Regulation of veterinary biological products for fish in the United States.

The USDA regulates veterinary biological products for fish in the U.S. to ensure that they are pure, safe, potent and efficacious, and not worthless, contaminated, dangerous, or harmful. To market a biological, USDA establishment and product licences (for U.S. biologicals manufacturers) or a USDA permit (for U.S. representatives of biologicals manufacturers abroad) are required. The USDA will issue the appropriate licences or permit following submission of acceptable documentation by the applicant, inspection of production facilities and confirmatory testing by the USDA.