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U.S. Department of Health and Human Services

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What are Veterinary Biologics (including vaccines) and is FDA responsible for these products?

The term "veterinary biologics" includes all viruses, serums, toxins, or analogous products of natural or synthetic origin 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. Such products include but are not limited to vaccines, bacterins, allergens, antibodies, diagnostics, antitoxins, toxoids, immunostimulants, antigenic or immunizing components of microorganisms intended for use in the prevention, diagnosis, management or cure of disease in animals. FDA does not regulate vaccines for animals. The Veterinary Biologics Staff, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, is responsible for regulating veterinary biologics for purity, safety, potency and effectiveness. Additional information can be found at USDA Veterinary Biologics Web site.

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