Production of Biologicals Under New Government Regulations

Abstract

The Federal Government regulates the veterinary biologics industry by a law (often called the Serum-Virus-Toxin Act) enacted in March 1913. This law gives the Secretary of Agriculture authority to control the interstate movement of products for veterinary use and to insure that these products are not worthless, contaminated, dangerous, or harmful under the Act.

The Secretary of Agriculture has presently delegated the authority for biological products to the Animal and Plant Health Inspection Service. 162 The Biologics Staff of Veterinary Services of this agency establishes conditions for licensing for both the production facility and individual products. Any person, corporate or individual, technically qualified, who can provide adequate laboratory facilities for production and testing, and with sufficient data to license at least one biological product, can become a producer of veterinary biologicals. Before you rush to Washington for a U.S. veterinary license, let us consider some of the detail that is required today in veterinary biological production.