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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