FDA Issues Draft Enforcement Guidance on Compounding Animal Drugs From Bulk Substances

November 21, 2019

On Nov. 19, the U.S. Food and Drug Administration (FDA) released draft guidance for industry members regarding compounding animal drugs from bulk substances.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 FDA is accepting comments on this draft guidance until Feb. 18, 2020.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FDA has historically exercised enforcement discretion when it comes to compounding animal drugs, and the draft guidance clarifies the circumstances under which FDA intends to continue this practice.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 circumstances:

  • compounding pursuant to patient-specific prescriptions for non-food-producing animals;
  • 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 consult the author or another member of the McGuireWoods life sciences team.