TN Vol. 22, No. 3 Page 1
Board Approves Extension of the
Following Waivers
Rule 1140-03-.01(1): Face-to-Face Counseling
Requirement
In order to reduce exposure and transmission of the
coronavirus disease 2019 (COVID-19), eective immediately
the Tennessee Board of Pharmacy has waived the requirement
for patients to be counseled face to face, as stated in Rule
1140-03-.01(1). Counseling may be provided by a pharmacist
by telephone or by other forms of technology or by alternative
means. This waiver does not remove the requirement to
counsel the patient; all eorts should be made to counsel a
patient as before and should cover all aspects of counseling
required in the rule. This waiver will remain in eect through
the end of 2020 unless the Board extends it.
Rule 1140-14-.12(2)(a): Stocking of ADMs in
Long-Term Care Sites
In order to reduce the risk of exposure of patients in long-
term care sites to COVID-19 with incursion of outside person-
nel, eective immediately the Board waives the requirement
that lling/stocking of all medications in the automated
dispensing system shall be completed by a pharmacist or
pharmacy technician under the direct supervision of a phar-
macist. The pharmacist-in-charge shall designate personnel
on site who have sucient training and shall be responsible
for stocking the machines with the medications delivered by
the pharmacy to the site. This waiver will remain in eect
through the end of 2020 unless the Board extends it.
Board Extends Funding to TPRN Program
At its May 5, 2020 meeting, the Board voted to continue
to fund the Tennessee Pharmacy Recovery Network (TPRN)
with a grant of $180,500 for another year. TPRN Program
Director Baeteena Black was appreciative, stating “The
advocates, who are all volunteers, and I appreciate and thank
the Board for its condence in and collaboration with TPRN
for the work done by the program in protecting public safety
and restoring pharmacy professionals to health and practice.”
Black explained that since the mid-1980s, the TPRN
program, working with the members of the TPRN Program
Advocacy Committee, has provided a comprehensive peer
assistance program consisting of assessment, referral for
treatment, monitoring, and advocacy services for pharmacy
professionals and student pharmacists needing assistance
due to substance use disorder, including abuse of alcohol.
She indicated that in September 2017, the TPRN program
entered into a three-year grant contract with the state of
Tennessee to provide the Board with a formalized program
of peer assistance and rehabilitation of impaired pharmacy
professionals licensed or registered in Tennessee. Black
explained that under these provisions, TPRN has provided
peer assistance to pharmacists, pharmacy technicians, and
student pharmacists since that time.
If you need help or know an associate (pharmacist or
pharmacy technician) who does, please contact Dr Baeteena
Black, TPRN program director, by phone at 615/256-3023
(including the reporting form) is located at the following
website.
COVID-19 Spanish Language Resource
Web Page Now Available
The Tennessee Department of Health (TDH) and Unied
Command Group are providing additional COVID-19
materials and resources for Spanish-speaking Tennesseans
through this link. This new web page includes videos, fact
sheets, infographics, and other resources about COVID-19
testing; the Tennessee Pledge; and how to protect yourself,
your family, your coworkers, and your community from
COVID-19. Please click here to view the TDH news release
in its entirety.
TDEC Consultant Explains Waste Disposal
(Part III)
By Benjamin Almassi, Tennessee Department of Environment
and Conservation (TDEC) Environmental Consultant 1
From IV prep, general compounding, spills, and expired
drugs, to packaging and partially used vials, there is a
continued on page 4
665 Mainstream Drive • Nashville, TN 37243
https://www.tn.gov/health/health-program-areas/health-professional-boards/pharmacy-board.html
September 2020
Published to promote compliance of pharmacy and drug law
News
Tennessee
Board of Pharmacy
help promote quality compounding practices and better
address emerging public health concerns that may affect
patients.”
FDA Clarifies Compounding Rules,
Offers Flexibility to Help Ease Drug
Shortages During COVID-19 Pandemic
FDA noted it will use discretion in enforcing certain
standards related to 503A and 503B compounding in
an effort to ease drug shortages during the coronavirus
disease 2019 (COVID-19) pandemic. During an
American Pharmacists Association (APhA) webinar on
April 30, 2020, the agency clarified it will “look to 503B
compounders to grapple with drug shortages” and “turn
to 503A compounders to fill in the gaps.”
In addition, the agency clarified that medications on
the FDA drug shortage list are effectively considered “not
commercially available,” which frees 503A and 503B
compounding facilities from limits on compounding
drugs that are “essentially a copy” of a product already
available on the market. FDA also does not intend to take
action if a 503A facility fills orders for a compounded
drug that is essentially a copy of an approved drug that
has been discontinued and is no longer marketed.
In April 2020, FDA issued a temporary guidance that
granted flexibility for pharmacists to compound certain
necessary medications under 503A for nonspecific
patients hospitalized due to COVID-19. In addition, a
temporary guidance was issued that granted enforcement
flexibility for 503B outsourcing compounding facilities
for drugs in shortage for patients hospitalized during
the COVID-19 public health emergency. The guidance
documents stipulate the conditions compounders
must meet and are available at https://www.fda.gov/
media/137125/download.
More information on these compounding rule
clarifications is available in a May 5, 2020 press release
on the APhA website.
CMS Allows Pharmacies to Temporarily
Enroll as Clinical Diagnostic
Laboratories for COVID-19 Testing
Centers for Medicare & Medicaid Services (CMS)
has released a document detailing a process that allows
pharmacies to temporarily enroll as independent clinical
diagnostic laboratories. This process will allow those
Page 2
FDA Releases MOU on Human
Drug Compounding Regulation and
Oversight
Acknowledging the vital role states play in reducing
the risks associated with compounded drugs, Food
and Drug Administration (FDA) has made available a
Final Standard Memorandum of Understanding (MOU)
Addressing Certain Distributions of Compounded Human
Drug Products, intended to be entered into between the
agency and the states. The release of the MOU is required
as part of its submission to the Office of Management and
Budget for review and clearance under the Paperwork
Reduction Act of 1995. The MOU was developed in close
consultation with the National Association of Boards of
Pharmacy
®
(NABP
®
), as described in the Federal Food,
Drug, and Cosmetic Act. The agency also engaged with
states, pharmacies, associations, pharmacists, and other
stakeholders.
Among the issues addressed in the MOU is the
definition of the statutory term “inordinate amounts,”
which refers to compounded drugs that are distributed
interstate. In addition, the MOU includes the risk-based
oversight model from the 2018 revised draft MOU.
States that sign the document agree to identify pharmacy
compounders that distribute inordinate amounts (greater
than 50%) of compounded drug products interstate, as
well as report certain information to FDA about those
compounders. FDA also provided clarity in the MOU
on state investigations of complaints associated with
compounded drugs distributed out of state. States that
enter into the MOU will investigate complaints about
drugs compounded at a pharmacy within their state and
distributed outside of the state and advise FDA when they
receive reports of serious adverse drug experiences or
serious product quality issues, like drug contamination.
To help states to better investigate these issues, FDA
has also announced an agreement with NABP to make
an information sharing network available to the states.
Through this network, states will be able to obtain infor-
mation from pharmacies in their states and transmit that
information to FDA.
“We anticipate the final MOU, once signed, will help
to facilitate increased collaboration between the FDA
and the states that sign it,” said Janet Woodcock, MD,
Director, Center for Drug Evaluation and Research,
in an FDA Voices article. “Working together, we can
National Pharmacy Compliance News
September 2020
The applicability of articles in the National Pharmacy Compliance News to a
particular state or jurisdiction can only be ascertained by examining the law of
such state or jurisdiction.
National Association of Boards
of Pharmacy Foundation
NABPF
FOUNDATION
Page 3
facilities to seek Medicare reimbursement for COVID-19
tests, making it easier for them to provide that service
during the pandemic.
“Up until this point in time, most pharmacies could
only offer this as a cash service because they were not
considered providers through CMS, and really a lot of
the third-party payers really didn’t have an interest in a
fee-for-service type model,” said Michael E. Klepser,
PharmD, FCCP, pharmacy professor at Ferris State
University, in an interview with Bloomberg Law. “The
fact that CMS is saying we’re now authorizing or
allowing pharmacists to get reimbursed for these is a
great door opening at the federal level and that’s a huge,
huge thing.”
Chain pharmacies such as CVS, Walgreens, and Rite
Aid are offering drive-through testing at many pharmacies
throughout the country.
FDA Issues Updated Guidance
for Compounding Pharmacies
Experiencing PPE Shortages
FDA has issued an update for its guidance to pharmacy
compounders that may experience shortages of personal
protective equipment (PPE) during the COVID-19
pandemic. As compounders typically utilize PPE when
performing sterile compounding, the updated guidance
clarifies that the drugs can be compounded under the
policy in a segregated compounding area that is not in
a cleanroom. This policy has been adopted to ensure
patients continue to have access to medicines they
need during the pandemic, and to reduce the risks of
compounding when standard PPE is not available.
In addition to FDA guidance, United States Pharmaco-
peial Convention has previously issued an informational
document for compounders regarding garb and PPE short-
ages during the pandemic. The document includes recom-
mendations for conserving garb and PPE and what steps
might be considered in the case of shortages of garb and
PPE used for both sterile and nonsterile compounding.
The updated guidance can be accessed through
FDA’s website by visiting www.fda.gov/media/136841/
download.
HHS Expands Telehealth Access in
Response to COVID-19
In an effort to prevent and respond to the COVID-19
pandemic, the US Department of Health and Human
Services (HHS) has awarded $20 million to increase
telehealth access and infrastructure for health care
providers and families. The funds, which are awarded
through the Health Resources and Services Administration
(HRSA), will increase capability; capacity and access
to telehealth and distant care services for providers,
pregnant women, children, adolescents, and families;
and assist telehealth providers with cross-state licensure.
“This new funding will help expand telehealth
infrastructure that is already being used during the
pandemic to provide essential care, especially to the most
vulnerable, including pregnant women and children with
special health care needs,” said HHS Secretary Alex Azar
in a press release. “This funding will also help clinicians
use telehealth nationally by streamlining the process to
obtain multi-state licensure.”
HRSA’s Maternal and Child Health Bureau awarded
a total of $15 million to four recipients; each award sup-
ports a key area in maternal and child health, including
pediatric care, maternal health care, state public health
systems, and family engagement for children with special
health care needs. HRSA’s Federal Office of Rural Health
Policy awarded a total of $5 million to two recipients
through the Licensure Portability Grant Program, which
will assist telehealth clinicians nationally on licensure
and credentialing to meet emerging needs related to
COVID-19.
Criminals Found Posing as CDC
Representatives to Steal Money and
Information
Centers for Disease Control and Prevention (CDC)
is warning the general public of a new type of phone
and phishing scam by criminals posing as CDC
representatives, often requesting donations. According
to CDC, most of these fraudulent activities are being
conducted by phone, utilizing software to “spoof” phone
calls to make them appear as if they are coming from
phone numbers that may look familiar. CDC advises
consumers to avoid answering calls from numbers they do
not recognize, and to avoid sharing personal information
over the phone. In addition, CDC notes that no federal
agency will request donations from the general public.
Suspicious phone calls may be reported to the Federal
Communications Commission.
More information on the scams is available on the CDC
website at https://www.cdc.gov/media/phishing.html.
National Pharmacy Compliance News
September 2020
Page 4
vast variety of activities overseen by multiple regulatory
bodies, including the state boards, the Department of
Transportation, the Occupational Safety and Health
Administration, Drug Enforcement Administration (DEA),
and the Environmental Protection Agency (EPA). Of the
2,000-4,000 drugs stocked in typical hospital pharmacies,
approximately 4-5% are subject to EPA hazardous waste
(HW) regulations through the Resource Conservation and
Recovery Act (RCRA). These HW pharmaceuticals are now
banned from all sewering. EPA places the burden of proof
for making an HW determination on the generator (eg,
pharmacy). This action could be performed independently
or with a third party, which would make the process easier
and streamlined. Compliance assessments get tricky when
considering non-regulated pharmaceutical wastes such as
chemotherapeutic agents, drugs meeting National Institute
for Occupational Safety and Health/Occupational Safety
and Health Administration Hazardous Drug Criteria for
safe handling, and endocrine disruptors. Some fall within
RCRA as HW pharmaceuticals. As an example, only nine
chemotherapy drugs are either P- or U-listed HW chemicals.
What does this mean? In future articles, when COVID-19
is behind us, an in-depth look will be provided along with
other regulatory nuances (such as sole active ingredients and
empty containers). For now, let us establish a framework:
HWs are divided into two categories: listed wastes and
characteristic wastes. Listed wastes appear on one of four
lists of HW (F, K, P, and U). HW pharmaceuticals found on
two of these lists, P and U, contain commercial chemical
products. P-listed wastes are chemicals rst and therapeutic
agents second. A primary criterion for a P-listed drug is an
oral lethal dose of 50 mg/kg (LD50) or less. These include
epinephrine (P042, but not salts), warfarin >0.3% (P0081),
and phentermine CIV (P046, it is best to use the CAS#).
Chemicals are U-listed primarily for toxicity. These include
lindane (U129) and mercury (U150, eg, thimerosal). To
be P or U listed, the drug waste must contain a sole active
ingredient (not ancillary functioning as a mobilizing or
preserving agent) on the P or U list, and it must not have
been used for its intended purpose. Characteristic wastes
are regulated because they exhibit certain properties –
ignitability (D001, eg, erythromycin gel 2%), corrosivity
(D002, strong acids/bases), reactivity (D003, rare), and
toxicity (D004-D043, eg, barium sulfate). The details of
each of these properties can be explored with TDEC’s online
determination matrix.
A future article will cover guidance on managing combi-
nations of HW, contaminated personal protective equipment,
and best management practices.
DEA Gives Additional Guidance on
Proper Filing of Old Triplicate Form 222
vs New Single-Sheet Form 222 When the
Registrant Pharmacy Is the Supplier
According to DEA Nashville District Oce Diversion
Group, some registrants are sending DEA Form 222s to the
incorrect locations. Be advised that the new DEA Form 222
single forms are to be scanned and emailed to the address
located in the upper right corner of DEA Form 222 (dea
[email protected]) when the pharmacy is considered
the supplier. The investigator indicated that these new DEA
Form 222 copies are not to be sent to the local DEA oces
and that the scan/email is the preferred option, but understands
that some pharmacies do not have that capability at this time.
For those pharmacies that lack the technology to scan/email,
regular mailing to the following address is acceptable: Drug
Enforcement Administration, Attn: Registration Section/
However, the investigator noted that one form that is
Do you have additional questions? Contact a DEA diversion
investigator:
♦ Diversion Group Supervisor
Jacqueline Jordan
571/362-2274; [email protected]
50 North Front Street, Memphis, TN 38103
♦ Diversion Group Supervisor
James Stevens
571/362-7674; [email protected]
801 Broadway Suite 500, Nashville, TN 37203
♦ Diversion Group Supervisor
Mark Armstrong, II
865/584-9364; [email protected]
624 Reliability Circle, Knoxville, TN 37932
Board Meeting Schedule
The Board extends an open invitation for all registrants
and the general public to attend its public meetings at 665
Mainstream Drive, Nashville, TN 37243. The meetings are
currently scheduled to begin at 8 . Pharmacists may receive
up to two hours of live continuing education, valid for their
Tennessee pharmacist license on a full meeting day, and one
hour on a half day. Because of COVID-19, past meetings
have been conducted using WebEx on the rst day instead
of the two days listed. Therefore, it is advised to check for
Tennessee Board of Pharmacy News
September 2020
continued from page 1
continued on page 5
schedule changes on the Board website under the Meeting
Schedule tab.
The 2020 meeting schedule is as follows:
♦ September 15-16
♦ December 1-2
The meeting schedule is as follows:
♦ January 26-27
♦ March 9-10
♦ May 4-5
♦ July 13-14
♦ September 14-15
♦ November 16-17
Tennessee Board of Pharmacy Members
♦ Dr Rissa Pryse – President
♦ Dr Katy Wright – Vice President
♦ Dr Adam Rodgers – Board Member
♦ Dr Melissa McCall – Board Member
♦ Dr Richard Breeden – Board Member
♦ Dr Debra Wilson – Board Member
♦ To Be Announced – Board Member
♦ To Be Announced – Public Member
continued from page 4
Tennessee Board of Pharmacy News
September 2020
continued on page 5
Page 5 – September 2020
The Tennessee Board of Pharmacy News is published by the Tennessee Board
of Pharmacy and the National Association of Boards of Pharmacy Foundation
®
(NABPF
®
) to promote compliance of pharmacy and drug law. The opinions and views
expressed in this publication do not necessarily reect the ocial views, opinions,
or policies of NABPF or the Board unless expressly so stated.
Rissa Pryse, DPh - Tennessee Board of Pharmacy President
& Newsletter Editor
Reggie Dilliard, DPh - Executive Director & Newsletter Editor
Scott G. Denaburg, PharmD, DPh, CISCI - Contributor &
Tennessee Board of Pharmacy Investigator
Lemrey “Al” Carter, PharmD, MS, RPh - National News Editor & Executive
Editor
Amy Sanchez - Communications Manager
