Veterinary Regulations and Agencies
Determining which US agency regulates veterinary products can be very different from regulations as they apply to human pharmaceuticals, biologics and devices. Veterinary products in the United States, such as vaccines, drugs, ectoparasitics and certain diagnostics require formal approval processes to be legally marketed. However, other veterinary products, such as supplements, IV fluids, biomarkers, and medical devices may not require a formal approval process, but may be subject to certain labeling and manufacturing requirements. For most products, there are three primary US regulatory agencies which regulated veterinary products, being the FDA-CVM, USDA-APHIS, and EPA.
Prior to starting development, it is important to understand which veterinary regulations apply as this can affect study requirements, labeling, manufacturing, and distribution of the end use product. In most cases, the regulatory purview is based on the product’s mechanism of action (chemical reaction within the body, metabolism, immune modulation, topical insecticidal, etc.). The following generally describes the various veterinary regulatory agencies and the veterinary products they regulate.
Video on Veterinary Pharmaceuticals and the Food and Drug Administration’s Center for Veterinary Medicine
US Veterinary Regulations (additional information)
Veterinary Regulatory Links