On Jul. 1, 1902, the Biologics Control Act, also known as the Virus-Toxin Law, was enacted by the U.S. Congress regulating the production of vaccines and antitoxins. It charged the government laboratory with regulating the production of vaccines and antitoxins, thus making it a regulatory agency four years before passage of the better-known 1906 Pure Food and Drugs Act.

The Act mandated annual licensing of establishments that manufactured or sold vaccines, serums, antitoxins, and similar products in interstate commerce. Before its passage, numerous deaths were caused by diphtheria vaccines tainted with tetanus. The Hygienic Laboratory of the US Public Health and Marine Hospital Service was charged with enforcing the law.

Following its passage, Surgeon General A.H. Glenran urged Joseph Remington and the Committee of Revision to adopt the Hygienic Laboratory’s standard for diphtheria antitoxin. Following consideration about including biologic products with other drugs in the compendia, the committee voted 17 to 2 to admit the diphtheria antitoxin standard into USP VIII. The act represented the first federal drug control law passed since 1848, and paved the way for federal inspections and oversight of drug manufacturers.