AAWV Survey on FDA Draft Guidance for Compounding Animal Drugs from Bulk Drug Substances



The American Association of Wildlife Veterinarians (AAWV) is surveying wildlife veterinarians who order and administer drugs that are compounded from bulk drug substances to wildlife species. The intent of the survey is threefold: (1) to gather information about which bulk compounded drugs wildlife veterinarians use, the frequency and purpose behind their use, and the species to which they are administered; (2) to catalog where wildlife veterinarians order bulk compounded drugs from; and (3) to determine how draft FDA guidance may impact wildlife veterinarians’ reliance on bulk compounded drugs.

A bulk compounded drug is a pharmaceutical that is derived from bulk drug substances or raw active ingredients. It is not to be confused with standard drug compounding which involves the manipulation of an FDA-approved drug into a preferred form (e.g., creating an oral suspension from crushed tablets, diluting the concentration of an injectable solution, mixing two or more injectable solutions).

The FDA draft guidance, if finalized, would advise veterinarians on circumstances under which the FDA does not intend to take action for certain violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) when pharmacists and veterinarians compound or oversee the compounding of animal drugs from bulk drug substances. Circumstances in which the FDA will forego enforcement include the preparation, prescription, and administration of bulk compounded drugs for a specific individual or a group of non food-producing animals, for office stock for non food-producing animals if the drug is on the FDA’s list of approved drugs, and for food-producing animals if the drug is on the FDA’s list of approved drugs and only if used as an “antidote for treating toxicosis”.

Pharmacies and veterinarians may therefore be held liable when dealing with unapproved bulk compounded drugs for office stock for non food-producing animals, unapproved bulk compounded drugs for food-producing animals, and even approved bulk compounded drugs for food-producing animals if not used as an antidote against a toxin. With many wildlife species available for harvest and thereby considered food-producing animals, such guidance would dramatically limit the availability of bulk compounded drugs to wildlife veterinarians.

For more background information: https://www.fda.gov/animal-veterinary/cvm-updates/fda-releases-revised-draft-guidance-compounding-animal-drugs-bulk-drug-substances.

For the draft guidance document: https://www.fda.gov/media/132567/download.

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