Licensing and Permitting of Veterinary Vaccines in the USA: US Regulatory Requirements

Abstract

The Center for Veterinary Biologics (CVB), United States Department of Agriculture (USDA), located in Ames, Iowa, has regulatory jurisdiction over veterinary biologics in the USA for the diagnosis, prevention, and treatment of animal diseases. Regulatory jurisdiction is established by the Virus-Serum-Toxin Act (VSTA) [1] of 1913 (amended in 1985) which requires that all veterinary biologics available within the USA are pure, safe, potent, and effective (not worthless, dangerous, contaminated, or harmful). Regulations can be found in Title 9 of the Code of Federal Regulations (9 CFR), Subchapter E, Parts 101–122 [2]. Veterinary Services Memoranda (VS Memo) that are available online provide detailed requirements with more specific guidance. The Web site provides links to the relevant guidance documents [3]. It is important to note that the USDA has regulatory authority only over those veterinary vaccines specifically for the prevention and treatment of animal diseases; the Food and Drug Administration (FDA) has regulatory jurisdiction over veterinary vaccines for other purposes (e.g., vaccines targeting some hormones or pain receptors). This chapter provides an overview of the regulations and guidance for licensing (products produced in the USA) and permitting (products produced outside the USA but sold within the USA) those vaccines under USDA regulatory jurisdiction.