FDA Policy/General

Animal Drug Compounding Guidance

FDA has published a final guidance, Compounding Animal Drugs from Bulk Drug Substances, describing the agency’s enforcement policy for the compounding of animal drugs from bulk substances by or under the direction of veterinarians or pharmacists. The document does not apply to animal drugs compounded for use in investigations of new animal drugs or to animal drugs compounded from FDA-approved animal or human drugs, which are considered legal extra-label uses of such drugs.

The guidance says it continues to be FDA’s practice to balance concerns about the risks of animal drugs compounded from bulk drug substances, which have not gone through agency premarket review, with the need for such drugs when no FDA-approved or indexed drug is medically appropriate to treat the animal.

“At this time and based on our understanding of the risks of animal drugs compounded from bulk drug substances, FDA generally does not intend to take enforcement action for violations of the Federal Food, Drug, and Cosmetic Act’s requirements for approval, adequate directions for use, and current good manufacturing practice for compounding of products under the circumstances below,” the guidance says. It adds that the policies are also intended to focus FDA’s enforcement activities on animal drugs compounded from bulk drug substances that present the most significant concerns, including compounded drugs that:

present particular human or animal safety concerns;
are intended for use in food-producing animals;
are copies of marketed FDA-approved or indexed drugs; or
are compounded without a patient-specific prescription (i.e., office stock).

“FDA will make enforcement decisions on a case-by-case basis, recognizing that it needs to make the best use of limited agency resources,” the guidance says.

The document finalizes a 2019 draft guidance that received significant changes based on comments from veterinarians, pharmacy compounders, and other stakeholders, FDA says in a statement.

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