Drug Quality and Security Act Does Not Apply to Veterinary Compounding

While the Drug Quality and Security Act (DQSA) provided a new regulatory framework for compounded medications for use in human medicine, it does not apply to veterinary compounded medications. There has been some confusion in the industry, but veterinary compounded medications are still regulated by state pharmacy authorities, while FDA retains enforcement discretion over activities that raise the kind of concerns associated with a drug manufacturer. FDA has stated that it intends to develop new policy guidance with respect to veterinary compounding. Among the guidances under development by FDA for 2015 is “Draft Guidance for Industry—Compounding Animal Drugs from Bulk Drug Substances.”