13.16. Compounding Animal Drugs: Compounding animal
drugs from bulk drug substances (active pharmaceutical
ingredients) violates the Federal Food, Drug, and Cosmetic
Act (FD&C Act). The FD&C Act does not distinguish
compounding from manufacturing or other processing
of drugs for use in animals, so animal drugs produced by
compounding fall within the FD&C Act’s approval, adulteration,
and misbranding requirements. The only exception
is for drugs compounded from finished, approved human or
animal drug products, which Food and Drug Administration
(FDA) considers a legal extralabel use under the Animal
Medicinal Drug Use Clarification Act of 1994, so long as
the compounding of those drugs meets the extralabel use
requirements in the FD&C Act and FDA regulations in 21
CFR Part 530. Extralabel use does not include compounding
starting with bulk drug substances.
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