Biologics Control Act
|Long title||An Act to regulate the sale of viruses, serums, toxins, and analogous products in the District of Columbia; to regulate interstate traffic in said articles, and for other purposes.|
|Enacted by||the 57th United States Congress|
|Effective||July 1, 1902|
|Statutes at Large||32 Stat. 728, Chapter 1378|
In 1887, the United States' first bacteriological laboratory was established by Joseph Kinyoun at the Marine Health Service Hospital at Staten Island, New York. In 1891, the Laboratory of Hygiene was relocated to Washington, D.C. The Hygienic Laboratory developed procedures for diphtheria antitoxin and provided licensing for biological manufacturers. The Biologics Control Act mandated producers in the United States to be licensed annually for the manufacture and sale of antitoxins, serum, and vaccines.
In 1930, the Hygienic Laboratory was titled the National Institute of Health. In 1937, the Division of Biologics Control was formed within the National Institute of Health. In 1972, the Division of Biologics was transferred from National Institute of Health to the U.S. Food and Drug Administration and renamed the Bureau of Biologics.
In 1901, the first incident involved the horse named Jim whose tetanus-contaminated serum was used to produce a diphtheria antitoxin that caused the deaths of thirteen children in St. Louis, Missouri.
The second incident involved contaminated smallpox vaccine which killed nine children in Camden, New Jersey. Both incidents were attributed to failure of proper procedures and testing by local officials.
- "Biologics: A Short History of the National Institutes of Health". Office of National Institutes of Health History. May 16, 2010.
- "Birth of the Hygienic Laboratory". Origins of the National Institutes of Health. U.S. National Library of Medicine. May 8, 1987.
- "The Road to the Biotech Revolution - Highlights of 100 Years of Biologics Regulation". FDA Consumer magazine The Centennial Edition / January-February 2006. U.S. Food and Drug Administration. January 19, 2012.
- "Science and the Regulation of Biological Products". U.S. Food and Drug Administration. April 9, 2009.
- "The St. Louis Tragedy and Enactment of the 1902 Biologics Control Act". U.S. Food and Drug Administration. April 9, 2009.
- Junod, Suzanne White (May 21, 2009). "Biologics Centennial: 100 Years of Biologics Regulation". U.S. Food and Drug Administration.