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Veterinary Biologics & Animal Disease

The Virus-Serum-Toxin Act (VST Act) (21 U.S.C. 151-158) is designed to protect farmers and persons raising livestock by regulating the quality of vaccines and point-of-care diagnostics for animals. The law and implementing regulations make it unlawful for any person, firm or corporation to engage in the "preparation, sale, barter, exchange, or shipment" of "worthless, contaminated, dangerous or harmful" virus, serum, toxin, or analogous animal biologicals in interstate commerce. The Act provides for licensing of products and establishments, and requires permits for the importation of animal biologicals. Regulations prescribe test requirements for purity, safety, potency, and efficacy; and all labeling and claims in advertising are subject to approval. The USDA's Animal and Plant Health Inspection Service (APHIS) enforces the VST Act. Animal biologicals are also subject to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) and FDA regulations. APHIS also regulates the importation and interstate transportation of animals and animal products to prevent the introduction and spread of various animal diseases in the U.S.

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