feet for each person in excess of three persons if
more than three persons work in the dispensing area
simultaneously;
4. Space in the dispensing area permits efficient pharmaceu-
tical practice, free movement of personnel, and visual
surveillance by the pharmacist;
5. A non-dispensing area of at least 30 square feet for each
person working simultaneously in the non-dispensing
area; and
6. Space in the non-dispensing area permits free movement
of personnel and visual surveillance by the pharmacist; or
B. The limited-service pharmacy permittee shall design and con-
struct the limited-service mail-order pharmacy to conform
with the following requirements:
1. A contiguous area in which both dispensing and non-dis-
pensing pharmacy services are provided;
2. A contiguous area of at least 300 square feet if three or
fewer persons work in the area simultaneously;
3. A contiguous area that provides 300 square feet plus 60
square feet for each person in excess of three persons if
more than three persons work in the area simultaneously;
and
4. Space in the contiguous area permits efficient pharma-
ceutical practice, free movement of personnel, and visual
surveillance by the pharmacist.
C. The limited-service pharmacy permittee shall ensure that the
limited-service mail-order pharmacy complies with the stan-
dards for area, personnel, security, sanitation, and equipment
set forth in R4-23-608, R4-23-609(B) through (H), R4-23-610
(A) and (C) through (F), R4-23-611, and R4-23-612.
D. The pharmacist-in-charge of a limited-service mail-order phar-
macy shall authorize only pharmacists, interns, pharmacy
technicians, pharmacy technician trainees, compliance offi-
cers, drug inspectors, peace officers acting in their official
capacities, support personnel, other persons authorized by law,
and other designated personnel to be in the limited-service
mail-order pharmacy.
E. The pharmacist-in-charge of a limited-service mail-order phar-
macy shall ensure that prescription medication is delivered to
the patient or locked in the dispensing area when a pharmacist
is not present in the pharmacy.
F. In addition to the delivery requirements of R4-23-402, the lim-
ited-service pharmacy permittee shall, during regular hours of
operation but not less than five days and a minimum 40 hours
per week, provide toll-free telephone service to facilitate com-
munication between patients and a pharmacist who has access
to patient records at the limited-service mail-order pharmacy.
The limited-service pharmacy permittee shall disclose this
toll-free number on a label affixed to each container of drugs
dispensed from the limited-service mail-order pharmacy.
G. The pharmacist-in-charge of a limited-service mail-order phar-
macy shall ensure that the written policies and procedures for
pharmacy operations and drug distribution include the follow-
ing:
1. Prescription orders;
2. Clinical services and drug utilization management for:
a. Drug utilization reviews,
b. Inventory audits,
c. Patient outcome monitoring,
d. Drug information, and
e. Education of pharmacy and other health profession-
als;
3. Duties and qualifications of professional and support
staff;
4. Controlled substances;
5. Drug product procurement;
6. Drug compounding, dispensing, and storage;
7. Patient profiles;
8. Quality management procedures for:
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 64 Supp. 20-1 March 31, 2020
a. Adverse drug reactions,
b. Drug recalls,
c. Expired and beyond-use-date drugs,
d. Medication or dispensing errors, and
e. Education of professional and support staff;
9. Recordkeeping;
10. Sanitation;
11. Security;
12. Drug delivery requirements for:
a. Transportation,
b. Security,
c. Temperature and other environmental controls,
d. Emergency provisions, and
13. Patient education.
Historical Note
Adopted effective April 5, 1996 (Supp. 96-2). Amended
by final rulemaking at 10 A.A.R. 1192, effective May 1,
2004 (Supp. 04-1). Amended by final rulemaking at 10
A.A.R. 4453, effective December 4, 2004 (Supp. 04-4).
R4-23-674. Limited-service Long-term Care Pharmacy
A. A limited-service pharmacy permittee shall ensure that the
limited-service long-term care pharmacy complies with:
1. The general requirements of R4-23-671;
2. The professional practice standards of Article 4 and Arti-
cle 11; and
3. The permits and drug distribution standards of R4-23-606
through R4-23-612, R4-23-670, and this Section.
B. If a limited-service long-term care pharmacy permittee con-
tracts with a long-term care facility as a Provider Pharmacy, as
defined in R4-23-110, the limited-service long-term care phar-
macy permittee shall ensure that the long-term care consultant
pharmacist and the pharmacist-in-charge of the limited-service
long-term care pharmacy comply with R4-23-701, R4-23-
701.01, R4-23-701.02, R4-23-701.03, R4-23-701.04, and this
Section.
C. The limited-service long-term care pharmacy permittee or
pharmacist-in-charge shall ensure that prescription medication
is delivered to the patient’s long-term care facility or locked in
the dispensing area of the pharmacy when a pharmacist is not
present in the pharmacy.
D. The pharmacist-in-charge of a limited-service long-term care
pharmacy shall authorize only those individuals listed in R4-
23-610(B) to be in the limited-service long-term care phar-
macy.
E. In consultation with the long-term care facility’s medical
director and director of nursing, the long-term care consultant
pharmacist and pharmacist-in-charge of the long-term care
facility’s provider pharmacy may develop, if necessary, a med-
ication formulary for the long-term care facility that ensures
the safe and efficient procurement, dispensing, distribution,
administration, and control of drugs in the long-term care
facility.
F. The limited-service long-term care pharmacy permittee or
pharmacist-in-charge shall ensure that the written policies and
procedures required in R4-23-671(E) include the following:
1. Clinical services and drug utilization management for:
a. Drug utilization reviews,
b. Inventory audits,
c. Patient outcome monitoring,
d. Drug information, and
e. Education of pharmacy and other health profession-
als;
2. Controlled substances;
3. Drug compounding, dispensing, and storage;
4. Drug delivery requirements for:
a. Transportation,
b. Security,
c. Temperature and other environmental controls, and
d. Emergency provisions;
5. Drug product procurement;
6. Duties and qualifications of professional and support
staff;
7. Emergency drug supply unit procedures;
8. Formulary, including development, review, modification,
use, and documentation, if applicable;
9. Patient profiles;
10. Patient education;
11. Prescription orders, including:
a. Approved abbreviations,
b. Stop-order procedures, and
c. Leave-of-absence and discharge prescription order
procedures;
12. Quality management procedures for:
a. Adverse drug reactions,
b. Drug recalls,
c. Expired and beyond-use-date drugs,
d. Medication or dispensing errors, and
e. Education of professional and support staff;
13. Recordkeeping;
14. Sanitation; and
15. Security.
Historical Note
New Section made by final rulemaking at 9 A.A.R. 1064,
effective May 4, 2003 (Supp. 03-1). Amended by final
rulemaking at 10 A.A.R. 1192, effective May 1, 2004
(Supp. 04-1). Amended by final rulemaking at 19 A.A.R.
2894, effective November 10, 2013 (Supp. 13-3).
R4-23-675. Limited-service Sterile Pharmaceutical Products
Pharmacy
A. The limited-service pharmacy permittee or the pharmacist-in-
charge shall ensure that the limited-service sterile pharmaceu-
tical products pharmacy complies with the standards for area,
personnel, security, sanitation, equipment, sterile pharmaceuti-
cal products, and limited-service pharmacies established in
R4-23-608, R4-23-609, R4-23-610, R4-23-611, R4-23-612,
R4-23-670, and R4-23-671.
B. The pharmacist-in-charge of a limited-service sterile pharma-
ceutical products pharmacy shall authorize only pharmacists,
interns, compliance officers, peace officers acting in their offi-
cial capacities, pharmacy technicians, pharmacy technician
trainees, support personnel, and other designated personnel to
be in the limited-service sterile pharmaceutical products phar-
macy.
C. The pharmacist-in-charge of a limited-service sterile pharma-
ceutical products pharmacy shall ensure that prescription med-
ication is delivered to the patient or locked in the dispensing
area when a pharmacist is not present in the pharmacy.
D. In addition to the delivery requirements of R4-23-402, the lim-
ited-service pharmacy permittee shall, during regular hours of
operation, but not less than a minimum 40 hours per week,
provide toll-free telephone service to facilitate communication
between patients and a pharmacist who has access to patient
records at the limited-service sterile pharmaceutical products
pharmacy. The limited-service pharmacy permittee shall dis-
close this toll-free number on a label affixed to each container
dispensed from the limited-service sterile pharmaceutical
products pharmacy.
E. The limited-service pharmacy permittee or the pharmacist-in-
charge shall ensure development, implementation, review and
revision in the same manner described in R4-23-671(E) and
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 65
compliance with policies and procedures for pharmacy opera-
tions, including pharmaceutical product compounding, dis-
pensing, and distribution, that comply with the requirements of
R4-23-402, R4-23-410, R4-23-670, and R4-23-671.
F. The non-dispensing roles of the pharmacist may include chart
reviews, audits, drug therapy monitoring, committee participa-
tion, drug information, and in-service training of pharmacy
and other health professionals.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
3391, effective October 2, 2004 (Supp. 04-3). Amended
by final rulemaking at 12 A.A.R. 3032, effective October
1, 2006 (Supp. 06-3). This Section was not amended as
originally stated in the historical note published in Supp.
13-3; therefore the reference to the amendment has been
removed (Supp. 18-2).
R4-23-676. Third-party Logistics Provider Permit
A. A person shall not provide logistics services, as described
under A.R.S. § 32-1941(A), until the Board issues a third-
party logistics provider permit for the facility.
B. A person that wants to provide logistics services shall obtain a
Board-issued third-party logistics provider permit for each
facility.
C. Application. To obtain a third-party logistics provider permit
for a facility, a person shall submit a completed application,
using a form available on the Board’s website, and the fee
specified in R4-23-205.
D. Change of ownership. A third-party logistics provider permit-
tee shall comply with R4-23-601(F).
E. A third-party logistics provider permittee shall renew the per-
mit as specified under R4-23-602(D).
F. The Board shall adhere to the time frames specified under R4-
23-602(C) when processing an initial or renewal application
for a third-party logistics provider permit.
Historical Note
New Section made by final rulemaking at 25 A.A.R.
1015, effective June 1, 2019 (Supp. 19-2).
R4-23-677. Automated Prescription-dispensing Kiosk Permit
A. General provisions.
1. Only a person issued a Board permit under A.R.S. § 32-
1929 to operate a pharmacy in Arizona may apply to the
Board under A.R.S. § 32-1930 for a permit to operate an
automated prescription-dispensing kiosk.
2. A pharmacy permittee described under subsection (A)(1)
shall apply for a separate permit for each automated pre-
scription-dispensing kiosk to be operated.
3. To obtain an automated prescription-dispensing kiosk
permit, a pharmacy permittee shall submit a completed
application, using a form available on the Board’s web-
site, and the fee specified in R4-23-205.
4. A pharmacy permittee to which the Board issues an auto-
mated prescription-dispensing kiosk permit shall desig-
nate a pharmacist in charge of the automated
prescription-dispensing kiosk.
5. A pharmacy permittee to which the Board issues an auto-
mated prescription-dispensing kiosk permit shall not
place the automated prescription-dispensing kiosk in a
gas station or convenience store.
B. Policies and procedures. A pharmacy permittee to which the
Board issues an automated prescription-dispensing kiosk per-
mit shall:
1. Ensure policies and procedures are established for the
appropriate performance and use of the automated pre-
scription-dispensing kiosk. The policies and procedures
shall address:
a. Maintaining a record of each transaction in a manner
that attaches the record to the permit number of the
automated prescription-dispensing kiosk;
b. Controlling access to the automated prescription-
dispensing kiosk;
c. Operating the automated prescription-dispensing
kiosk;
d. Training personnel who use the automated prescrip-
tion-dispensing kiosk;
e. Maintaining patient services when the automated
prescription-dispensing kiosk is not operating or the
prescribed drug or device is not available;
f. Securing the automated prescription-dispensing
kiosk against unauthorized removal of the kiosk or
access to or removal of drugs or devices from the
kiosk;
g. Assuring a patient receives the pharmacy services
necessary for appropriate pharmaceutical care
including consultation with a pharmacist;
h. Maintaining integrity of information in the system
and patient confidentiality;
i. Stocking and restocking the automated prescription-
dispensing kiosk;
j. Ensuring compliance with packaging and labeling
requirements; and
k. Removing drugs and devices from the automated
prescription-dispensing kiosk without dispensing
them and handling wasted or discarded drugs and
devices;
2. Ensure the policies and procedures are implemented and
complied with by all personnel using the automated pre-
scription-dispensing kiosk;
3. Maintain the policies and procedures by:
a. Reviewing the policies and procedures biennially
and making needed revisions, if any;
b. Documenting the review required under subsection
(B)(3)(a);
c. Assembling the policies and procedures as a written
or electronic manual; and
d. Making the policies and procedures available within
the pharmacy permittee to which the Board issued
an automated prescription-dispensing kiosk permit
for reference by pharmacy personnel and inspection
by the Board; and
4. Implement a quality assurance program to monitor com-
pliance with the policies and procedures and all state and
federal law.
C. Change of ownership. An automated prescription-dispensing
kiosk permittee shall comply with R4-23-601(F).
D. An automated prescription-dispensing kiosk permittee shall
renew the permit as specified under R4-23-602(D).
E. The Board shall adhere to the time frames specified under R4-
23-602(C) when processing an initial or renewal application
for an automated prescription-dispensing kiosk permit.
Historical Note
New Section made by final rulemaking at 25 A.A.R.
1012, effective June 1, 2019 (Supp. 19-2).
R4-23-678. Reserved
R4-23-679. Reserved
R4-23-680. Reserved
R4-23-681. General Requirements for Limited-service
Nuclear Pharmacy
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 66 Supp. 20-1 March 31, 2020
A. To be an authorized nuclear pharmacist, a pharmacist shall:
1. Hold a current pharmacist license issued by the Board;
and
2. Be certified as a nuclear pharmacist by:
a. The Board of Pharmaceutical Specialties, or
b. A similar group recognized by the Arizona State
Board of Pharmacy; or
3. Satisfy each of the following requirements:
a. Meet minimal standards of training for status as an
authorized user of radioactive material, as specified
by the Arizona Radiation Regulatory Agency and
the United States Nuclear Regulatory Commission;
b. Submit certification of completion of a Board-
approved nuclear pharmacy training program or
other training program recognized by the Arizona
Radiation Regulatory Agency, with 200 hours of
didactic training in the following areas:
i. Radiation physics and instrumentation,
ii. Radiation protection,
iii. Mathematics pertaining to the use and measure-
ment of radioactivity,
iv. Radiation biology, and
v. Radiopharmaceutical chemistry;
c. Submit evidence of a minimum of 500 hours of clin-
ical/practical nuclear pharmacy training under the
supervision of an authorized nuclear pharmacist in
the following areas:
i. Procuring radioactive materials;
ii. Compounding radiopharmaceuticals;
iii. Performing routine quality control procedures;
iv. Dispensing radiopharmaceuticals;
v. Distributing radiopharmaceuticals;
vi. Implementing basic radiation protection proce-
dures; and
vii. Consulting and educating the nuclear medicine
community, patients, pharmacists, other health
professionals, and the general public; and
d. Submit written certification, signed by a preceptor
who is an authorized nuclear pharmacist, that the
above training was satisfactorily completed.
B. Radiopharmaceuticals are prescription-only drugs that require
specialized techniques in their handling and testing, to obtain
optimum results and minimize hazards.
1. A person shall not sell, barter, or otherwise dispose of, or
be in possession of any radiopharmaceutical except under
the conditions detailed in A.R.S. § 32-1929.
2. A person shall not manufacture, compound, sell, or dis-
pense any radiopharmaceutical unless the person is a
pharmacist or a pharmacy intern acting under the direct
supervision of a pharmacist in accordance with A.R.S. §
32-1961 and these rules, with the exception of the follow-
ing, if the following are licensed by the Arizona Radia-
tion Regulatory Agency to use radiopharmaceuticals in
compliance with A.R.S. § 30-673;
a. A medical practitioner who administers a radiophar-
maceutical to the medical practitioner’s patient as
provided in A.R.S. § 32-1921(A),
b. A hospital nuclear medicine department, and
c. A medical practitioner’s office.
3. The Board shall cooperate with the Arizona Radiation
Regulatory Agency and other interested state and federal
agencies, in the enforcement of these rules for the protec-
tion of the public. This cooperation may include
exchange of licensing and other information, joint inspec-
tions, and other activities where indicated.
C. In addition to compliance with all the applicable federal and
state laws and rules governing drugs, whether radioactive or
not, a limited-service nuclear pharmacy permittee shall com-
ply with all laws and rules of the Arizona Radiation Regula-
tory Agency and the U.S. Nuclear Regulatory Commission,
including emergency and safety provisions.
D. A limited-service nuclear pharmacy permittee shall comply
with the education, experience, and licensing requirements of
the Arizona Radiation Regulatory Agency.
E. A limited-service nuclear pharmacy permittee shall ensure that
radiopharmaceuticals are transferred only to a person or firm
that holds a current Radioactive Materials License issued by
the Arizona Radiation Regulatory Agency.
Historical Note
Adopted effective December 3, 1974 (Supp. 75-1).
Amended subsections (A), (C) and (D) effective Aug. 12,
1988 (Supp. 88-3). Amended effective July 8, 1997
(Supp. 97-3).
R4-23-682. Limited-service Nuclear Pharmacy
A. Before operating a limited-service nuclear pharmacy, a person
shall obtain a permit in compliance with A.R.S. §§ 32-1929,
32-1930, and 32-1931, and R4-23-606.
B. A permit to operate a limited-service nuclear pharmacy shall
be issued only to a person who is or employs an authorized
nuclear pharmacist and holds a current Arizona Radiation
Regulatory Agency Radioactive Materials License. A limited-
service nuclear pharmacy permittee that fails to maintain a
current Arizona Radiation Regulatory Agency Radioactive
Materials License shall be immediately suspended pending
revocation by the Board. A limited-service nuclear pharmacy
permittee shall have copies of Arizona Radiation Regulatory
Agency inspection reports available upon request for Board
inspection.
1. A limited-service nuclear pharmacy permittee shall des-
ignate an authorized nuclear pharmacist as the pharma-
cist-in-charge. The pharmacist-in-charge shall be
responsible to the Board:
a. For the operations of the pharmacy related to the
practice of pharmacy and distribution of drugs and
devices;
b. For communicating Board directives to the manage-
ment, pharmacists, interns, and other personnel of
the pharmacy; and
c. For the pharmacy’s compliance with all federal and
state pharmacy laws and rules.
2. An authorized nuclear pharmacist shall directly supervise
all personnel performing tasks in the preparation and dis-
tribution of radiopharmaceuticals and ancillary drugs.
3. An authorized nuclear pharmacist shall be present when-
ever the limited-service nuclear pharmacy is open for
business.
C. A limited-service nuclear pharmacy permittee shall ensure that
the limited-service nuclear pharmacy complies with the stan-
dards for personnel, area, security, sanitation, and general
requirements in R4-23-608, R4-23-609, R4-23-610, R4-23-
611, and R4-23-671.
1. A limited-service nuclear pharmacy shall contain sepa-
rate areas for:
a. Preparing and dispensing radiopharmaceuticals,
b. Receiving and shipping radiopharmaceuticals,
c. Storing radiopharmaceuticals, and
d. Decaying radioactive waste.
2. The Board may require more than the minimum area in
instances where equipment, inventory, personnel, or other
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 67
factors cause crowding to a degree that interferes with
safe pharmacy practice.
D. The pharmacist-in-charge shall designate in writing, by title
and specific area, the persons who may have access to particu-
lar pharmacy areas.
E. A limited-service nuclear pharmacy permittee shall maintain
records of acquisition, inventory, and disposition of radiophar-
maceuticals, other radioactive substances, and other drugs in
accordance with federal and state statutes and rules.
1. A prescription order, in addition to the requirements in
A.R.S. § 32-1968(C) and R4-23-407(A), shall contain:
a. The date and time of calibration of the radiopharma-
ceutical,
b. The name of the procedure for which the radiophar-
maceutical is prescribed, and
c. The words “Physician’s Use Only” instead of the
name of the patient if the radiopharmaceutical is
nontherapeutic or for a nonblood product.
2. The lead container used to store and transport a radio-
pharmaceutical shall have a label that, in addition to the
requirements in A.R.S. § 32-1968(D), includes:
a. The date and time of calibration of the radiopharma-
ceutical,
b. The name of the radiopharmaceutical,
c. The molybdenum 99 content to USP limits,
d. The name of the procedure for which the radiophar-
maceutical is prescribed,
e. The words “Physician’s Use Only” instead of the
name of the patient if the radiopharmaceutical is
nontherapeutic or for a nonblood product,
f. The words “Caution: Radioactive Material,” and
g. The standard radiation symbol.
3. The radiopharmaceutical container shall have a label that
includes:
a. The date and time of calibration of the radiopharma-
ceutical;
b. The name of the patient, recorded before dispensing,
if the radiopharmaceutical is therapeutic or for a
blood product;
c. The words “Physician’s Use Only” instead of the
name of the patient if the radiopharmaceutical is
nontherapeutic or for a nonblood product;
d. The name of the radiopharmaceutical;
e. The dose of radiopharmaceutical;
f. The serial number;
g. The words “Caution: Radioactive Material”; and
h. The standard radiation symbol.
F. The following minimum requirements are in addition to the
requirements of the Arizona Radiation Regulatory Agency, the
applicable U.S. Nuclear Regulatory Commission regulations,
and the applicable regulations of the federal Food and Drug
Administration. A limited-service nuclear pharmacy permittee
shall provide:
1. In addition to the minimum pharmacy area requirements
in R4-23-609:
a. An area for the storing, compounding, and dispens-
ing of radiopharmaceuticals completely separate
from pharmacy areas for nonradioactive drugs;
b. A minimum of 80 sq. ft. for a hot lab and storage
area; and
c. A minimum of 300 sq. ft. of compounding and dis-
pensing area;
2. The following equipment:
a. Fume hood, approved by the Arizona Radiation
Regulatory Agency;
b. Laminar flow hood;
c. Dose calibrator;
d. Refrigerator;
e. Prescription balance, Class A, and weights or an
electronic balance of equal or greater accuracy;
f. Well scintillation counter;
g. Incubator oven;
h. Microscope;
i. An assortment of labels, including prescription
labels and cautionary and warning labels;
j. Glassware necessary for compounding and dispens-
ing radiopharmaceuticals as required by the Arizona
Radiation Regulatory Agency;
k. Other equipment necessary for radiopharmaceutical
quality control for products compounded or dis-
pensed as required by the Arizona Radiation Regula-
tory Agency;
l. Current antidote and drug interaction information;
and
m. Regional poison control phone number prominently
displayed in the pharmacy area;
3. Supplies necessary for compounding and dispensing
radiopharmaceuticals as required by the Arizona Radia-
tion Regulatory Agency;
4. A professional reference library consisting of a minimum
of one current reference or text addressing each of the fol-
lowing subject areas:
a. Therapeutics,
b. Nuclear pharmacy practice, and
c. Imaging;
5. Current editions and supplements of:
a. A.R.S. §§ 30-651 through 30-696 pertaining to the
Arizona Radiation Regulatory Agency,
b. Rules of the Arizona Radiation Regulatory Agency,
c. Regulations of the federal Food and Drug Adminis-
tration pertaining to radioactive drugs,
d. Arizona Pharmacy Act and rules,
e. Arizona Uniform Controlled Substances Act, and
f. Radiological Health Handbook.
G. The pharmacist-in-charge of a limited-service nuclear phar-
macy shall prepare, implement, review, and revise in the same
manner described in R4-23-671(E) and comply with written
policies and procedures for pharmacy operations and drug dis-
tribution.
H. The written policies and procedures of a limited-service
nuclear pharmacy shall include the following:
1. Prescription orders;
2. Clinical services and drug utilization management includ-
ing:
a. Drug utilization reviews,
b. Inventory audits,
c. Patient outcome monitoring,
d. Drug information, and
e. Education of pharmacy and other health profession-
als;
3. Duties and qualifications of professional and support
staff;
4. Radioactive material handling, storage, and disposal;
5. Drug product procurement;
6. Drug compounding, dispensing, and storage;
7. Investigational drugs and their protocols;
8. Patient profiles;
9. Quality management procedures for:
a. Adverse drug reaction reports;
b. Drug recall;
c. Expired and beyond-use-date drugs;
d. Medication or dispensing errors;
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 68 Supp. 20-1 March 31, 2020
e. Radiopharmaceutical quality assurance;
f. Radiological health and safety;
g. Drug storage and disposition; and
h. Education of professional staff, support staff, and
patients;
10. Recordkeeping;
11. Sanitation;
12. Security;
13. Drug delivery requirements for:
a. Transportation,
b. Security,
c. Radiological health and safety procedures,
d. Temperature and other environmental controls, and
e. Emergency provisions; and
14. Patient education.
Historical note
Adopted effective July 8, 1997 (Supp. 97-3). Amended
by final rulemaking at 12 A.A.R. 3032, effective October
1, 2006 (Supp. 06-3).
R4-23-683. Reserved
R4-23-684. Reserved
R4-23-685. Reserved
R4-23-686. Reserved
R4-23-687. Reserved
R4-23-688. Reserved
R4-23-689. Reserved
R4-23-690. Reserved
R4-23-691. Repealed
Historical Note
Adopted effective Dec. 3, 1974 (Supp. 75-1). Amended
effective Aug. 12, 1988 (Supp. 88-3). Amended effective
November 1, 1993 (Supp. 93-4). Repealed effective July
8, 1997 (Supp. 97-3).
R4-23-692. Compressed Medical Gas (CMG) Distributor-
Resident or Nonresident
A. Permit.
1. A person shall not manufacture, process, transfill, pack-
age, or label a compressed medical gas in Arizona, or
manufacture, process, transfill, package, or label a com-
pressed medical gas outside Arizona and ship into Ari-
zona without a current Board-issued resident or
nonresident compressed medical gas distributor permit.
2. Before operating as a compressed medical gas distributor,
a person shall register with the FDA as a medical gas
manufacturer and comply with the drug listing require-
ments of the federal act.
B. Application. To obtain a resident or nonresident CMG distrib-
utor permit, a person shall submit to the Board a completed
application form and the fee specified in R4-23-205.
1. A resident CMG distributor permit applicant shall include
documentation of compliance with local zoning laws, if
required by the Board.
2. A nonresident CMG distributor permit applicant that
resides in a jurisdiction that issues an equivalent license
or permit shall include a copy of the equivalent license or
permit.
C. Notification. A resident or nonresident CMG distributor per-
mittee shall submit using the permittee’s online profile or pro-
vide written notice by mail, fax, or e-mail to the Board office
within 10 days of changes involving the telephone or fax num-
ber, e-mail or mailing address, or business name.
D. Change of ownership. A resident or nonresident CMG distrib-
utor permittee shall comply with R4-23-601(F).
E. Relocation.
1. No fewer than 30 days before a resident CMG distributor
permittee relocates, the permittee shall electronically or
manually submit a completed application for relocation
using a form furnished by the Board, and the documenta-
tion required in subsection (B). A fee is not required with
an application for relocation.
2. A nonresident CMG distributor permittee shall provide
written notice by mail, fax, or e-mail to the Board office
no fewer than 10 days before relocating.
F. A resident or nonresident CMG distributor permittee is autho-
rized to sell or distribute a compressed medical gas under a
compressed medical gas order only to durable medical equip-
ment and compressed medical gas suppliers and other entities
that are registered, licensed, or permitted to use, administer, or
distribute compressed medical gases.
G. Facility. A resident or nonresident CMG distributor permittee
shall ensure the facility is clean, uncluttered, sanitary, tem-
perature controlled, and secure from unauthorized access.
H. Current Good Manufacturing Practice: A resident or nonresi-
dent CMG distributor permittee is required under federal law
to follow the good manufacturing practice requirements of 21
CFR parts 210 and 211.
I. Records: A resident or nonresident CMG distributor permittee
shall:
1. Establish and implement written procedures for maintain-
ing records pertaining to production, transfilling, process
control, labeling, packaging, quality control, distribution,
returns, recalls, training of personnel, complaints, and
any information required by federal or state law.
2. Retain the records required by Section R4-23-601, this
Section, and 21 CFR parts 210 and 211 for not fewer than
three years or one year after the expiration date of the
compressed medical gas, whichever is longer.
3. Make the records required by Section R4-23-601, this
Section, and 21 CFR parts 210 and 211 available for
inspection by the Board or its compliance officer, or if
stored in a centralized recordkeeping system apart from
the inspection location and not electronically retrievable,
provide the records within four working days of a request
by the Board or its compliance officer.
J. Inspection.
1. A resident CMG distributor permittee shall make the
CMG distributor’s facility available for inspection by the
Board or its compliance officers under A.R.S. § 32-1904.
2. Within 10 days from the date of a request by the Board or
its staff, a nonresident CMG distributor permittee shall
provide a copy of the most recent inspection report com-
pleted by the permittee’s resident licensing authority or
the FDA or a copy of the most recent inspection report
completed by a third-party auditor approved by the per-
mittee’s resident licensing authority or the Board or its
designee. The Board may inspect, or may employ a third-
party auditor to inspect, a nonresident permittee as speci-
fied in A.R.S. § 32-1904.
K. Permit renewal. To renew a CMG distributor permit, the per-
mittee shall comply with R4-23-602(D).
L. Nothing in this Section shall be construed to prohibit the emer-
gency administration of oxygen by licensed health-care per-
sonnel, emergency medical technicians, first responders, fire
fighters, law enforcement officers, and other emergency per-
sonnel trained in the proper use of emergency oxygen.
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 69
Historical Note
Adopted effective January 12, 1998 (Supp. 98-1).
Amended by final rulemaking at 19 A.A.R. 97, effective
March 10, 2013 (Supp. 13-1). Amended by final
rulemaking at 20 A.A.R. 1364, effective August 2, 2014
(Supp. 14-2). Amended by final rulemaking at 25 A.A.R.
1015, effective June 1, 2019 (Supp. 19-2).
R4-23-693. Durable Medical Equipment (DME) and Com-
pressed Medical Gas (CMG) Supplier-Resident or Nonresident
A. Permit. A person shall not sell, lease, or supply durable medi-
cal equipment or a compressed medical gas to a patient or con-
sumer in Arizona for use in a home or residence without a
current Board-issued resident or nonresident durable medical
equipment and compressed medical gas supplier permit.
1. The permit requirements of this Section do not apply to
the following unless there is a separate business entity
engaged in the business of providing durable medical
equipment or a compressed medical gas to a patient or
consumer for use in a home or residence:
a. A medical practitioner licensed under A.R.S. Title
32;
b. A hospital, long-term care facility, hospice, or other
health-care facility using durable medical equipment
or a compressed medical gas in the normal course of
treating a patient; and
c. A pharmacy.
2. Nothing in this Section shall be construed to prohibit a
person with a current Board-issued nonprescription drug
permit from the retail sale of nonprescription drugs or
devices.
B. Application. To obtain a resident or nonresident DME and
CMG supplier permit, a person shall submit a completed
application form and fee specified in R4-23-205.
1. A resident DME and CMG supplier permit applicant shall
include documentation of compliance with local zoning
laws, if required by the Board.
2. A nonresident DME and CMG supplier permit applicant
that resides in a jurisdiction that issues an equivalent
license or permit shall include a copy of the equivalent
license or permit.
C. Notification. A resident or nonresident DME and CMG sup-
plier permittee shall submit using the permittee’s online profile
or provide written notice by mail, fax, or e-mail to the Board
office within 10 days of changes involving the telephone or
fax number, email or mailing address, or business name.
D. Change of ownership. A resident or nonresident DME and
CMG supplier permittee shall comply with R4-23-601(F).
E. Relocation.
1. No fewer than 30 days before a resident DME and CMG
supplier permittee relocates, the permittee shall submit a
completed application for relocation electronically or
manually on a form furnished by the Board, and the docu-
mentation required in subsection (B). A fee is not
required with an application for relocation.
2. A nonresident DME and CMG supplier permittee shall
provide written notice by mail, fax, or e-mail to the Board
office no fewer than 10 days before relocating.
F. Orders. A resident or nonresident DME and CMG supplier
shall sell, lease, or provide:
1. Durable medical equipment that is a prescription-only
device, as defined in A.R.S. § 32-1901, only under a pre-
scription or medication order from a medical practitioner;
and
2. A compressed medical gas only under a compressed med-
ical gas order from a medical practitioner.
G. Restriction. A DME and CMG supplier permit authorizes the
permittee to procure, possess, and provide a prescription-only
device or compressed medical gas to a patient or consumer as
specified in subsection (F). A DME and CMG supplier permit
does not authorize the permittee to procure, possess, or pro-
vide narcotics or other controlled substances, prescription-
only drugs other than compressed medical gases, precursor
chemicals, or regulated chemicals.
H. Facility. A resident or nonresident DME and CMG supplier
permittee shall ensure the facility is clean, uncluttered, sani-
tary, temperature controlled, and secure from unauthorized
access. A permittee shall maintain separate and identified stor-
age areas in the facility and in delivery vehicles for clean,
dirty, contaminated, or damaged durable medical equipment or
compressed medical gases.
I. A resident or nonresident DME and CMG supplier permittee
shall not manufacture, process, transfill, package, or label a
compressed medical gas, except as stated in subsection (K).
J. Records. A resident or nonresident DME and CMG supplier
permittee shall establish and implement written procedures for
maintaining records about acquisition, distribution, returns,
recalls, training of personnel, maintenance, cleaning, and com-
plaints.
K. A permittee shall:
1. Ensure a prescription order, medication order, or com-
pressed medical gas order is obtained as specified in sub-
section (F);
2. Ensure each compressed medical gas container supplied
by the permittee contains a label bearing the name and
address of the permittee;
3. Ensure all appropriate warning labels are present on the
durable medical equipment or compressed medical gas;
4. Retain the records required by Section R4-23-601 and
this Section for not fewer than three years, or if supplying
a compressed medical gas, one year after the expiration
date of the compressed medical gas, whichever is longer;
and
5. Make the records required by Section R4-23-601 and this
Section available for inspection by the Board or its com-
pliance officer, or if stored in a centralized recordkeeping
system apart from the inspection location and not elec-
tronically retrievable for inspection, provide the records
within four working days of a request by the Board or its
staff.
L. Inspection.
1. A resident DME and CMG supplier permittee shall make
the DME and CMG supplier’s facility available for
inspection by the Board or its compliance officers under
A.R.S. § 32-1904.
2. Within 10 days from the date of a request by the Board or
its staff, a nonresident DME and CMG supplier permittee
shall provide a copy of the most recent inspection report
completed by the permittee’s resident licensing authority,
or a copy of the most recent inspection report completed
by a third-party auditor approved by the permittee’s resi-
dent licensing authority or the Board or its designee. The
Board may inspect, or may employ a third-party auditor
to inspect, a nonresident permittee as specified in A.R.S.
§ 32-1904.
M. Permit renewal. To renew a resident or nonresident DME and
CMG supplier permit, the permittee shall comply with in R4-
23-602(D).
N. Nothing in this Section shall be construed to prohibit the emer-
gency administration of oxygen by licensed health-care per-
sonnel, emergency medical technicians, first responders, fire
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 70 Supp. 20-1 March 31, 2020
fighters, law enforcement officers, and other emergency per-
sonnel trained in the proper use of emergency oxygen.
Historical Note
Adopted effective January 12, 1998 (Supp. 98-1).
Amended by final rulemaking at 20 A.A.R. 1364, effec-
tive August 2, 2014 (Supp. 14-2). Amended by final
rulemaking at 25 A.A.R. 1015, effective June 1, 2019
(Supp. 19-2).
ARTICLE 7. NON-PHARMACY LICENSED OUTLETS –
GENERAL PROVISIONS
R4-23-701. Long-term Care Facilities Pharmacy Services:
Consultant Pharmacist
A. The long-term care consultant pharmacist as defined in R4-23-
110 shall:
1. Possess a valid Arizona pharmacist license issued by the
Board;
2. Ensure the provision of pharmaceutical patient care ser-
vices as defined in R4-23-110;
3. Review the distribution and storage of drugs and devices
and assist the facility in establishing policies and proce-
dures for the distribution and storage of drugs and
devices;
4. Provide resident evaluation programs that relate to moni-
toring the therapeutic response and utilization of all drugs
and devices prescribed or administered to residents, using
as guidelines the most current indicators established by
the Centers for Medicare and Medicaid Services, United
States Department of Health and Human Services as
required in 42 CFR 483.60 (revised October 1, 2010,
incorporated by reference and on file with the Board.
This incorporated material contains no future editions or
amendments.).
5. Serve as a resource for pharmacy-related education ser-
vices within the facility;
6. Participate in quality management of resident care in the
facility; and
7. Communicate with the provider pharmacy regarding
areas of mutual concern and resolution.
B. A long-term care consultant pharmacist shall ensure that:
1. When a provider pharmacy is not open for business,
arrangements are made in advance by the long-term care
consultant pharmacist, in cooperation with the pharma-
cist-in-charge of the provider pharmacy and the director
of nursing and medical staff of the long-term care facility,
for providing emergency drugs for the licensed nursing
staff to administer to the residents of the facility using an
emergency drug supply unit located at the facility;
2. The label and packaging of prescription-only and nonpre-
scription drugs intended for use within a long-term care
facility complies with state and federal law; and
3. The long-term care facility:
a. Stores controlled substances listed in A.R.S. § 36-
2513 in a separately locked and permanently affixed
compartment, unless the facility uses a single-unit
package medication distribution system; and
b. Maintains accurate records of controlled substance
administration or ultimate disposition.
C. The long-term care consultant pharmacist shall:
1. Ensure availability of records and reports designed to
provide the data necessary to evaluate the drug use of
each long-term care facility resident that include the fol-
lowing:
a. Provider pharmacy patient profiles and long-term
care facility medication administration records;
b. Reports of suspected adverse drug reactions;
c. Inspection reports of drug storage areas with empha-
sis on detecting outdated drugs; and
d. Accountability reports, that include:
i. Date and time of administration,
ii. Name of the person who administered the drug,
iii. Documentation and verification of any wasted
or partial doses,
iv. Exception reports for refused doses, and
v. All drug destruction forms; and
2. Identify and report drug irregularities and dispensing
errors to the prescriber, the director of nursing of the
facility, and the provider pharmacy.
D. A long-term care consultant pharmacist or pharmacist-in-
charge of a provider pharmacy shall ensure that:
1. Discontinued or outdated drugs, including controlled sub-
stances, are destroyed or disposed of in a timely manner
using methods consistent with federal, state, and local
requirements and subject to review by the Board or its
staff; and
2. Drug containers with illegible or missing labels are:
a. Identified; and
b. Replaced or relabeled by a pharmacist employed by
the pharmacy that dispensed the prescription medi-
cation.
Historical Note
Former Rules 6.8110, 6.8120, 6.8130, 6.8140, 6.8150,
6.8160, and 6.8170; Amended effective Aug. 10, 1978
(Supp. 78-4). Section repealed, new Section adopted
effective December 18, 1992 (Supp. 92-4). Amended by
final rulemaking at 9 A.A.R. 1064, effective May 4, 2003
(Supp. 03-1). Amended by final rulemaking at 12 A.A.R.
3032, effective October 1, 2006 (Supp. 06-3). Amended
by final rulemaking at 19 A.A.R. 2894, effective Novem-
ber 10, 2013 (Supp. 13-3).
R4-23-701.01. Long-term Care Facilities Pharmacy Services:
Provider Pharmacy
The limited-service pharmacy permittee or pharmacist-in-charge of
a provider pharmacy shall ensure that:
1. A prescription medication is provided only by a valid pre-
scription order for an individual long-term care facility
resident, properly labeled for that resident, as specified in
this subsection. Nothing in this Section shall prevent a
provider pharmacy from supplying nonprescription drugs
in a manufacturer’s unopened container or emergency
drugs using an emergency drug supply unit as specified in
R4-23-701.02;
2. A prescription medication label for a long-term care facil-
ity resident complies with A.R.S. §§ 32-1968 and 36-
2525 and contains:
a. The drug name, strength, dosage form, and quantity;
and
b. The beyond-use-date;
3. Only a pharmacist employed by the pharmacy that dis-
pensed the prescription medication may, through the
exercise of professional judgment, relabel or alter a pre-
scription medication label that is illegible or missing;
4. The provider pharmacy develops and implements drug
recall policies and procedures that protect the health and
safety of facility residents. The drug recall procedures
shall include immediate discontinuation of any patient
level recalled drug and notification of the prescriber and
director of nursing of the facility; and
5. Drugs previously dispensed to a resident of the long-term
care facility by another pharmacy, and drugs previously
dispensed by the provider pharmacy, are not repackaged.
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 71
Historical Note
Adopted effective December 18, 1992 (Supp. 92-4).
Amended by final rulemaking at 9 A.A.R. 1064, effective
May 4, 2003 (Supp. 03-1). Amended by final rulemaking
at 19 A.A.R. 2894, effective November 10, 2013 (Supp.
13-3).
R4-23-701.02. Long-term Care Facilities Pharmacy Services:
Emergency Drugs
A. The limited-service pharmacy permittee or pharmacist-in-
charge of a provider pharmacy shall ensure that:
1. An emergency drug supply unit is available within the
long-term care facility,
2. Drugs contained in an emergency drug supply unit
remain the property of the provider pharmacy, and
3. Controlled substance drugs contained in an emergency
drug supply unit are included in all inventories required
under A.R.S. § 36-2523(B) and R4-23-1003(A).
B. An emergency drug supply unit shall meet the following crite-
ria:
1. The drugs are necessary to meet the immediate and emer-
gency therapeutic needs of long-term care facility resi-
dents as determined by the provider pharmacy’s
pharmacist-in-charge in consultation with the long-term
care facility’s medical director and nursing director;
2. The purpose of the emergency drug supply unit in a long-
term care facility is not to relieve a provider pharmacy of
the responsibility for timely provision of the resident’s
routine drug needs, but to ensure that an emergency drug
supply unit is available for facility residents in need of
immediate and emergency therapeutic drugs; and
3. The drugs are provided in a manufacturer’s unit of use
package or are prepackaged and labeled to include the
drug name, strength, dosage form, manufacturer, lot num-
ber, and expiration date and provider pharmacy’s name,
address, telephone number, and pharmacist’s initials.
C. The limited-service pharmacy permittee or pharmacist-in-
charge of a provider pharmacy shall ensure that an emergency
drug supply unit:
1. Is stored in an area that:
a. Is temperature controlled; and
b. Prevents unauthorized access;
2. Contains on the exterior of the emergency drug supply
unit a label to indicate that the contents are for emergency
use only;
3. Contains on the exterior of the emergency drug supply
unit a complete list of the contents of the unit by drug
name, strength, dosage form, and quantity and the pro-
vider pharmacy’s name, address, and telephone number;
4. Contains on the exterior of the emergency drug supply
unit a label that indicates the date of the earliest drug
expiration date;
5. Contains on the exterior of the emergency drug supply
unit a label that indicates the date of and pharmacist
responsible for the last inspection of the emergency drug
supply unit; and
6. Is secured with a tamper-evident seal, or is locked and
sealed in a manner that obviously reveals when the unit
has been opened or tampered with.
D. The limited-service pharmacy permittee or pharmacist-in-
charge of a provider pharmacy shall:
1. Prepare, implement, review, and revise in the same man-
ner described in R4-23-671(E) and comply with written
policies and procedures for the storage and use of an
emergency drug supply unit in a long-term care facility;
2. Make the policies and procedures available in the pro-
vider pharmacy and long-term care facility for employee
reference and inspection by the Board or its staff;
3. Ensure that the written policies and procedures include
the following:
a. Drug removal procedures that require:
i. The long-term care facility’s personnel receive
a valid prescription order for each drug
removed from the emergency drug supply unit,
ii. The long-term care facility’s personnel notify
the provider pharmacy when a drug is removed
from the emergency drug supply unit,
b. Outdated drug replacement procedures, and
c. Security and inspection procedures;
4. Exchange or restock the emergency drug supply unit
weekly, or more often as necessary, to ensure the avail-
ability of an adequate supply of emergency drugs within
the long-term care facility. Restocking of the emergency
drug supply unit at the facility shall be completed by an
Arizona licensed pharmacist employed by the provider
pharmacy, or by an Arizona licensed intern, graduate
intern, technician or technician trainee under the direct
onsite supervision of an Arizona licensed pharmacist; and
5. Educate pharmacy and long-term care facility personnel
in the storage and use of an emergency drug supply unit.
E. In addition to the requirements of subsections (A) through (D),
an automated emergency drug supply unit may be used pro-
vided:
1. The pharmacy permittee or pharmacist-in-charge of the
provider pharmacy notifies the Board or its staff in writ-
ing of the intent to use an automated emergency drug sup-
ply unit, including the name and type of unit;
2. The provider pharmacy is notified electronically when
the automated emergency drug supply unit has been
accessed;
3. All events involving the access of the automated emer-
gency drug supply unit are recorded electronically and
maintained for not less than two years;
4. The provider pharmacy is capable of producing a report
of all transactions of the automated emergency drug sup-
ply unit including a single drug usage report as required
in R4-23-408(B)(5) on inspection by the Board or its
staff;
5. The provider pharmacy develops written policies and
procedures for:
a. Accessing the automated emergency drug supply
unit in the event of a system malfunction or down-
time,
b. Authorizing and modifying user access,
c. An ongoing quality assurance program that includes:
i. Training in the use of the automated emergency
drug supply unit for all authorized users,
ii. Maintenance and calibration of the automated
emergency drug supply unit as recommended
by the device manufacturer; and
6. Documentation of the requirements of subsection
(E)(5)(c)(ii) is maintained for inspection by the Board or
its staff for not less than two years.
F. The Board may prohibit a pharmacy permittee or pharmacist-
in-charge of a provider pharmacy from using an automated
emergency drug supply unit if the pharmacy permittee or phar-
macy permittee’s employees do not comply with the require-
ments of subsections (A) through (E).
Historical Note
Adopted effective December 18, 1992 (Supp. 92-4).
Amended by final rulemaking at 9 A.A.R. 1064, effective
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 72 Supp. 20-1 March 31, 2020
May 4, 2003 (Supp. 03-1). Amended by final rulemaking
at 12 A.A.R. 3032, effective October 1, 2006
(Supp. 06-3). Amended by final rulemaking at 19 A.A.R.
2894, effective November 10, 2013 (Supp. 13-3).
R4-23-701.03. Long-term Care Facilities Pharmacy Services:
Emergency Drug Prescription Order
The limited-service pharmacy permittee or pharmacist-in-charge of
a provider pharmacy shall ensure that every emergency drug pre-
scription order is evaluated according to the requirements of R4-23-
402(A) by a pharmacist within 72 hours of the first dose of drug
administered by long-term care facility personnel under the emer-
gency drug prescription order.
Historical Note
Adopted effective December 18, 1992 (Supp. 92-4).
Amended by final rulemaking at 9 A.A.R. 1064, effective
May 4, 2003 (Supp. 03-1).
R4-23-701.04. Long-term Care Facilities Pharmacy Services:
Automated Dispensing Systems
A. Before using an automated dispensing system as defined in
R4-23-110, a pharmacy permittee or pharmacist-in-charge of a
provider pharmacy shall:
1. Notify the Board or its staff in writing of the intent to use
an automated dispensing system, including the name and
type of system;
2. Obtain a separate controlled substances registration at the
location of each long-term care facility at which an auto-
mated dispensing system containing controlled sub-
stances will be located as required by federal law; and
3. Maintain copies of the registrations required under sub-
section (A)(2) at the provider pharmacy for inspection by
the Board or its staff.
B. A pharmacy permittee or pharmacist-in-charge of a provider
pharmacy shall ensure:
1. Drugs contained in an automated dispensing system
remain the property of the provider pharmacy,
2. Controlled substance drugs contained in an automated
dispensing system are included in all inventories required
under A.R.S. § 36-2523(B) and R4-23-1003(A),
3. Schedule II drugs are not stocked in an automated dis-
pensing system, and
4. A separate emergency drug supply unit is available in the
long-term care facility to meet the requirements of R4-
23-701.02.
C. A pharmacy permittee or pharmacist-in-charge of a provider
pharmacy shall:
1. Ensure that policies and procedures as required in subsec-
tion (D) for the use of an automated dispensing system in
a long-term care facility are prepared, implemented, and
complied with;
2. Review biennially and, if necessary, revise the policies
and procedures required under subsection (D);
3. Document the review required under subsection (C)(2);
4. Assemble the policies and procedures as a written or elec-
tronic manual; and
5. Make the policies and procedures available for employee
reference and inspection by the Board or its staff within
the pharmacy and at any location outside of the pharmacy
where the automated dispensing system is used.
D. A pharmacy permittee or pharmacist-in-charge of a provider
pharmacy shall ensure the written policies and procedures
include:
1. Drug removal procedures that include the following:
a. A drug is provided only by a valid prescription order
for an individual long-term care facility resident;
b. A drug is dispensed from an automated dispensing
system only after a pharmacist has:
i. Reviewed and verified the resident’s prescrip-
tion order as required by R4-23-402(A), and
ii. Electronically authorized the access for that
drug for that particular resident, and
c. The automated dispensing system labels each indi-
vidual drug packet with a resident specific label that
complies with R4-23-701.01(2) and contains the res-
ident’s room number or facility identification num-
ber; and
2. Security procedures that include the following:
a. The pharmacy permittee or pharmacist-in-charge of
the provider pharmacy is responsible for authorizing
user access, including adding and removing users
and modifying user access;
b. Each authorized user is a licensee of the Board or
authorized licensed personnel of the long-term care
facility; and
c. The automated dispensing system is secured at the
long-term care facility by electronic or mechanical
means or a combination thereof designed to prevent
unauthorized access;
3. Drug stocking procedures that include the following:
a. Automated dispensing systems that use non-remov-
able containers that do not allow prepackaging of the
container as set out in subsection (D)(3)(b):
i. Are stocked at the long-term care facility by an
Arizona licensed pharmacist employed by the
provider pharmacy, or by an Arizona licensed
intern, graduate intern, technician or technician
trainee under the direct onsite supervision of an
Arizona licensed pharmacist; and
ii. Utilize bar code or other technologies to ensure
the correct drug is placed in the correct canister
or container; and
b. Automated dispensing systems that use removable
containers may be stocked at the long-term care
facility by an authorized user provided:
i. The prepackaging of the container occurs at the
provider pharmacy;
ii. A pharmacist verifies the container has been
properly filled and labeled, and the container is
secured with a tamper-evident seal;
iii. The individual containers are transported to the
long-term care facility in a secure, tamper-evi-
dent shipping container; and
iv. The automated dispensing system uses micro-
chip, bar-coding, or other technologies to
ensure the containers are accurately loaded in
the automated dispensing system; and
4. Recordkeeping and report procedures that include the fol-
lowing:
a. All events involving the access of the automated dis-
pensing system are recorded electronically and
maintained for not less than two years;
b. The provider pharmacy is capable of producing a
report of all transactions of the automated dispens-
ing system including:
i. A single drug usage report that complies with
R4-23-408(B)(5); and
ii. An authorized user history including date and
time of access and type of transaction; and
c. The provider pharmacy has procedures to safeguard
the storage, packaging, and distribution of drugs by
monitoring:
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 73
i. Current inventory;
ii. Expiration dates;
iii. Controlled substance dispensing;
iv. Re-dispense requests; and
v. Wastage.
E. A pharmacy permittee or pharmacist-in-charge of a provider
pharmacy shall:
1. Ensure that an electronic log is kept for each container fill
that includes:
a. An identification of the container by drug name and
strength, and container number;
b. The drug’s manufacturer or National Drug Code
(NDC) number;
c. The expiration date and lot number from the manu-
facturer’s stock bottle that is used to fill the con-
tainer. If multiple lot numbers of the same drug are
added to a container, each lot number and expiration
date shall be documented;
d. The date the container is filled;
e. Documentation of the identity of the licensee who
placed the drug into the container; and
f. If the licensee who filled the container is not a phar-
macist, documentation of the identity of the pharma-
cist who supervised the non-pharmacist licensee;
and
2. Maintain the electronic log for inspection by the Board or
its staff for not less than two years.
F. A pharmacy permittee or pharmacist-in-charge of a provider
pharmacy shall:
1. Implement an ongoing quality assurance program that
monitors performance of the automated dispensing sys-
tem and compliance with the established policies and pro-
cedures that includes:
a. Training in the use of the automated dispensing sys-
tem for all authorized users,
b. Maintenance and calibration of the automated dis-
pensing system as recommended by the device man-
ufacturer,
c. Routine accuracy validation testing no less than
every three months, and
d. Downtime and malfunction procedures to ensure the
timely provision of medication to the long-term care
facility resident, and
2. Maintain documentation of the requirements of subsec-
tions (F)(1)(b) and (F)(1)(c) for inspection by the Board
or its staff for not less than two years.
G. The Board may prohibit a pharmacy permittee or pharmacist-
in-charge from using an automated dispensing system in a
long-term care facility if the pharmacy permittee or the phar-
macy permittee’s employees do not comply with the require-
ments of subsections (A) through (F).
Historical Note
New Section made by final rulemaking at 19 A.A.R.
2894, effective November 10, 2013 (Supp. 13-3).
R4-23-702. Hospice Inpatient Facilities
A. If a pharmacy permittee contracts to provide pharmacy ser-
vices to the patients of a hospice inpatient facility as defined in
R4-23-110, the pharmacy permittee shall ensure that:
1. A prescription medication is provided only by a valid pre-
scription order for an individual hospice inpatient facility
patient, properly labeled for that patient, as specified in
this subsection. Nothing in this section shall prevent a
provider pharmacy from supplying non-prescription
drugs in a manufacturer’s unopened container;
2. A prescription medication label for a hospice inpatient
facility patient complies with A.R.S. §§ 32-1968 and 36-
2525 and contains:
a. The drug name, strength, dosage form, and quantity;
and
b. The beyond-use date; and
3. If the label on the hospice inpatient facility patient’s drug
container becomes damaged or soiled, a pharmacist
employed by the pharmacy that dispensed the drug con-
tainer, through the exercise of professional judgment,
may relabel the drug container. Only a pharmacist is per-
mitted to label a drug container or alter the label of a drug
container.
B. A pharmacist may help hospice inpatient facility personnel
develop written policies and procedures for the procurement,
administration, storage, control, recordkeeping, and disposal
of drugs in the facility.
C. The provider pharmacy may contract with the hospice inpa-
tient facility to provide pharmacist services at the facility that
include evaluation of the patient’s response to medication ther-
apy, identification of potential adverse drug reactions, and rec-
ommended appropriate corrective action.
D. A provider pharmacy that places an emergency drug supply
unit at a hospice inpatient facility shall comply with the
requirements of R4-23-701.02.
E. A pharmacy shall not place an automated dispensing system as
defined in R4-23-701.04 in a hospice inpatient facility.
F. Drugs previously dispensed to a patient of the hospice inpa-
tient facility by another pharmacy, and drugs previously dis-
pensed by the provider pharmacy, shall not be repackaged.
Historical Note
Former Rules 6.8210, 6.8211, 6.8212, 6.8213, 6.8214,
6.8221, 6.8222, 6.8223, 6.8824, 6.8231, 6.8232, 6.8233,
6.8241, 6.8242, and 6.8243; Amended effective August
10, 1978 (Supp. 78-4). Repealed effective December 18,
1992 (Supp. 92-4). New Section made by final rulemak-
ing at 19 A.A.R. 2894, effective November 10, 2013
(Supp. 13-3).
R4-23-703. Assisted Living Facilities
A. Before dispensing, selling, or delivering a prescription or non-
prescription drug to an assisted living facility resident, a phar-
macy permittee shall verify the assisted living facility has a
current and active license issued by the Arizona Department of
Health Services.
B. A pharmacy permittee shall ensure that, except as provided
under subsection (C):
1. A controlled substance prescription drug is dispensed,
sold, or delivered to an assisted living facility resident
only after receiving a valid prescription order for the con-
trolled substance prescription drug from the resident's
medical practitioner; and
2. The controlled substance prescription drug is labeled in
accordance with A.R.S. §§ 32-1963.01, 32-1968, and 36-
2525 and includes the beyond-use date on the label.
C. A pharmacy permittee may dispense, sell, or deliver to an
assisted living facility resident a Schedule III, IV, or V con-
trolled substance prescription if the pharmacy permittee:
1. Receives a written or oral prescription order for the
Schedule III, IV, or V controlled substance from:
a. The resident’s medical practitioner,
b. An individual licensed by the Arizona Board of
Nursing who is acting within the scope of practice of
the individual’s license, or
c. The manager or a caregiver of the assisted living
facility if the resident’s medical practitioner has a
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 74 Supp. 20-1 March 31, 2020
written agreement with the assisted living facility
designating a representative of the assisted living
facility as an agent of the medical practitioner and a
licensed medical practitioner provided the prescrip-
tion order;
2. Complies with subsection (D)(2); and
3. Labels the Schedule III, IV, or V controlled substance as
specified under subsection (B)(2).
D. A pharmacy permittee may dispense, sell, or deliver to an
assisted living facility resident a non-controlled substance pre-
scription or non-prescription drug if the pharmacy permittee:
1. Receives a written or oral prescription order for the non-
controlled substance prescription or non-prescription
drug from:
a. The resident’s medical practitioner,
b. An individual licensed by the Arizona Board of
Nursing who is acting within the scope of practice of
the individual’s license, or
c. An assisted living facility manager or caregiver act-
ing under the authority of a licensed medical practi-
tioner;
2. Determines the written or oral prescription order:
a. Meets the requirements of R4-23-407, and
b. Includes the name and title of the individual trans-
mitting the prescription order; and
3. Labels the non-narcotic prescription or non-prescription
drug in accordance with A.R.S. §§ 32-1963.01 and 32-
1968 and includes the beyond-use date on the label.
E. If the label on an assisted living facility resident's drug con-
tainer becomes damaged or soiled, a pharmacist employed by
the pharmacy permittee that dispensed the drug container,
through the exercise of professional judgment, may relabel the
drug container. Only a pharmacist is permitted to label a drug
container or alter the label of a drug container.
F. A pharmacist may help assisted living facility personnel
develop written policies and procedures regarding procuring,
administering, storing, controlling, keeping records, and dis-
posing of drugs in the facility and provide information con-
cerning safe and effective supervision of drug self-
administration.
G. A pharmacy permittee shall not place an emergency drug sup-
ply unit as described in R4-23-701.02 or an automated dis-
pensing system as described in R4-23-701.04 in an assisted
living facility.
H. A pharmacist shall not repackage a drug previously dispensed
to an assisted living facility resident.
Historical Note
Former Rules 6.8310, 6.8320, 6.8330, 6.8340, 6.8350,
6.8360, and 6.8370; Amended effective August 10, 1978
(Supp. 78-4). Amended by final rulemaking at 5 A.A.R.
2561, effective July 16, 1999 (Supp. 99-3). Amended by
final rulemaking at 19 A.A.R. 2894, effective November
10, 2013 (Supp. 13-3). Amended by final rulemaking at
23 A.A.R. 2424, effective October 14, 2017 (Supp. 17-3).
R4-23-704. Customized Patient Medication Packages
In lieu of dispensing two or more prescribed drugs in separate con-
tainers, a pharmacist may, with the consent of the patient, the
patient’s caregiver, the prescriber, or the facility caring for the
patient, provide a customized patient medication package. The
pharmacist preparing a customized patient medication package
shall abide by the guidelines set forth in the current edition of the
official compendium for labeling, packaging, and recordkeeping,
and state and federal law.
Historical Note
Former Rules 6.8410, 6.8411, 6.8412, 6.8413, 6.8414,
6.8415, 6.8416, and 6.8417. Section R4-23-704 repealed
by final rulemaking at 5 A.A.R. 862, effective March 3,
1999 (Supp. 99-1). Amended by final rulemaking at 19
A.A.R. 2894, effective November 10, 2013 (Supp. 13-3).
R4-23-705. Repealed
Historical Note
Former Rules 6.8420, 6.8421, 6.8422, 6.8423, 6.8424,
6.8425, 6.8426, 6.8427, 6.8428, and 6.8429. Amended
effective August 10, 1978 (Supp. 78-4). Amended effec-
tive August 24, 1992 (Supp. 92-3). Repealed effective
December 18, 1992 (Supp. 92-4).
R4-23-706. Repealed
Historical Note
Former Rules 6.8431, 6.8432, 6.8433, 6.8434, 6.8435,
6.8436, and 6.8437; Amended effective August 10, 1978
(Supp. 78-4). Amended subsections (C), (E), (F), and (G)
effective April 20, 1982 (Supp. 82-2). Section R4-23-706
repealed by final rulemaking at 5 A.A.R. 862, effective
March 3, 1999 (Supp. 99-1).
R4-23-707. Repealed
Historical Note
Former Rules 6.8441, 6.8442, 6.8450, 6.8451, 6.8452,
6.8453, 6.8454, 6.8455, 6.8456, and 6.8457. Section R4-
23-707 repealed by final rulemaking at 5 A.A.R. 862,
effective March 3, 1999 (Supp. 99-1).
R4-23-708. Repealed
Historical Note
Former Rules 6.8461, 6.8462, 6.8463, and 6.8464. Sec-
tion R4-23-708 repealed by final rulemaking at 5 A.A.R.
862, effective March 3, 1999 (Supp. 99-1).
R4-23-709. Repealed
Historical Note
Former Rules 6.8471, 6.8472, and 6.8473. Section R4-
23-709 repealed by final rulemaking at 5 A.A.R. 862,
effective March 3, 1999 (Supp. 99-1).
ARTICLE 8. DRUG CLASSIFICATION
Article 8, consisting of Sections R4-23-801 and R4-23-802,
recodified from Article 5 at 9 A.A.R. 4011, effective August 18, 2003
(Supp. 03-3).
R4-23-801. Repealed
Historical Note
Former Rules 7.1110, 7.1120, and 7.1130. Repealed
effective November 4, 1998 (Supp. 98-4). Recodified
from R4-23-501 at 9 A.A.R. 4011, effective August 18,
2003 (Supp. 03-3). Repealed by final rulemaking at 26
A.A.R. 223, effective March 14, 2020 (Supp. 20-1).
R4-23-802. Veterinary
Veterinary preparation: A veterinary drug manufacturer or supplier
may distribute:
1. A prescription-only veterinary drug to:
a. A veterinary medical practitioner licensed under
A.R.S. Title 32, Chapter 21,
b. A full-service drug wholesaler permitted under
A.R.S. Title 32, Chapter 18, or
c. A pharmacy permitted under A.R.S. Title 32, Chap-
ter 18, and
2. A nonprescription veterinary drug to:
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 75
a. A veterinary medical practitioner licensed under
A.R.S. Title 32, Chapter 21,
b. A nonprescription drug retailer permitted under
A.R.S. Title 32, Chapter 18,
c. A full-service or nonprescription drug wholesaler
permitted under A.R.S. Title 32, Chapter 18, or
d. A pharmacy permitted under A.R.S. Title 32, Chap-
ter 18.
Historical Note
Former Rules 7.1210, 7.1220, and 7.1230. Repealed
effective November 4, 1998 (Supp. 98-4). Recodified
from R4-23-502 at 9 A.A.R. 4011, effective August 18,
2003 (Supp. 03-3).
R4-23-803. Repealed
Historical Note
Former Rules 7.1300, 7.1400, 7.1500, and 7.1000.
Repealed effective November 4, 1998 (Supp. 98-4).
R4-23-804. Repealed
Historical Note
Former Rules 7.2100, 7.2200, 7.2300, 7.2410, 7.2420,
and 7.2430. Repealed effective November 4, 1998 (Supp.
98-4).
ARTICLE 9. PENALTIES AND MISCELLANEOUS
R4-23-901. Penalty for Violations
Any person, firm, or corporation violating any provision of 4
A.A.C. 23 is subject to the penalties in A.R.S. § 32-1996. In addi-
tion, a license or permit issued under the provisions of A.R.S. Title
32, Chapter 18 is subject to suspension or revocation for violation
of 4 A.A.C. 23.
Historical Note
Former Rule 9.0000. Amended by final rulemaking at 6
A.A.R. 3177, effective August 3, 2000 (Supp. 00-3).
ARTICLE 10. UNIFORM CONTROLLED SUBSTANCES
AND DRUG OFFENSES
R4-23-1001. Repealed
Historical Note
Adopted effective August 2, 1982 (Supp. 82-4). Section
repealed by final rulemaking at 6 A.A.R. 3177, effective
August 3, 2000 (Supp. 00-3).
R4-23-1002. Repealed
Historical Note
Adopted effective August 2, 1982 (Supp. 82-4). Repealed
effective November 4, 1998 (Supp. 98-4).
R4-23-1003. Records and Order Forms
A. Records.
1. If the pharmacist-in-charge of a pharmacy is replaced by
another pharmacist-in-charge, the new pharmacist-in-
charge shall complete an inventory of all controlled sub-
stances in the pharmacy within 10 days of assuming the
responsibility. This inventory and any other required con-
trolled substance inventory shall:
a. Include an exact count of all Schedule II controlled
substances;
b. Include an exact count of all Schedule III through
Schedule V controlled substances or an estimated
count if the stock container contains fewer than 1001
units;
c. Indicate the date the inventory is taken and whether
the inventory is taken before opening of business or
after close of business for the pharmacy;
d. Be signed by:
i. The pharmacist-in-charge; or
ii. For other required inventories, the pharmacist who does
the inventory;
e. Be kept separately from all other records; and
f. Be available in the pharmacy for inspection by the
Board or its designee for not less than three years.
2. A loss of a controlled substance shall be reported:
a. Within 10 days of discovery;
b. On a DEA form 106;
c. By the pharmacist-in-charge of a pharmacy or a
manufacturer;
d. By the permittee or designated representative of a
full-service wholesaler; and
e. To the federal Drug Enforcement Administration
(DEA), the Narcotic Division of the Department of
Public Safety (DPS), and the Board of Pharmacy. A
copy of the DEA form 106 shall be kept on file by
the pharmacy permittee. The DEA form 106 shall
state whether the police investigated the loss.
3. Every person manufacturing any controlled substance,
including repackaging or relabeling, shall record and
retain for not less than three years the manufacturing,
repackaging, or relabeling date for each controlled sub-
stance.
4. Every person receiving, selling, delivering, or disposing
of any controlled substance shall record and retain for not
less than three years the following information:
a. The name, strength, dosage form, and quantity of
each controlled substance received, sold, delivered,
or disposed;
b. The name, address, and DEA registration number of
the person from whom each controlled substance is
received;
c. The name, address, and DEA registration number of
the person to whom each controlled substance is
sold or delivered or who disposes of each controlled
substance; and
d. The date of each transaction.
5. A full-service drug wholesale permittee or the designated
representative shall complete an inventory of all con-
trolled substances in the manner prescribed in subsection
(A)(1). The permittee or designated representative shall
conduct this inventory:
a. On May 1 of each year or as directed by the Board;
and
b. If there is a change of ownership, or discontinuance
of business, or within 10 days of a change of a desig-
nated representative.
6. A drug manufacturer permittee or the pharmacist-in-
charge shall complete an inventory of all controlled sub-
stances in the manner prescribed in subsection (A)(1).
The permittee or pharmacist-in-charge shall conduct this
inventory:
a. On May 1 of each year or as directed by the Board;
and
b. If there is a change of ownership, or discontinuance
of business, or within 10 days of a change of a phar-
macist-in-charge.
B. Order form. For purposes of A.R.S. § 36-2524, “Order Form”
means DEA Form 222c.
Historical Note
Adopted effective August 2, 1982 (Supp. 82-4).
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 76 Supp. 20-1 March 31, 2020
Amended effective November 1, 1993 (Supp. 93-4).
Amended effective April 1, 1995; filed January 31, 1995
(Supp. 95-1). Amended by final rulemaking at 6 A.A.R.
3177, effective August 3, 2000 (Supp. 00-3). Amended
by final rulemaking at 12 A.A.R. 1912, effective July 1,
2006 (Supp. 06-2). Amended by final rulemaking at 14
A.A.R. 3670, effective November 8, 2008 (Supp. 08-3).
R4-23-1004. Repealed
Historical Note
Adopted effective August 2, 1982 (Supp. 82-4). Repealed
effective November 4, 1998 (Supp. 98-4).
R4-23-1005. Substances Excepted from the Schedules of Con-
trolled Substances
A. All over-the-counter non-narcotic substances containing lim-
ited amounts of controlled substances that are excluded from
all controlled substance schedules by 21 CFR 1308.22
(Revised April 1, 2012, incorporated by reference and on file
with the Board. This incorporated material contains no future
editions or amendments.), are excluded from all controlled
substance schedules in Arizona.
B. All chemical preparations or mixtures containing one or more
controlled substances listed in any schedule that are exempted
from all controlled substance schedules by 21 CFR 1308.24
(Revised April 1, 2012, incorporated by reference and on file
with the Board. This incorporated material contains no future
editions or amendments.), are excluded from all controlled
substance schedules in Arizona.
C. All prescription-only drugs that are exempted by 21 CFR
1308.32 (Revised April 1, 2012, incorporated by reference and
on file with the Board. This incorporated material contains no
future editions or amendments.), are excluded from all con-
trolled substance schedules in Arizona.
Historical Note
Adopted effective August 2, 1982 (Supp. 82-4).
Amended by final rulemaking at 6 A.A.R. 3177, effective
August 3, 2000 (Supp. 00-3). Amended by final rulemak-
ing at 18 A.A.R. 2609, effective December 2, 2012
(Supp. 12-4).
R4-23-1006. Substances Excepted from Drug Offenses
The following materials, compounds, mixtures, or preparations
containing any stimulant or depressant substance included in
A.R.S. §§ 13-3401(6)(b) or 13-3401(6)(c) are excepted from the
definition of dangerous drugs under the authority of A.R.S. § 32-
1904(B)(14):
1. Over-the-counter drugs excepted in R4-23-1005(A).
2. Chemical preparations excepted in R4-23-1005(B).
3. Prescription-only drugs excepted in R4-23-1005(C).
Historical Note
Adopted effective August 2, 1982 (Supp. 82-4).
Amended by final rulemaking at 6 A.A.R. 3177, effective
August 3, 2000 (Supp. 00-3).
ARTICLE 11. PHARMACY TECHNICIANS
Article 11, consisting of R4-23-1101 through R4-23-1105,
made by final rulemaking at 10 A.A.R. 1192, effective May 1, 2004
(Supp. 04-1).
R4-23-1101. Licensure and Eligibility
A. License required. A person shall not work as a pharmacy tech-
nician or pharmacy technician trainee in Arizona, unless the
person possesses a pharmacy technician or pharmacy techni-
cian trainee license issued by the Board.
B. Eligibility.
1. To be eligible for licensure as a pharmacy technician
trainee, a person shall:
a. Be of good moral character,
b. Be at least 18 years of age, and
c. Have a high school diploma or the equivalent of a
high school diploma.
2. To be eligible for licensure as a pharmacy technician, a
person shall:
a. Meet the requirements of subsection (B)(1),
b. Complete a pharmacy technician training program
that meets the standards prescribed in R4-23-1105,
and
c. Pass the Pharmacy Technician Certification Board
(PTCB) examination or another Board-approved
pharmacy technician examination.
C. A pharmacy technician delinquent license. Before an Arizona
pharmacy technician license will be reinstated, a pharmacy
technician whose Arizona pharmacy technician license is
delinquent for five or more consecutive years shall furnish to
the Board satisfactory proof of fitness to be licensed as a phar-
macy technician and pay all past due biennial renewal fees and
penalty fees. Satisfactory proof includes:
1. For a person with a delinquent license who is practicing
as a pharmacy technician out-of-state with a pharmacy
technician license issued by another jurisdiction:
a. Proof of current, unrestricted pharmacy technician
licensure in another jurisdiction; and
b. Proof of employment as a pharmacy technician
during the last 12 months; or
2. For a person with a delinquent license who did not prac-
tice as a pharmacy technician within the last 12 months:
a. Take and pass a Board-approved pharmacy techni-
cian examination, and
b. Complete 20 contact hours or two CEUs of continu-
ing education activity sponsored by an approved
provider, including at least two contact hours or 0.2
CEUs of continuing education activity in pharmacy
law.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1192, effective May 1, 2004 (Supp. 04-1). Amended by
final rulemaking at 19 A.A.R. 102, effective March 10,
2013 (Supp. 13-1).
R4-23-1102. Pharmacy Technician Licensure
A. Eligibility. An applicant for licensure as a pharmacy techni-
cian shall provide the Board proof the applicant is eligible
under R4-23-1101(B)(2), including documentation that the
applicant:
1. Completed a pharmacy technician training program that
meets the standards prescribed in R4-23-1105(B)(2); and
2. Passed the Pharmacy Technician Certification Board
(PTCB) examination or another Board-approved phar-
macy technician examination; or
3. Meets the requirements of R4-23-1105(D)(1) or (2).
B. Application.
1. An applicant for licensure as a pharmacy technician shall:
a. Submit a completed application electronically or
manually on a form furnished by the Board, and
b. Submit with the application form:
i. The documents specified in the application
form,
ii. The initial licensure fee specified in R4-23-
205, and
iii. The wall license fee specified in R4-23-205.
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 77
2. The Board office shall deem an application form received
on the date the Board office electronically or manually
date-stamps the form.
C. Licensure.
1. If an applicant is found to be ineligible for pharmacy
technician licensure under statute and rule, the Board
office shall issue a written notice of denial to the appli-
cant.
2. If an applicant is found to be eligible for pharmacy tech-
nician licensure under statute and rule, the Board office
shall issue a certificate of licensure and a wall license. An
applicant who is assigned a license number and who has
been granted “open” status on the Board’s license verifi-
cation site may begin practice as a pharmacy technician
before receiving the certificate of licensure.
3. An applicant who is assigned a license number and who
has a “pending” status on the Board’s license verification
site shall not practice as a pharmacy technician until the
Board office issues a certificate of licensure as specified
in subsection (C)(2).
4. A licensee shall maintain the certificate of licensure in the
practice site for inspection by the Board or its designee or
review by the public.
D. License renewal.
1. To renew a license, a pharmacy technician shall submit a
completed license renewal application electronically or
manually on a form furnished by the Board with the bien-
nial renewal fee specified in R4-23-205.
2. If the biennial renewal fee is not paid by November 1 of
the renewal year specified in A.R.S. § 32-1925, the phar-
macy technician license is suspended and the licensee
shall not practice as a pharmacy technician. The licensee
shall pay a penalty as provided in A.R.S. § 32-1925 and
R4-23-205 to vacate the suspension.
3. A licensee shall maintain the renewal certificate of licen-
sure in the practice site for inspection by the Board or its
designee or review by the public.
E. Time frames for pharmacy technician licensure and license
renewal. The Board office shall follow the time frames estab-
lished in R4-23-202(F).
F. Verification of license. A pharmacy permittee or pharmacist-
in-charge shall not permit a person to practice as a pharmacy
technician until the pharmacy permittee or pharmacist-in-
charge verifies the person is currently licensed by the Board as
a pharmacy technician.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1192, effective May 1, 2004 (Supp. 04-1). Amended by
final rulemaking at 19 A.A.R. 102, effective March 10,
2013 (Supp. 13-1). Amended by final rulemaking at 19
A.A.R. 2911, effective November 10, 2013 (Supp. 13-3).
Amended by final rulemaking at 25 A.A.R. 1015, effec-
tive June 1, 2019 (Supp. 19-2).
R4-23-1103. Pharmacy Technician Trainee Licensure
A. Eligibility. An applicant for licensure as a pharmacy techni-
cian trainee shall provide the Board proof the applicant is eli-
gible under R4-23-1101(B)(1).
B. Application.
1. An applicant for licensure as a pharmacy technician
trainee shall:
a. Submit a completed application electronically or
manually on a form furnished by the Board, and
b. Submit with the application form:
i. The documents specified in the application
form,
ii. The licensure fee specified in R4-23-205, and
iii. The wall license fee specified in R4-23-205.
2. The Board office shall deem an application form received
on the date the Board office electronically or manually
date-stamps the form.
C. Licensure.
1. If an applicant is found to be ineligible for pharmacy
technician trainee licensure under statute and rule, the
Board office shall issue a written notice of denial to the
applicant.
2. If an applicant is found to be eligible for pharmacy tech-
nician trainee licensure under statute and rule, the Board
office shall issue a certificate of licensure and a wall
license. An applicant who is assigned a license number
and who has been granted “open” status on the Board’s
license verification site may begin practice as a pharmacy
technician trainee before receiving the certificate of licen-
sure.
3. An applicant who is assigned a license number and who
has a “pending” status on the Board’s license verification
site shall not practice as a pharmacy technician trainee
until the Board office issues a certificate of licensure as
specified in subsection (C)(2).
4. A licensee shall maintain the certificate of licensure in the
practice site for inspection by the Board or its designee or
review by the public.
5. A pharmacy technician trainee license is valid for 36
months from the date issued. A pharmacy technician
trainee who does not complete the prescribed training
program and pass a Board-approved pharmacy technician
examination before the pharmacy technician trainee’s
license expires is not eligible for licensure as a pharmacy
technician and shall not practice as a pharmacy technician
or pharmacy technician trainee. The Board has approved
the following pharmacy technician examinations:
a. Pharmacy Technician Certification Board (PTCB)
Exam, and
b. Exam for the Certification of Pharmacy Technicians
(ExCPT).
D. Time frames for pharmacy technician trainee licensure. The
Board office shall follow the time frames established in R4-
23-202(F).
E. Verification of license. A pharmacy permittee or pharmacist-
in-charge shall not permit a person to practice as a pharmacy
technician trainee until the pharmacy permittee or pharmacist-
in-charge verifies that the person is currently licensed by the
Board as a pharmacy technician trainee.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1192, effective May 1, 2004 (Supp. 04-1). Amended by
final rulemaking at 19 A.A.R. 2911, effective November
10, 2013 (Supp. 13-3). Amended by final rulemaking at
25 A.A.R. 1015, effective June 1, 2019 (Supp. 19-2).
Amended by final rulemaking at 26 A.A.R. 223, effective
March 14, 2020 (Supp. 20-1).
R4-23-1104. Pharmacy Technicians and Pharmacy Technician
Trainees
A. Permissible tasks of a pharmacy technician trainee. Acting in
compliance with all applicable statutes and rules and under the
supervision of a pharmacist, a pharmacy technician trainee
licensed under R4-23-1103 may assist a graduate intern, phar-
macy intern, or pharmacist with the following when applicable
to the pharmacy practice site:
1. Record on the original prescription order the serial num-
ber of the prescription medication and date dispensed;
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 78 Supp. 20-1 March 31, 2020
2. Initiate or accept verbal or electronic refill authorization
from a medical practitioner or medical practitioner’s
agent and record, on the original prescription order or by
an alternative method approved by the Board or its desig-
nee, the medical practitioner’s name, patient name, name
and quantity of prescription medication, specific refill
information, and name of medical practitioner’s agent, if
any;
3. Record information in the refill record or patient profile;
4. Enter information for a new or refill prescription medica-
tion as required under A.R.S. § 32-1964;
5. Type and affix a label for the prescription medication. A
pharmacist or graduate or pharmacy intern working under
the supervision of a pharmacist shall verify the accuracy
of the label as described under R4-23-402(A)(11);
6. Reconstitute a prescription medication, if a pharmacist
checks the ingredients and procedure before reconstitu-
tion and verifies the final product after reconstitution;
7. Retrieve, count, or pour a prescription medication, if a
pharmacist verifies the contents of the prescription medi-
cation against the original prescription medication con-
tainer or by an alternative drug identification method
approved by the Board or its designee;
8. Prepackage drugs in accordance with R4-23-402(A); and
9. Measure, count, pour, or otherwise prepare and package a
drug needed for hospital inpatient dispensing, if a phar-
macist verifies the accuracy, measuring, counting, pour-
ing, preparing, packaging, and safety of the drug before
the drug is delivered to a patient care area.
B. Permissible tasks of a pharmacy technician. Acting in compli-
ance with all applicable statutes and rules and under the super-
vision of a pharmacist, a pharmacy technician licensed under
R4-23-1102 may:
1. Perform the tasks listed in subsection (A);
2. After completing a pharmacy technician drug compound-
ing training program developed by the pharmacy permit-
tee or pharmacist-in-charge under R4-23-1105(C), assist
a pharmacist, graduate intern, or pharmacy intern in com-
pounding prescription medications and sterile or non-
sterile pharmaceuticals in accordance with written poli-
cies and procedures, if the preparation, accuracy, and
safety of the final product is verified by a pharmacist
before dispensing;
3. Perform a final technology-assisted verification of prod-
uct if the pharmacy technician is qualified under R4-23-
1104.01(D); and
4. If technology-assisted verification is performed, type and
affix a label for the prescription medication. A pharmacist
or graduate or pharmacy intern shall verify the accuracy
of the label as described under R4-23-402(A)(12).
C. A trained and licensed pharmacy technician or pharmacy tech-
nician trainee who performs a task as authorized under subsec-
tions (A) and (B) shall ensure the task is performed accurately.
D. Prohibited activities. A pharmacy technician or pharmacy
technician trainee shall not perform a professional practice
reserved for a pharmacist, graduate intern, or pharmacy intern
in accordance with R4-23-402 or R4-23-653.
E. A pharmacy technician or pharmacy technician trainee shall
wear a badge indicating name and title while on duty.
F. Before employing a pharmacy technician or pharmacy techni-
cian trainee, a pharmacy permittee or pharmacist-in-charge
shall develop, implement, review, and revise in the manner
described in R4-23-653(A) and comply with policies and pro-
cedures outlined in subsection (G) for pharmacy technician
and pharmacy technician trainee tasks.
G. A pharmacy permittee or pharmacist-in-change shall ensure
policies and procedures required under subsection (F) include
the following:
1. For all practice sites:
a. Supervisory controls and verification procedures to
ensure the quality and safety of pharmaceutical ser-
vice;
b. Employment performance expectations for a phar-
macy technician and pharmacy technician trainee;
c. The tasks a pharmacy technician or pharmacy tech-
nician trainee may perform as specified under sub-
sections (A) and (B);
d. Pharmacist and patient communication;
e. Reporting, correcting, and avoiding medication and
dispensing errors;
f. Security procedures for:
i. Confidentiality of patient prescription records,
and
ii. The pharmacy area;
g. Automated medication distribution system;
h. Compounding procedures for pharmacy technicians;
and
i. Brief overview of state and federal pharmacy stat-
utes and rules;
2. For community and limited-service pharmacy practice
sites:
a. Prescription dispensing procedures for:
i. Accepting a new written prescription order,
ii. Accepting a refill request,
iii. Selecting a drug product,
iv. Counting and pouring,
v. Labeling, and
vi. Obtaining refill authorization; and
b. Computer data-entry procedures for:
i. New and refill prescriptions,
ii. Patient’s drug allergies,
iii. Drug-drug interactions,
iv. Drug-food interactions,
v. Drug-disease state contraindications,
vi. Refill frequency,
vii. Patient’s disease and medical condition,
viii. Patient’s age or date of birth and gender, and
ix. Patient profile maintenance; and
3. For hospital pharmacy practice sites:
a. Medication order procurement and data entry,
b. Drug preparation and packaging,
c. Outpatient and inpatient drug delivery, and
d. Inspection of drug storage and preparation areas and
patient care areas.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1192, effective May 1, 2004 (Supp. 04-1). Amended by
final rulemaking at 12 A.A.R. 3032, effective October 1,
2006 (Supp. 06-3). Amended by final rulemaking at 19
A.A.R. 102, effective March 10, 2013 (Supp. 13-1).
Amended by final rulemaking at 23 A.A.R. 3257, effec-
tive January 8, 2018 (Supp. 17-4).
R4-23-1104.01 Technology-assisted Verification of Product
A. By complying with this Section, the permittee of a retail, insti-
tutional, or limited-service pharmacy may implement a tech-
nology-assisted verification of product program that allows a
pharmacy technician licensed under R4-23-1102 and qualified
under subsection (D) to perform final product verification.
B. Written program description required. Before implementing a
technology-assisted verification of product program the per-
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 79
mittee of a retail, institutional, or limited-service pharmacy
shall prepare a written program description that includes the
following:
1. Responsibility of both the pharmacist in charge and per-
mittee to ensure compliance with this Section;
2. Responsibility of the permittee to design, implement, and
monitor a process that ensures the accuracy and safety of
the product dispensed;
3. Duties of a verification technician;
4. The training necessary to qualify and remain qualified as
a verification technician;
5. The monitoring and evaluation procedures to be used to
ensure competency of the verification technician; and
6. Prohibition of a verification technician performing a final
accuracy check of a completed prescription label.
C. The permittee of a retail, institutional, or limited-service phar-
macy implementing a technology-assisted verification of prod-
uct program shall:
1. Post the written program description required under sub-
section (B) in the pharmacy area;
2. Provide a copy of the written program description to the
pharmacist in charge and verification technician;
3. Obtain the signature of the pharmacist in charge and veri-
fication technician on a copy of the written program
description and place the signed copy in the personnel file
of the pharmacist in charge and verification technician;
4. Ensure scanning technology used in the technology-
assisted verification program captures both product and
patient information; and
5. Update the written program description as needed and
repeat subsections (C)(1) through (4) after each update.
D. Verification technician training: The permittee of a retail, insti-
tutional, or limited-service pharmacy implementing a technol-
ogy-assisted verification of product program shall ensure a
pharmacy technician does not perform the duties of a verifica-
tion technician unless the pharmacy technician has the follow-
ing qualifications:
1. Is licensed under R4-23-1102;
2. Has at least 1,000 hours of pharmacy technician work
experience in the same kind of pharmacy practice site in
which the technology-assisted verification of product will
be performed;
3. Completes a training program that includes at least the
following:
a. Role of a verification technician in the dispensing
process,
b. Legal requirements of a verification technician,
c. How to use the technology-assisted verification sys-
tem,
d. Primary causes of medication errors, and
e. Identifying and resolving dispensing errors; and
4. Completes at least four hours of the continuing education
required under R4-23-1106 on patient safety.
E. The permittee of a retail, institutional, or limited-service phar-
macy implementing a technology-assisted verification of prod-
uct program shall ensure the pharmacy practice site has a
computer data storage and retrieval system that meets the stan-
dards in R4-23-408(B).
F. The permittee of a retail, institutional, or limited-service phar-
macy implementing a technology-assisted verification of prod-
uct program shall ensure a verification technician verifies only
the following:
1. A product with scanning technology that identifies prod-
uct, or
2. A robotically prepared unit-dose product.
G. The permittee of a retail, institutional, or limited-service phar-
macy implementing a technology-assisted verification of prod-
uct program shall ensure a verification technician does not
verify the following:
1. A product that involves a combination of drugs resulting
from compounding or mixing two or more ingredients or
products,
2. A product that involves or results from an alteration of a
drug, or
3. A DEA schedule II controlled substance.
H. The permittee of a retail, institutional, or limited-service phar-
macy implementing a technology-assisted verification of prod-
uct program shall perform an unannounced evaluation of the
competency of a verification technician at least twice a year
and take steps to remediate any deficiencies identified includ-
ing removing verification duties from the technician.
I. The permittee of a retail, institutional, or limited-service phar-
macy implementing a technology-assisted verification of prod-
uct program shall maintain the following records:
1. Date the pharmacy technician was designated as a verifi-
cation technician,
2. Date the pharmacy technician completed the training
required under subsection (D)(3),
3. Dates and results of the evaluations conducted under sub-
section (H), and
4. Date and reason for any disciplinary action against the
verification technician arising from performing the duties
of a verification technician.
J. A verification technician shall wear identification that includes
the title “Verification Technician” while on duty.
K. As used in this Section, the term “verification technician”
means an individual who:
1. Is qualified under subsection (D),
2. Uses a combination of scanning technology and visual
confirmation to verify a product prepared to be dispensed
is the product prescribed and indicated on the prescription
label, and
3. Performs verification of work performed by other phar-
macy technicians before a pharmacist or graduate or
pharmacy intern working under the supervision of a phar-
macist performs the final accuracy check required under
R4-23-402(A).
Historical Note
New Section made by final rulemaking at 23 A.A.R.
3257, effective January 8, 2018 (Supp. 17-4).
R4-23-1105. Pharmacy Technician Trainee Training Program,
Pharmacy Technician Drug Compounding Training Program,
and Alternative Pharmacy Technician Training
A. Nothing in this Section prevents additional offsite training of a
pharmacy technician.
B. Pharmacy technician trainee training program.
1. A pharmacy permittee or pharmacist-in-charge shall
develop, implement, review, revise in the same manner
described in R4-23-653(A), and comply with a pharmacy
technician trainee training program based on the needs of
the individual pharmacy.
2. A pharmacy permittee or pharmacist-in-charge shall
ensure the pharmacy technician trainee training program
includes training guidelines that:
a. Define the specific tasks a pharmacy technician
trainee is expected to perform,
b. Specify how and when the pharmacist-in-charge will
assess the pharmacy technician trainee’s compe-
tency, and
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 80 Supp. 20-1 March 31, 2020
c. Address the policies and procedures specified in R4-
23-1104(G) and the permissible activities specified
in R4-23-1104(A).
3. A pharmacist-in-charge shall:
a. Document the date a pharmacy technician trainee
successfully completed the training program, and
b. Maintain the documentation required in this subsec-
tion for inspection by the Board or its designee.
4. A pharmacy technician trainee shall perform only those
tasks, listed in R4-23-1104(A), for which training and
competency has been demonstrated.
C. Pharmacy technician drug compounding training program.
1. A pharmacy permittee or pharmacist-in-charge shall
develop, implement, review, revise in the same manner
described in R4-23-653(A), and comply with a pharmacy
technician drug compounding training program based on
the needs of the individual pharmacy;
2. A pharmacy permittee or pharmacist-in-charge shall
ensure the pharmacy technician drug compounding train-
ing program includes training guidelines that:
a. Define the specific tasks a pharmacy technician is
expected to perform,
b. Specify how and when the pharmacist-in-charge will
assess the pharmacy technician’s competency, and
c. Address the following procedures and tasks:
i. Area preparation,
ii. Component preparation,
iii. Aseptic technique and product preparation,
iv. Packaging and labeling, and
v. Area cleanup;
3. A pharmacist-in-charge shall:
a. Document the date a pharmacy technician success-
fully completed the pharmacy technician drug com-
pounding training program, and
b. Maintain the documentation required in this subsec-
tion for inspection by the Board or its designee.
D. Alternative pharmacy technician training.
1. An individual who has passed the required Board-
approved pharmacy technician examination, but has not
followed the normal path to pharmacy technician licen-
sure by obtaining a pharmacy technician trainee license
and working while completing a pharmacy technician
trainee training program as specified in subsection (B),
may obtain a pharmacy technician license, if the individ-
ual has employment in pharmacy and completes an on-
the-job training program as part of the individual’s
employment orientation that includes: reading and dis-
cussing with the pharmacist-in-charge of the pharmacy
where employed, the Board rules concerning pharmacy
technicians and pharmacy technician trainees, the phar-
macy technician and pharmacy technician trainee job
description, and the policies and procedures manual of
that pharmacy.
2. An individual who has completed a pharmacy technician
certificate program and has passed the required Board-
approved pharmacy technician examination, but has not
followed the normal path to pharmacy technician licen-
sure by obtaining a pharmacy technician trainee license
and working while completing a pharmacy technician
trainee training program as specified in subsection (B),
may obtain a pharmacy technician license, if the individ-
ual has employment in pharmacy and completes an on-
the-job training program as part of the individual’s
employment orientation that includes: reading and dis-
cussing with the pharmacist-in-charge of the pharmacy
where employed, the Board rules concerning pharmacy
technicians and pharmacy technician trainees, the phar-
macy technician and pharmacy technician trainee job
description, and the policies and procedures manual of
that pharmacy.
3. A pharmacist-in-charge shall:
a. Document the date an individual licensed under sub-
section (D)(1) or (2) successfully completed the on-
the-job training program as part of the individual’s
employment orientation as required under subsec-
tion (D)(1) or (2), and
b. Maintain the documentation required in this subsec-
tion for inspection by the Board or its designee.
E. A pharmacy technician shall perform only those tasks, listed in
R4-23-1104(B), for which training and competency has been
demonstrated.
F. If a pharmacy technician leaves a training program described
under subsection (B), (C), or (D) before successfully complet-
ing the training program, the pharmacist-in-charge shall pro-
vide the pharmacy technician with written documentation of
the hours of training completed and the tasks for which com-
petence was demonstrated by the pharmacy technician.
Historical Note
New Section made by final rulemaking at 10 A.A.R.
1192, effective May 1, 2004 (Supp. 04-1). Amended by
final rulemaking at 12 A.A.R. 3032, effective October 1,
2006 (Supp. 06-3). Amended by final rulemaking at 19
A.A.R. 102, effective March 10, 2013 (Supp. 13-1).
Amended by final rulemaking at 25 A.A.R. 1015, effec-
tive June 1, 2019 (Supp. 19-2).
R4-23-1106. Continuing Education Requirements
A. General. According to A.R.S. § 32-1925(H), the Board shall
not renew a pharmacy technician license unless the licensee
has during the two years preceding the application for renewal:
1. Participated in 20 contact hours or two CEUs of continu-
ing education activity sponsored by an Approved Pro-
vider, as defined in R4-23-110, and
2. A pharmacy technician licensee is exempt from the con-
tinuing education requirement in subsection (A)(1)
between the time of initial licensure and first renewal.
B. Valid CEUs. The Board shall:
1. Accept CEUs for continuing education activities spon-
sored only by an Approved Provider;
2. Accept CEUs accrued during only the two-year period
immediately before licensure renewal;
3. Not allow CEUs accrued in a biennial renewal period to
be carried forward to the succeeding biennial renewal
period;
4. Allow a pharmacy technician who leads, instructs, or lec-
tures to a group of health professionals on pharmacy-
related topics in a continuing education activity spon-
sored by an Approved Provider to receive CEUs for a
presentation by following the same attendance proce-
dures as any other attendee of the continuing education
activity; and
5. Not accept as a CEU a pharmacy technician’s normal
teaching duties within a learning institution if the phar-
macy technician’s primary responsibility is the education
of health professionals.
C. Continuing education records and reporting CEUs. A phar-
macy technician shall:
1. Maintain continuing education records that:
a. Verify the continuing education activities the phar-
macy technician participated in during the preceding
five years; and
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 81
b. Consist of a statement of credit or a certificate issued
by an Approved Provider at the conclusion of a con-
tinuing education activity;
2. At the time of licensure renewal, attest to the number of
CEUs the pharmacy technician participated in during the
renewal period on the biennial renewal form; and
3. When requested by the Board office, submit proof of con-
tinuing education participation within 20 days of the
request.
D. The Board shall deem a pharmacy technician’s failure to com-
ply with the continuing education participation, recording, or
reporting requirements of this Section as unprofessional con-
duct and grounds for disciplinary action by the Board under
A.R.S. § 32-1927.01.
E. A pharmacy technician who is aggrieved by any decision of
the Board concerning continuing education units may request
a hearing before the Board.
Historical Note
New Section made by final rulemaking at 11 A.A.R.
1105, effective April 30, 2005 (Supp. 05-1). Amended by
final rulemaking at 26 A.A.R. 223, effective March 14,
2020 (Supp. 20-1).
ARTICLE 12. PRESCRIPTION MEDICATION DONATION
PROGRAM
R4-23-1201. Eligibility Requirements for Participation in the
Program
A physician’s office, a pharmacy, or a health care institution may
participate in the prescription medication donation program, under
A.R.S. § 32-1909, if all of the following requirements, as applica-
ble, are met:
1. The physician-in-charge of the participating physician’s
office has a current license issued under A.R.S. Title 32,
Chapter 13 or 17;
2. The pharmacy has a current permit issued under A.R.S.
Title 32, Chapter 18;
3. The health care institution has a current license issued
under A.R.S. Title 36, Chapter 4 and has a physician-in-
charge or pharmacist-in-charge of dispensing; and
4. The physician’s office, the pharmacy, or the health care
institution complies with all federal and state drug laws,
rules, and regulations.
Historical Note
New Section made by final rulemaking at 14 A.A.R.
4320, effective January 3, 2009 (Supp. 08-4).
R4-23-1202. Donating Medications
A. The following may donate an eligible prescription medication,
as specified in R4-23-1203, to a physician’s office, a phar-
macy, or a health care institution that participates in the pre-
scription medication donation program:
1. An individual for whom the prescription medication was
prescribed on a patient-specific prescription order or that
individual’s health care decision maker;
2. A manufacturer that has a current permit issued under
A.R.S. Title 32, Chapter 18; or
3. A health care institution that has a current license issued
under A.R.S. Title 36, Chapter 4.
B. An individual or health care decision maker electing to donate
an eligible prescription medication shall not have taken pos-
session of the prescription medication before the donation and
shall make the donation through a medical practitioner, phar-
macy, or health care institution.
Historical Note
New Section made by final rulemaking at 14 A.A.R.
4320, effective January 3, 2009 (Supp. 08-4).
R4-23-1203. Eligible Prescription Medications
A prescription medication may be donated to a physician’s office, a
pharmacy, or a health care institution that participates in the pre-
scription medication donation program if the prescription medica-
tion:
1. Is not a:
a. Controlled substance;
b. Drug sample; or
c. Drug that can only be dispensed to a patient regis-
tered with the drug’s manufacturer, because dona-
tion could prevent the manufacturer from
maintaining required patient registration data;
2. Is in its original sealed and tamper-evident unit dose
packaging that is unopened or has only its outside pack-
aging opened and its single unit dose packaging undis-
turbed;
3. Has been in the possession of a licensed health care pro-
fessional, manufacturer, pharmacy, or health care institu-
tion and not in the possession of the individual specified
in R4-23-1202(A)(1);
4. Has been stored according to federal and state drug law
and the requirements of the manufacturer’s package
insert;
5. Has an expiration date or beyond-use-date later than six
months after the date of donation;
6. Is in packaging that shows the lot number and expiration
date or beyond-use-date of the prescription medication;
7. Does not have any physical signs of tampering or adulter-
ation; and
8. Is in packaging that does not have any physical signs of
tampering, except for the outside packaging as specified
in subsection (2).
Historical Note
New Section made by final rulemaking at 14 A.A.R.
4320, effective January 3, 2009 (Supp. 08-4).
R4-23-1204. Eligibility Requirements to Receive Donated Pre-
scription Medications
An individual is eligible to receive donated prescription medica-
tions from the prescription medication donation program if the indi-
vidual:
1. Is a resident of Arizona;
2. Has an annual family income that is less than or equal to
300% of the poverty level;
3. Satisfies one of the following:
a. Has no health insurance coverage;
b. Has health insurance coverage that does not pay for
the prescription medication prescribed;
c. Is an American or Alaska Native who:
i. Is eligible for, but chooses not to use, the Indian
Health Service to receive prescription medica-
tions; and
ii. Either has no other health insurance coverage
or has health insurance coverage that does not
pay for the prescription medication prescribed;
or
d. Is a veteran who:
i. Is eligible for, but chooses not to use, Veterans
Health Administration benefits to receive pre-
scription medications; and
ii. Either has no other health insurance coverage
or has health insurance coverage that does not
pay for the prescription medication prescribed;
4. Is ineligible for enrollment in AHCCCS; and
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 82 Supp. 20-1 March 31, 2020
5. If eligible for Medicare, is ineligible for a full low-
income subsidy.
Historical Note
New Section made by final rulemaking at 14 A.A.R.
4320, effective January 3, 2009 (Supp. 08-4).
R4-23-1205. Donor Form
A. Before donating a prescription medication, a donor shall sign a
form that includes:
1. A statement attesting that the donor is one of the entities
identified in R4-23-1202(A) and intends to voluntarily
donate the prescription medication to the prescription
medication donation program;
2. If the donor is the individual named on the prescription or
the individual’s health care decision maker:
a. The individual’s name and address;
b. The name of the individual’s heath care decision
maker, if applicable;
c. The name of the medical practitioner, pharmacy, or
health care institution through which the donation is
being made;
d. The following information about the donated pre-
scription medication:
i. The brand name or generic name of the pre-
scription medication donated;
ii. If a generic medication, the name of the manu-
facturer or the national drug code number of the
prescription medication donated;
iii. The strength of the prescription medication
donated;
iv. The quantity of the prescription medication
donated;
v. The lot number of the prescription medication
donated; and
vi. The expiration date or beyond-use-date of the
prescription medication donated;
e. A statement attesting that the individual or the indi-
vidual’s health care decision maker has not had pos-
session of the donated prescription medication;
f. The dated signature of the individual or the individ-
ual’s health care decision maker;
g. If the donation is an ongoing donation as authorized
under subsection (B), a statement that conforms to
subsection (B);
h. A statement by the medical practitioner, pharmacy,
or health care institution attesting that the medical
practitioner, pharmacy, or health care institution
through which the donation is being made has stored
the donated prescription medication as required in
R4-23-1203(4);
i. A statement by the medical practitioner, pharmacy,
or health care institution attesting that the drugs
being donated meet the specific requirements of R4-
23-1203(1); and
j. The dated signature of the medical practitioner or of
an authorized agent for the pharmacy or health care
institution through which the donation is being
made;
3. If the donor is a manufacturer:
a. The name and address of the manufacturer;
b. The information about the donated prescription
medication specified in subsection (A)(2)(d);
c. A statement by the manufacturer that the manufac-
turer has stored the donated prescription medication
as required in R4-23-1203(4); and
d. The dated signature of the manufacturer’s autho-
rized agent; and
4. If the donor is a health care institution:
a. The name and address of the health care institution;
b. The information about the donated prescription
medication specified in subsection (A)(2)(d);
c. A statement attesting that the health care institution
has stored the donated prescription medication as
required in R4-23-1203(4);
d. A statement by the health care institution attesting
that the drugs being donated meet the specific
requirements of R4-23-1203(1); and
e. The dated signature of the health care institution’s
authorized agent.
B. An individual who resides in a health care institution, or the
individual’s health care decision maker, may elect to make an
ongoing donation of future unused eligible prescription medi-
cation:
1. When future unused eligible prescription medication is a
result of the individual’s prescription medication being
changed or discontinued by the individual’s primary care
provider; and
2. By indicating the following on a donor form that com-
plies with subsection (A): “From this day forward, I wish
to donate all my remaining unused prescription medica-
tions that are eligible, under R4-23-1203, to the prescrip-
tion medication donation program.”
C. To stop an ongoing donation, an individual who resides in a
health care institution, or the individual’s health care decision
maker, shall submit written notice to the receiving physician’s
office, pharmacy, or health care institution indicating the indi-
vidual’s, or the health care decision maker’s, desire to stop the
ongoing donation.
Historical Note
New Section made by final rulemaking at 14 A.A.R.
4320, effective January 3, 2009 (Supp. 08-4).
R4-23-1206. Recipient Form
Before receiving a donated prescription medication from the pre-
scription medication donation program, a recipient of a donated
prescription medication shall sign a form:
1. Identifying the physician’s office, pharmacy, or health
care institution that is dispensing the donated prescription
medication;
2. Stating that the recipient has been advised of and under-
stands the immunity provisions of the program under
A.R.S. § 32-1909(E) and (F);
3. Attesting that the recipient meets the eligibility require-
ments specified in R4-23-1204: and
4. Including the following:
a. The brand name or generic name of the prescription
medication received;
b. If a generic medication, the name of the manufac-
turer or the national drug code number of the pre-
scription medication received;
c. The strength of the prescription medication
received;
d. The quantity of the prescription medication
received;
e. The recipient’s name and address; and
f. The dated signature of the recipient.
Historical Note
New Section made by final rulemaking at 14 A.A.R.
4320, effective January 3, 2009 (Supp. 08-4).
R4-23-1207. Recordkeeping
Title 4 Arizona Administrative Code 4 A.A.C. 23
CHAPTER 23. BOARD OF PHARMACY
March 31, 2020 Supp. 20-1 Page 83
A. Before transferring possession of a prescription medication
donated by an individual or an individual’s health care deci-
sion maker, a medical practitioner, pharmacy, or health care
institution that has possession of the donated prescription med-
ication and through which the donation is being made shall
create an invoice that includes the following:
1. The name and address of the medical practitioner, phar-
macy, or health care institution that has possession of the
donated prescription medication;
2. The name of the individual who made the donation;
3. The brand name or generic name of the prescription med-
ication transferred;
4. If a generic medication, the name of the manufacturer or
the national drug code number of the prescription medi-
cation transferred;
5. The strength of the prescription medication transferred;
6. The quantity of the prescription medication transferred;
7. The lot number of the prescription medication trans-
ferred;
8. The expiration date or beyond-use-date of the prescrip-
tion medication transferred;
9. The date the prescription medication is transferred to a
participating physician’s office, pharmacy, or health care
institution; and
10. The name and address of the participating physician’s
office, pharmacy, or health care institution to which the
donated prescription medication is transferred.
B. Before transferring possession of a prescription medication
donated by a manufacturer, the manufacturer shall create an
invoice that includes the manufacturer’s name and address and
the information described in subsections (A)(3) through (10).
C. Before transferring possession of a prescription medication
donated by a health care institution, the health care institution
shall create an invoice that includes the health care institu-
tion’s name and address and the information described in sub-
sections (A)(3) through (10).
D. A medical practitioner, pharmacy, health care institution, or
manufacturer required to create an invoice under subsection
(A), (B), or (C) shall:
1. Transmit a copy of the invoice and the donor form
required under R4-23-1205 to the participating physi-
cian’s office, pharmacy, or health care institution to
which a donated prescription medication is transferred;
2. Maintain a copy of the invoice for a minimum of three
years from the date of the invoice;
3. Maintain a copy of the donor form for a minimum of
three years from the date signed; and
4. Make a copy of the invoice or donor form available upon
request for inspection by the Board, its designee, or other
authorized officers of the law.
E. A physician’s office, a pharmacy, or a health care institution
that participates in the prescription medication donation pro-
gram shall:
1. Maintain:
a. The documents required under R4-23-1206 for a
minimum of three years from the date signed; and
b. Each invoice and donor form received under subsec-
tion (D)(1) for a minimum of three years from the
date received; and
2. Make the documents required under R4-23-1206 and sub-
section (D)(1) available upon request for inspection by
the Board, its designee, or other authorized officers of the
law.
Historical Note
New Section made by final rulemaking at 14 A.A.R.
4320, effective January 3, 2009 (Supp. 08-4).
R4-23-1208. Handling Fee
A physician’s office, a pharmacy, or a health care institution that
dispenses a donated prescription medication may charge a recipient
of a donated prescription medication a handling fee of no more than
$4.50 per prescription to cover inspection, stocking, and dispensing
costs.
Historical Note
New Section made by final rulemaking at 14 A.A.R.
4320, effective January 3, 2009 (Supp. 08-4).
R4-23-1209. Policies and Procedures
A physician’s office, a pharmacy, or a health care institution that
participates in the prescription medication donation program shall:
1. Develop, implement, and comply with policies and pro-
cedures for the receipt, storage, and distribution of pre-
scription medications donated to the physician’s office,
the pharmacy, or the health care institution;
2. Review biennially and, if necessary, revise the policies
and procedures required under this Section;
3. Document the review required under subsection (2);
4. Assemble the policies and procedures as a written manual
or in a readily accessible electronic format;
5. Make the policies and procedures available for reference
by a physician’s office, pharmacy, or health care institu-
tion personnel and, upon request, for inspection by the
Board or its designee; and
6. Ensure that the written or electronic policies and proce-
dures required under subsection (1) include provisions to
ensure:
a. That each transferred prescription medication meets
the eligibility requirements of Sections R4-23-1202
and R4-23-1203;
b. That each individual who receives a donated pre-
scription medication under the prescription medica-
tion donation program signs the recipient form
specified in R4-23-1206;
c. Compliance with the applicable requirements for
recordkeeping in Section R4-23-1207;
d. Compliance with the requirements of Section R4-
23-1210; and
e. Compliance with the requirements of Section R4-
23-1211.
Historical Note
New Section made by final rulemaking at 14 A.A.R.
4320, effective January 3, 2009 (Supp. 08-4).
R4-23-1210. Dispensing Donated Prescription Medications
A. Before dispensing a donated prescription medication under the
program, a participating physician’s office, pharmacy, or
health care institution shall:
1. Obtain and maintain a current drug identification refer-
ence or text in hard-copy or electronic media format;
2. Inspect the donated prescription medication to ensure that
the prescription medication has not been adulterated;
3. Certify that the donated prescription medication has been
stored in compliance with the requirements of the manu-
facturer’s package insert;
4. Comply with all federal and state laws regarding storage
and distribution of a donated prescription medication;
5. Obtain a prescription order of a licensed medical practi-
tioner for the recipient to receive the donated prescription
medication; and
6. Properly label the donated prescription medication to be
dispensed.
4 A.A.C. 23 Arizona Administrative Code Title 4
CHAPTER 23. BOARD OF PHARMACY
Page 84 Supp. 20-1 March 31, 2020
B. As specified in subsection (C) a participating physician’s
office, pharmacy, or health care institution may transfer a pre-
scription medication donated under this Article to another par-
ticipating physician’s office, pharmacy, or health care
institution, but the donated prescription medication shall not
be resold.
C. A participating physician’s office, pharmacy, or health care
institution may transfer a donated prescription medication to
another participating physician’s office, pharmacy, or health
care institution, if:
1. The transferring physician’s office, pharmacy, or health
care institution has available a prescription medication
that the receiving physician’s office, pharmacy, or health
care institution needs;
2. The transferring physician’s office, pharmacy, or health
care institution prepares an invoice that includes its name
and address and the information described in R4-23-
1207(B)(3) through (10);
3. A copy of the invoice required in subsection (C)(2) is sent
to the receiving physician’s office, pharmacy, or health
care institution with the transferred prescription medica-
tion; and
4. The transferring physician’s office, pharmacy, or health
care institution and the receiving physician’s office, phar-
macy, or health care institution each:
a. Keep a copy of the invoice required in subsection
(C)(2) on file for three years from the date of trans-
fer; and
b. Make the invoice records available, upon request,
for inspection by the Board or its designee.
Historical Note
New Section made by final rulemaking at 14 A.A.R.
4320, effective January 3, 2009 (Supp. 08-4).
R4-23-1211. Responsibilities of the Physician-in-charge or
Pharmacist-in-charge of a Participating Physician’s Office,
Pharmacy, or Health Care Institution
The physician-in-charge of a participating physician’s office; the
pharmacist-in-charge of a participating pharmacy; or the physician-
in-charge or pharmacist-in-charge of dispensing for a participating
health care institution shall, either personally or through a designee:
1. Coordinate the receipt of prescription medications
donated by manufacturers or health care institutions or
through medical practitioners, pharmacies, or health care
institutions from eligible donors;
2. Check each donated prescription medication against the
invoice and any additional alternate record and resolve
any discrepancies;
3. Store and secure donated prescription medications as
required by federal and state law;
4. Inspect each donated prescription medication for adulter-
ation;
5. Certify that each donated prescription medication has
been stored in compliance with the manufacturer’s pack-
age insert;
6. Ensure that expired, adulterated, or unidentifiable
donated prescription medication is not dispensed;
7. Ensure that prescription medications identified under
subsection (6) are destroyed within 30 days of identifica-
tion as specified in subsection (9);
8. Ensure safety in drug recalls by destroying any donated
prescription medication that may be subject to recall if its
lot number cannot exclude it from recall;
9. Ensure destruction of expired, adulterated, unidentifiable,
and recalled donated prescription medication by:
a. Following federal, state, and local guidelines for
drug destruction;
b. Creating a list of expired, adulterated, unidentifi-
able, or recalled donated prescription medications to
be destroyed;
c. Following the destruction, signing the list described
in subsection (9)(b) and having the list signed by a
witness verifying the destruction; and
d. Keeping the list described in subsection (9)(b) on
file for three years from the date of destruction;
10. Redact or remove all previous patient or pharmacy label-
ing on a donated prescription medication before dispens-
ing the donated prescription medication;
11. Ensure that all dispensed donated prescription medica-
tions comply with the labeling requirements of A.R.S. §
32-1968(D);
12. Place on the label of each dispensed donated prescription
medication a beyond-use-date that does not exceed the
beyond-use-date or expiration date from the original label
of the donated prescription medication or, if the dis-
pensed donated prescription medication comes from mul-
tiple packages, the earliest beyond-use-date or expiration
date from the donated prescription medication packages;
and
13. Maintain the records required in this Article.
Historical Note
New Section made by final rulemaking at 14 A.A.R.
4320, effective January 3, 2009 (Supp. 08-4).
