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FDA and USDA Announce Charter to Clarify Jurisdiction for Animal Biologicals

December 17, 2024

Today, the U.S. Food and Drug Administration and the U.S. Department of Agriculture (USDA) are making available a charter that details how the two agencies work together to determine the appropriate agency to regulate the small number of animal biologicals for which jurisdiction may be unclear.

Representatives from the FDA and USDA originally signed a Memorandum of Understanding in 2013 (FDA MOU 225-05-7000) that outlined which animal biologicals each would regulate. Since 2013, science has continued to advance, and the jurisdiction of some products is not clear under the MOU. As regulatory science and the nature of animal biologicals have evolved over time, the FDA’s Center for Veterinary Medicine and the USDA’s Center for Veterinary Biologics have worked together to develop a common approach, consistent with the law, for both agencies to make jurisdictional determinations on the regulation of products as either drugs under the Federal Food, Drug, and Cosmetic Act or biological products under the Virus-Serum-Toxin Act. 

The charter includes a flowchart to help clarify which agency will regulate a given product, as well as information on how to request a jurisdiction determination from the FDA and USDA for animal biologicals. The charter also discusses the agencies’ approach for products with multiple claims where oversight may fall to both agencies and describes a reconsideration process for jurisdiction decisions.

For more information:

Issued by FDA Center for Veterinary Medicine. 
For questions, Contact CVM.

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