The Unites States Department of Agriculture Regulation of Veterinary Biological Products. The use of prelicensing evaluation and postlicensing monitoring to achieve regulatory compliance.

Abstract

The United Stated Department of Agriculture is responsible for regulating veterinary biological products in the United States, and the regulatory authority is provided in the Animal Virus-serum-Toxin Act of 1913. The act authorizes the Secretary of Agriculture to promulgate regulations for the production, testing, and marketing of veterinary biological products into, within, or from the United States. The current regulatory program consists of extensive prelicensing review of products, labeling, facilities, and personnel and a postlicensing monitoring system of unannounced in-depth inspections, premarketing control of product batches (serials), random check testing of finished product, and postmarketing epidemiological surveillance. This combination of regulatory oversight before and after licensure assures that pure, safe, potent, and effective veterinary biologics are available for use in the United States.