Compounding from Unapproved (Bulk) Substances in Non-Food Animals

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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 believes there are three general sets of circumstances in which compounding from bulk pharmaceutical ingredients may be medically necessary: the approved product is not commercially available, the needed compounded preparation cannot be made from the approved product, or there is no approved product from which to compound the needed preparation. The AVMA recognizes that compounding of drugs from unapproved bulk substances for use in animals not intended for food (eg, major and minor non–food animal species) is medically necessary in certain situations and should be allowed in those circumstances as specifically indicated above. These actions should take place only within the context of a veterinarian-client-patient relationship.

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Related Policies:

Compounding from Unapproved (Bulk Substances) in Food Animals