What licenses or permits are required to manufacture and sell veterinary biologics?
Domestic manufacturers of veterinary biologics, for domestic use or for export, are required to possess a valid U.S. Veterinary Biologics Establishment License and an individual U.S. Veterinary Biologics Product License for each product produced for sale. Foreign manufacturers of veterinary biologics may export veterinary biologics to the United States, provided that the manufacturer’s legal representative (permittee) residing in the United States possesses a valid U.S. Veterinary Biological Product Permit to import these products for general distribution and sale. The U.S. Department of Agriculture may also issue veterinary biologics permits for research and evaluation or for transit shipment.
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