Flowchart created to help clarify which agency will regulate a given animal biological product.
December 17, 2024
The U.S. Department of Agriculture’s Animal & Plant Health Inspection Service (APHIS) and the U.S. Food & Drug Administration announced Dec. 17 they are making available a charter that details how the two agencies work together to determine the appropriate agency to regulate a small number of animal biologicals for which jurisdiction may be unclear.
According to FDA, animal biologicals are subject to both the Federal Food, Drug & Cosmetic (FD&C) Act and APHIS’s Virus, Serum, Toxin Act (VSTA).
Under VSTA, animal biological products are defined in part as “all viruses, serums, toxins (excluding substances that are selectively toxic to microorganisms, e.g., antibiotics) or analogous products at any stage of production, shipment, distribution or sale which are intended for use in the treatment of animals and which act primarily through the direct stimulation, supplementation, enhancement or modulation of the immune system or immune response.”
FDA noted that although animal biological products are "drugs" within the meaning of the FD&C Act, animal drugs produced and distributed in full conformance with the VSTA are not subject to the animal drug approval requirements in section 512 of the FD&C Act.
The charter outlines the collaborative process by which both agencies will make jurisdictional determinations on the regulation of products as either veterinary biologics under the VSTA or drugs under the FD&C Act.
Representatives from APHIS and FDA originally signed a memorandum of understanding (MOU) in 2013 (FDA MOU 225-05-7000) outlining which animal biologicals each would regulate. Since 2013, the two agencies explained that 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 APHIS Center for Veterinary Biologics and the FDA Center for Veterinary Medicine 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 FD&C Act or biological products under the VSTA.
The new charter update 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 APHIS and FDA 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, the statement noted.
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