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.
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