Veterinary Compounding and the Drug Quality and Security Act

The Drug Quality and Security Act (DQSA) amends the Federal Food, Drug and Cosmetic Act (FDCA) with respect to human drug compounding. As discussed previously on the Baer Law Blog, Title I of the DQSA amended Section 503A of the FDCA and added Section 503B. Sections 503A and 503B address exemptions from certain FDA requirements for compounding pharmacies regarding medications for human use.

In short, DQSA does not apply to veterinary compounding and the Food and Drug Administration (FDA) has confirmed as much through its July 2014 Guidance, stating, “Section 503A does not apply to drugs intended for use in animals,” since the laws and regulations governing compounding human medications differ from the laws and regulations governing veterinary compounding.

Veterinary compounding is generally regulated by state boards of pharmacies. The FDA has historically deferred to these state authorities regarding the day-to-day regulation of compounding by pharmacists and veterinarians of animal and human drugs that are intended for use in animals. However, the FDA retains some enforcement discretion regarding activities that are related to drug manufacturing.

The FDA intends to offer new policy guidance to address veterinary compounding once the results of its study on the compounding of drugs for use in animals is available and has been reviewed. Stay tuned to the Baer Law Blog for updates.