Innovations-Magazine-June-2023 - 5
POLICY PERSPECTIVES
When compounding a copy of an animal
drug, the pharmacist should maintain a
record of the medical rationale describing
the clinical difference. FDA does not intend
to question prescriber determinations
that are documented in a prescription or
notation. The agency does intend to consider
whether a prescription or notation relied
upon by a compounder documents that
the determination was made and includes
a medical rationale describing the clinical
difference. The guidance provides several
examples of acceptable and unacceptable
medical rationales.
The final guidance also addresses FDA's
main concerns about compounding of animal
drugs from bulk drug substances, including
concerns with these drugs when they:
* present human or animal safety concerns;
* are for use in food-producing animals;
* are copies of a marketed FDA-approved
or indexed drug; and
* are compounded without a patientspecific
prescription and sold to
veterinarians as office stock.
With the issuance of the final guidance,
FDA established a public docket so that
interested parties could nominate bulk drug
substances to be included on a list of bulk
drug substances for compounding office
stock drugs for use in nonfood-producing
animals or antidotes for food-producing
animals, and to comment on the nominated
and evaluated bulk drug substances. In
addition to issuing the final guidance,
FDA expanded the request for nominations
to include drugs compounded for use as
sedatives or anesthetics for free-ranging
wildlife species. Interested parties can now
nominate bulk drug substances for inclusion
on the following lists:
* the List of Bulk Drug Substances for
Compounding Office Stock Drugs for
Use in Nonfood-Producing Animals; and
* the List of Bulk Drug Substances
for Compounding Drugs for Use
in Food-Producing Animals or
Free-Ranging Wildlife Species.
Reliance on State Licensing Boards
The final guidance explains that FDA will
rely on compounding pharmacies' home
state licensing boards to provide day-to-day
oversight of routine compounding practices,
but that FDA may provide concurrent
oversight of compounding practices when
considered appropriate. Should FDA have
cause for concern, the agency indicated it
may also refer the matter to the appropriate
state licensing board.
At press time, several states are in the
process of introducing legislation or regulations
in connection with veterinary compounding.
In January 2023, in New York, the bill NY
S 2314 was introduced to the Committee on
Higher Education. The bill would authorize
a pharmacist to dispense drugs, including
veterinary-specific compounded medications,
to a veterinarian; and a veterinarian may keep
those compounded medications in stock for
administration and sale pursuant to a non-patientspecific
regimen prescribed or ordered by any
licensed veterinarian, provided, however, that
any dispensing of drugs containing controlled
substances (CS) will be subject to New York State
Department of Health limitations.
Also introduced in 2023 was Oregon
Senate Bill 559, which requires veterinarians
to participate in Oregon's prescription
monitoring program (PMP). In addition, it
requires the Oregon State Veterinary Medical
Examining Board to provide the Oregon
Health Authority with information of
licensed individuals authorized to prescribe
or dispense CS to be used to qualify the
licensee to report information about or
receive information from the PMP.
Georgia legislators introduced a proposed
amendment to its compounded drug
regulations under GA ADC 480-11-.02(1)
(d)(1) expanding the length of time, from
four to 10 days, for which a compounded
prescription may be dispensed for use in
veterinary emergencies.
Effect of USP Compounding Chapters
United States Pharmacopeia (USP), which
sets pharmaceutical standards that apply to
both human and veterinary medicine, has
released its final revisions to USP General
Chapters <795> and <797> on pharmaceutical
compounding of nonsterile and sterile
preparations, respectively. These chapters will
become official on November 1, 2023, and
although USP is not a regulatory body and
does not enforce its standards, these chapters
will likely affect veterinarians should USP's
standards be incorporated or referenced in laws
affecting the locale in which they practice.
Emphasis on Factfinding
It remains to be seen how FDA will use the
final guidance to enforce restrictions on
animal drug compounding. FDA has stated
that it " will continue to engage stakeholders
to address questions and clarify certain aspects
of the guidance " as the agency undertakes
routine inspection activities. The agency's
initial emphasis for these inspectional activities
will be to gather facts about compounding
operations as they relate to the final guidance
and discuss them with the inspected pharmacy
or facility. Information obtained during
animal drug compounding inspections will
be evaluated in accordance with FDA's prior
notice policy. Through September 2023, FDA
intends to conduct only a limited number of
inspections at state-licensed pharmacies.
FDA has stated that it does not intend
to conduct routine inspections relating to
the enforcement priorities for animal drugs
described in the final guidance. However, the
agency did emphasize that it may conduct
nonroutine inspections at outsourcing facilities
related to animal drugs if there are concerns
with animal drugs compounded by these
facilities that may present human or animal
safety concerns. For now, it appears animal
drug compounding is not an enforcement
priority for FDA, especially if there is a lack of
safety concerns by the agency.
This article was written by Jonathan A.
Keller, PharmD, JD, RPh, and Winnie R.
McBride, JD, with Faegre Drinker Biddle
& Reath LLP. Please note, the opinions and
views expressed by Faegre Drinker Biddle &
Reath do not necessarily reflect the official views,
opinions, or policies of NABP or any member
board unless expressly stated.
JUNE 2023 | 3
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