Compounding Animal Drugs from Bulk Ingredients: Legal Review

"Nothing ... declares compounding animal drugs from bulk ingredients illegal."

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). 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.