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Biologics Control Act information


Biologics Control Act of 1902
Great Seal of the United States
Long titleAn 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.
NicknamesVirus-Toxin Law
Enacted bythe 57th United States Congress
EffectiveJuly 1, 1902
Citations
Public law57-244
Statutes at Large32 Stat. 728, Chapter 1378
Legislative history
  • Signed into law by President Theodore Roosevelt on July 1, 1902

The Biologics Control Act of 1902, also known as the Virus-Toxin Law, was the first law that implemented federal regulations of biological products such as vaccines in the United States.[1] It was enacted in response to two incidents involving the deaths of 22 children who had contracted tetanus from contaminated vaccines.[2] This law paved the way for further regulation of drug products under the Pure Food and Drug Act of 1906 and the Federal Food, Drug, and Cosmetic Act of 1938. Biologics control is now under the supervision of the U.S. Food and Drug Administration (FDA).[3]

  1. ^ Affairs, Office of Regulatory. "100 Years of Biologics Regulation - Science and the Regulation of Biological Products". www.fda.gov. Retrieved 2017-05-05.
  2. ^ Milstien, Julie B. (2004). "Regulation of Vaccines: Strengthening the Science Base". Journal of Public Health Policy. 25 (2): 173–189. doi:10.1057/palgrave.jphp.3190016. PMID 15255384. S2CID 6219580.
  3. ^ "Selections From FDLI Update Series on FDA History - Biologics Centennial: 100 Years of Biologics Regulation". www.fda.gov. Retrieved 2017-05-05.

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