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 regulated under the purview of either the FDA-CVM or USDA-APHIS.
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.
US Veterinary Regulations (additional information)
Veterinary Regulatory Links