Regulation of conditionally licensed biologicals in the United States.
The Virus-Serum-Toxin Act of 1913 (21 US Code 151-159) provides the legal basis for the regulation of veterinary biologicals in the United States and the United States Department of Agriculture's Center for Veterinary Biologics (CVB) has the regulatory authority for the issuing of licences and permits for such products. The law was intended to establish standards and control the importation of products into the United States and the distribution of products interstate assuring the purity, safety, potency, and efficacy of veterinary biological products. Under certain specific circumstances, product licences may be issued in the United States under expedited procedures which assure purity, safety, and a "reasonable expectation" of efficacy. These conditional licences may be authorized to meet an emergency condition, limited market, local situation, or other special circumstances, and provide valuable tools for veterinarians and consumers in improving animal health.
Hill
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Center for Veterinary Biologics, USDA, Animal and Plant Health Inspection Service, Veterinary Services, Ames, IA 50010, USA. rick.e.hill@aphis.usda.gov
D001688:Biological Products / Q000009:adverse effects; D033161:Government Regulation; D008004:Licensure / Q000331:legislation & jurisprudence*; D014481:United States
D001688:Biological Products