On Nov. 19, the U.S. Food and Drug Administration (FDA) released draft guidance for
industry members regarding compounding animal drugs from bulk substances.
The guidance is intended for veterinarians and pharmacists in either
state-licensed facilities or federal facilities and outlines the agency’s
enforcement policy regarding the use of compounded animal drugs in
violation of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
FDA is accepting comments on this draft guidance until Feb. 18, 2020.
The guidance applies only to drugs compounded from bulk substances,
excluding circumstances where animal drugs are compounded from FDA-approved
drugs for animal or human use (which FDA considers extralabel uses of such
drugs). Furthermore, although there are numerous FDA-approved or
conditionally approved drugs for animal use, FDA recognizes that there are
numerous species, each with unique conditions and needs, for which no
approved treatment is available. Therefore, FDA recognizes that there are
circumstances in which compounding drugs from bulk substances may be
medically appropriate. Nevertheless, FDA clarified that it will take action
when animal drugs compounded from bulk drug substances (1) present
particular human or animal safety concerns, or (2) do not meet other
manufacturing, product quality, labeling or packaging requirements of the
FD&C Act (e.g., if the product is made under unsanitary conditions or
the labeling is false or misleading).
FDA has historically exercised enforcement discretion when it comes to
compounding animal drugs, and the draft guidance clarifies the
circumstances under which FDA intends to continue this practice. The
guidance addresses the specific requirements for the following three
compounding pursuant to patient-specific prescriptions for
compounding without patient-specific prescriptions (i.e., office stock)
for non-food-producing animals; and
compounding drugs for use as antidotes for food-producing animals.
In addition to the specific requirements for the above circumstances, the
guidance clarifies that FDA generally intends to exercise enforcement
discretion primarily in circumstances in which a veterinarian is acting
within a valid veterinarian client-patient relationship and where no other
medically appropriate drug is available — i.e., when there is no medically
appropriate drug that is FDA-approved, conditionally approved or on the
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
(indexed) to treat the animal.
FDA expressed “significant concern,” however, about circumstances where
compounded animal drugs present particular human or animal safety concerns;
are intended for use in food-producing animals; are copies of marketed
FDA-approved, conditionally approved or indexed drugs; or are compounded
without a patient-specific prescription (i.e., office stock).
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Practitioners should review the draft guidance carefully to ensure that
their current practices comply with FDA’s expectations and avoid the
specific safety concerns raised by FDA. FDA clarified that when pharmacies
and veterinarians compound animal drugs from bulk substances consistent
with the draft guidance, FDA intends to generally defer to state licensing
boards for day-to-day oversight. For questions regarding compounding animal
drugs or for assistance submitting a comment on the draft guidance, please
author or another member of the
McGuireWoods life sciences team.