Innovations-Magazine-June-2023 - 4

POLICY PERSPECTIVES
Compounding Animal Drugs: Overview of FDA's Final
Guidance and Recent State Actions
Jonathan A. Keller,
PharmD, JD, RPh,
Faegre Drinker Biddle
& Reath LLP
Winnie R. McBride, JD
Faegre Drinker Biddle
& Reath LLP
Veterinary compounding is regulated by both
Food and Drug Administration (FDA) and
state boards of pharmacy. In recent months,
FDA, as well as several states, have taken
additional steps to regulate compounded
animal drugs. This column explores FDA's
recent final guidance regarding animal drugs
compounded from bulk substances and
discusses recent state laws to regulate the
compounding of animal drugs.
Enforcing Pharmacy Inspections
On April 13, 2022, FDA's Center for
Veterinary Medicine issued the Final Guidance
for Industry No. 256, Compounding Animal
Drugs from Bulk Drug Substances. Even
though FDA issued this guidance a little over
a year ago, the agency delayed enforcement
of it through routine pharmacy inspections
until April 2023. The final guidance sets
forth FDA's enforcement policy regarding
the compounding of animal drugs from
bulk substances by or under the direct
supervision of veterinarians or pharmacists.
FDA says that the final guidance " strikes the
right balance between maintaining access
to drugs veterinarians need to treat diverse
animal populations, while ensuring human
and animal health is protected from poorly
compounded products, or ones that attempt
to copy existing FDA-approved drugs. "
The Federal Food, Drug, and Cosmetic Act
(FD&C Act) requires that animal drugs be
approved, conditionally approved, or indexed
on the Index of Legally Marketed Unapproved
New Animal Drugs for Minor Species by
FDA before they may be legally marketed.
This approval process provides important
protections for humans and animals.
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Additionally, FDA-approved animal drugs
are subject to requirements once such
products are available on the market, including
a reporting obligation of adverse events or
product defects so that FDA may continue to
monitor the safety of the drug after approval.
Like human drug compounding, animal
drug compounding is the process of
combining, mixing, or altering ingredients to
create a medication tailored to the needs of an
individual animal or small group of animals.
Under the FD&C Act, compounding is
allowed when the compounder uses active
ingredients from a finished, FDA-approved
drug. The FDA guidance notes that
extra-label use of compounded animal drugs
made from FDA-approved animal drugs is
permitted, provided that the conditions for
legal extra-label use and FDA's extra-label
use regulations are met.
The FD&C Act does not distinguish
compounding animal drugs from bulk
drug substances, also known as active
pharmaceutical ingredients, from other
drug manufacturing methods, such as those
methods for compounding human drugs.
However, animal drugs compounded from
bulk substances violate the FD&C Act
because these animal drugs do not go through
any premarket review processes to receive an
approval or conditional approval, and they are
not indexed on the Index of Legally Marketed
Unapproved New Animal Drugs for Minor
Species. Further, compounded animal drugs
violate the FD&C Act because they are not
prepared in accordance with current Good
Manufacturing Practice (cGMP) requirements
and do not have adequate directions for use.
Summarizing FDA Policy
Historically, FDA has refrained from taking
enforcement action against animal drugs
compounded from bulk drug substances
under certain circumstances when no other
medically appropriate treatment options exist.
The final guidance continues this practice
while balancing FDA's concerns regarding the
risks of animal drugs compounded from bulk
drug substances that have not gone through
FDA's premarket review, are not subject to
FDA's cGMP requirements, and do not have
adequate directions for use.
The final guidance specifically addresses
compounding from bulk drug substances for:
* patient-specific prescriptions for
nonfood-producing animals;
* office stock for nonfood-producing
animals; and
* antidotes for food-producing animals
and sedatives and anesthetics for
free-ranging wildlife species.
The final guidance discusses the
circumstances under which FDA will
generally not take enforcement action
for compounded animal drugs for the
above-referenced purposes. The
circumstances vary based on the purpose
for which the animal drug is compounded;
however, these circumstances include that:
* the compounding is by or under the
direct supervision of a veterinarian or a
pharmacist in a state-licensed pharmacy
or federal facility;
* the drug is compounded in compliance with
state laws and regulations governing drugs
and pharmacy and veterinary medicine;
* the compounder labels the compounded
drug with certain information; and
* upon becoming aware of any adverse
event or product defect, the compounder
reports the event on Form FDA 1932a
within 15 business days.
FDA further clarified that for
compounding patient-specific prescriptions
for nonfood-producing animals, the drug
must not be a copy of a marketed FDAapproved
or indexed animal drug. If it is a
copy, there must be a difference between the
compounded drug and the FDA-approved
or indexed drug that will produce a clinical
difference in the patient as determined by
the treating veterinarian. FDA considers a
compounded drug a copy if it has the same
active ingredient or active moiety and can be
given by the same route of administration as
a marketed FDA-approved or indexed drug.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-256-compounding-animal-drugs-bulk-drug-substances
Innovations-Magazine-June-2023

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