FDA discusses animal drug compounding with stakeholders

By: Dr. Ashley Morgan, assistant director, Governmental Relations Division

Last week, the AVMA participated in a roundtable discussion with the Food and Drug Administration (FDA) on animal drug compounding issues.

The discussion was prompted by the FDA’s recent actions to implement the Drug Quality and Security Act (DQSA), which the president signed into law last November. The new law amends the Federal Food, Drug and Cosmetic Act with respect to the regulation of human drug compounding. Although the law only applies to compounding in human medicine, the FDA is interested to hear any comments or concerns that its stakeholders, including veterinarians, may have on current and future regulation of animal drug compounding.

The AVMA provided comments to the agency, which reflect the association’s updated policies on animal drug compounding, and engaged in a discussion with the FDA and other stakeholders. Also in attendance were representatives from the American Association of Equine Practitioners, American Animal Hospital Association, Animal Health Institute, and International Academy of Compounding Pharmacists.

Separate from this work, the Government Accountability Office (GAO) has initiated its own study on the compounding of drugs for use in animals. Congressional offices requested the study after provisions regarding animal drug compounding were not included in the enacted version of the DQSA. The AVMA has spoken with representatives at the GAO and will continue to be a resource as its study takes shape.

The AVMA’s recently appointed Task Force on Veterinary Compounding Legislation will meet at the association’s Washington, D.C., office in August to continue discussions with stakeholders and agencies on this important issue.

For more information, see AVMA’s compounding Web page.

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