Veterinary Product Regulations
In the US, animal health products are regulated by the Food and Drug Administration-Center for Veterinary Medicine (FDA-CVM), United States Department of Agriculture-Center for Veterinary Biologics (USDA-CVB), or Environmental Protection Agency (EPA) depending on their intended use and mechanism of action. Each agency has different regulatory approval requirements, so it is important for developers to understand the differences between the regulations as they apply to veterinary pharmaceuticals, veterinary medical devices, veterinary diagnostics and veterinary biologics. This page provides an overview of veterinary product regulations and links to Code of Federal Regulations (CFRs) and guidance documents concerning veterinary product regulations & development requirements for veterinary pharmaceuticals (FDA) and veterinary biologics (USDA).
Veterinary Pharmaceuticals
Veterinary pharmaceuticals, including feeds, devices, and supplements are regulated under and/or subject to regulations per the Food and Drug Administration – Center for Veterinary Medicine (FDA-CVM).
Code of Federal Regulations: Title 21 CFR Subchapter E: Animal Drugs, Feeds, and Related Products
Veterinary Biologics
Veterinary biologics, which include vaccines, diagnostic kits, and immune modulators are regulated by the United States Department of Agriculture – Center for Veterinary Biologics (USDA-CVB).
Code of Federal Regulations: Title 9 Animal and Animal Products; Subchapter E: Viruses, Serums, Toxins, and Analogous Products; Organisms and Vectors
Erdman MM, Clough NE, Hauer PJ. Review of updated regulations and product license categories for veterinary vaccines in the United States. J Am Vet Med Assoc. 2020 Dec 1;257(11):1142-1147. doi: 10.2460/javma.2020.257.11.1142. PMID: 33226286.
Animal Health Consultants Webpage – quick links
Hyperlinks contained on this page are associated with publicly accessible veterinary pharmaceutical and veterinary biologic documents. Documents may be subject to copyright of the FDA-CVM or USDA-CVB. Woods Consulting, LLC does not represent or warrant the accuracy of these documents.