The FDA published a final guidance document on animal drug compounding from bulk drug substances in August 2022. The Center for Veterinary Medicine issued this guidance to serve as a reference for veterinarians, pharmacies, and federal facilities. The process of combining or modifying ingredients to create a composition suitable for an animal’s needs is known as animal drug compounding.

Compounding animal products is legal under the Federal Food, Drug, and Cosmetic Act (FD&C Act) if the active ingredient source is an FDA-approved medication. Compounds derived from bulk drug substances are not FDA approved, so their safety and efficacy have not been evaluated. A bulk drug substance becomes the active ingredient upon compounding the final product.

The goals of this guidance are to ensure that veterinarians have access to appropriate drugs for treatment, to protect humans and animals from dangerous drug products, and to maintain the integrity of the animal drug approval process. This document describes the types of drugs made from bulk drug substances that pose the greatest risk to human and animal health, as well as the circumstances under which the FDA will not take enforcement action against drugs made from bulk drug substances. The three main scenarios apply to medications compounded to fill patient-specific prescriptions for nonfood-producing animals, nonfood-producing animal office stock, and food-producing animals.

Compounding for nonfood-producing animals should be done by or under the direct supervision of a veterinarian or state-licensed pharmacist for patient-specific prescriptions. The ingredients used, including the bulk drug substance, must meet the United States Pharmacopeia-National Formulary (USP-NF) monograph standards. The labeling of the compounded product should include information such as the drug’s name and strength, the patient’s species, identification information for the compounding pharmacy and/or veterinarians, the expiration date, and other pertinent statements.

Similarly, compounds made without a prescription for “office stock” must be made by or under the supervision of a veterinarian or a state-licensed pharmacist. The FDA’s list of bulk drug substances should be used (specified in the guidance). In the same practice, the veterinarian who stocks the drug dispenses or transfers it to the owner or caretaker of the animal patient. The labeling of the compounded drug follows the criteria outlined above.

The final circumstance pertains to compounds developed for food-producing animals as antidotes or sedatives/anesthetics for free-roaming wildlife species. As stated in the preceding two instances, these compounds are created by or under the supervision of a veterinarian or a state-licensed pharmacist. The prescribing veterinarian must have a valid client-patient relationship and must ensure that the animal does not enter the food supply chain.

The circumstances identified do not warrant enforcement action for a violation of the FD&C act in the context of compounding animal drugs from bulk drug substances. This updated guidance is intended to serve as a resource for both veterinarians and pharmacists when compounding animal drug formulations.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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