Compounding from unapproved (bulk) substances in food animals

Compounding of drugs from unapproved (bulk) substances for use in animals is currently illegal under the Federal Food, Drug, and Cosmetic Act and the Animal Medicinal Drug Use Clarification Act. Unapproved bulk substances are the raw active pharmaceutical ingredients (APIs) that are used to make final drug products, and as such, they are not commercially available as FDA-approved finished drug products. Veterinarians cannot guarantee the potency, purity, or safety of these unapproved bulk substances in a compounded product. The AVMA recognizes specific circumstances wherein bulk compounds might be medically necessary in food animals, specifically poison antidotes and compounds for euthanasia or depopulation that are not approved or commercially available. These actions should take place only within the context of a veterinarian-client-patient relationship. The AVMA recommends that there be a publically available, current list of unapproved bulk substances that can be legally compounded within a veterinarian-client-patient relationship specific and limited to euthanasia, depopulation, and poison antidote compounds, for food animal species. If adequate scientific information is not available to determine a withdrawal time, the compound cannot be used in a food animal or the treated animal cannot enter the food supply.

Additional resources:

Compounding: Are you playing by the rules?

Related policies: