Compounding Animal Drugs From Bulk Ingredients

Recent public discussion about the federal role in regulating compounding pharmacies has focused on compounded drugs for human use. Compounded drugs are also vital to companion animal health (like pets). 1 In the world of animal compounding, the legality of compounding animal drugs from bulk ingredients, alongside the U.S. Food and Drug Administration's (FDA) power to enjoin compounding from bulk, has been hotly debated. As set forth below in this Alert, nothing in the Federal Food, Drug, and Cosmetic Act (FDCA), its accompanying regulations or the case law declares compounding animal drugs from bulk ingredients illegal.

The FDCA does not contain a provision that regulates compounding of animal drugs. The Animal Medicinal Drug Use Clarification Act (AMDUCA), 2 which was passed in 1994, does not regulate animal compounding. AMDUCA allowed a veterinarian to prescribe an approved human or animal drug for off-label use. AMDUCA was enacted to expand the availability of medication to animals. Under earlier FDCA provisions, a drug was deemed unsafe unless it was used exactly as indicated on the label, meaning the drug had to be used for the specific species and disease—and in the specified dose and delivery format. To give animals better access to medication, AMDUCA allowed conditions under which the veterinarians could use approved animal and human drugs for different conditions on different species outside of what was specified on the label.

Although Congress did not grant FDA authority over animal compounding via AMDUCA, FDA promulgated a regulation under AMDUCA entitled "[e]xtra label use from compounding of approved new animal and approved human drugs."3 FDA authority to enact such a regulation is questionable, as AMDUCA did not give FDA authority to regulate compounding of animal drugs. Nevertheless, the language of the regulation does not seem to lead to the conclusion that compounding from bulk drugs is illegal. The regulation applies to "compounding of a product from approved animal or human drugs," so "[n]othing in this part shall be construed as permitting compounding from bulk drugs."4 This means that the regulation addresses compounding only from approved products; the last sentence is simply confirmation that this regulation does not address compounding from bulk drugs.

FDA has agreed that AMDUCA and this regulation do not give FDA the authority to prohibit compounding from bulk ingredients. In United States v. Franck's Lab Inc., the...