Alerts and Updates
Drug Quality and Security Act Does Not Apply to Veterinary Compounding
March 6, 2015
FDA has confirmed that the 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 the U.S. Food and Drug Administration (FDA) retains enforcement discretion with respect to activities that raise the kinds of concerns associated with a drug manufacturer.
DQSA never purported to alter regulation of veterinary compounding. By its very first line, DQSA is "An Act to amend the Federal Food, Drug, and Cosmetic Act [FDCA] with respect to human drug compounding … ." As discussed in more detail in an earlier Duane Morris Alert, Title I of DQSA amended Section 503A of the FDCA and added Section 503B. Both sections provide exemptions from certain FDA requirements for compounding pharmacies in the context of human medicine, including an exemption from Section 505's requirement for new drug approval of pharmaceuticals for use in humans.
FDA has confirmed that DQSA does not apply to veterinary compounding. In its July 2014 Guidance, "Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act," FDA explained that "Section 503A does not apply to drugs intended for use in animals" as the laws and regulations governing compounding human medications differ from the laws and regulations governing veterinary compounding. Similarly, in a February 2015 Stakeholder Call regarding recently released draft guidance documents pertinent to DQSA, Jane Axelrad, Associate Director for Policy of the Center for Drug Evaluation and Research, reiterated FDA's position that Sections 503A and 503B do not apply to veterinary compounding.
As such, veterinary compounding remains regulated primarily by state law and state pharmacy regulatory authorities. FDA set forth its current policy in a Compliance Policy Guide, "Compounding of Drugs for Use in Animals," published in July 2003 (2003 CPG). In the 2003 CPG, FDA explained that "Generally, FDA will defer to state authorities regarding the day-to-day regulation of compounding by veterinarians and pharmacists of animal and human drugs that are intended for use in animals." FDA retained enforcement discretion when the nature and scope of activities raised the types of concerns normally associated with drug manufacturers. This is consistent with FDA's enforcement authority over drug manufacturing, and FDA's deference to state authorities for regulation of the practice of pharmacy.
FDA has stated that it intends to develop new policy guidance with respect to veterinary compounding. Among the guidances under development for 2015 is "Draft Guidance for Industry—Compounding Animal Drugs from Bulk Drug Substances." Also, in a January 2014 letter, members of Congress asked the U.S. Government Accountability Office (GAO) to conduct a study on the compounding of drugs for use in animals to help inform Congress' future consideration of policy for veterinary compounding. This letter reiterated that DQSA is limited to compounded drugs for use in human medicine. During 2014, the GAO undertook several meetings with stakeholders concerning veterinary compounding, although the GAO has not yet issued a report from its study of animal compounding.
For decades, the practice of pharmacy, including the practice of compounding medications for use in treating animal patients, has been governed by state laws and regulations. DQSA did not change this regulatory framework for veterinary compounding.
For Further Information
If you have any questions about this Alert or would like more information, please contact Rachael G. Pontikes; Patrick C. Gallagher, Ph.D.; Alison T. Rosenblum; any of the attorneys in our Pharmaceutical, Medical Device, Pharmacy and Food industry group; or the attorney in the firm with whom you are regularly in contact.
- FDA Guidance, "Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act," at 2 n.3 (July 2014).
- Jane Axelrad, Associate Director for Policy of the Center for Drug Evaluation and Research, Food and Drug Administration, DQSA Stakeholder Call (Feb. 13, 2015) (available for 30 days after Feb. 13 by calling 1-800-947-5189).
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.