Licensing veterinary biologics in the United States.

The authority for the regulation of veterinary biologics in the United States is provided in the Virus-Serum-Toxin Act, enacted in 1913 and amended in 1985. The Act authorizes the Secretary of Agriculture to prescribe regulations governing the preparation and marketing of veterinary biologics shipped into, within, or from the United States. The veterinary biologics program carries out the mandate to ensure that all veterinary biological products under the U.S. jurisdiction are pure, safe, potent, and efficacious. The program is based on licensing, inspection, and testing. Establishment licensing defines the production facilities, manufacturing practices, and the responsible person. Product licensing defines the product, the method of production, and testing requirements; it also assures product purity, safety, potency, and efficacy. Biologics production is based on the Master Seed concept, in which a master parental stock is the source of all seed materials for production. The final product may not be more than five serial passages removed from the Master Seed. Host animal immunogenicity is demonstrated by statistically valid host animal vaccination and challenge studies using the minimum level of antigen at the highest level of passage. Potency tests are correlated to host animal immunogenicity and are conducted on each serial of product prior to release for marketing to assure efficacy. Conditional licensing procedures that assure purity, safety and a reasonable expectation of efficacy are used to provide products for emergency conditions, limited markets, local situations, or other special circumstances. Licensing for further manufacturing permits two or more licensees to work together in the production of a product.(ABSTRACT TRUNCATED AT 250 WORDS)