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Allergen extract regulation
nThe agencies
n1902: Hygienic Laboratory, Public Health and Marine Hospital Service
n1930: National Institute (sic) of Health
n1955: Division of Biologics Standards, NIH
n1972: Bureau of Biologics, FDA
n1982: Center for Drugs and Biologics, FDA
n1987: Center for Biologics Evaluation and Research, FDA
nThe laws
nBiologics Control Act of 1902
nFood and Drugs Act of 1906
nFood Drug and Cosmetic Act of 1938 nPublic Health Service Act of 1944 nFood and Drug Administration Modernization Act of 1997
http://www.fda.gov/opacom/backgrounders/miles.html
http://www.history.nih.gov/exhibits/history
1901: thirteen children in St. Louis died after receiving diphtheria antitoxin contaminated with tetanus spores. Spurred Congress into passing the Biologics Control Act.

1906: Shocking disclosures of insanitary conditions in meat-packing plants, the use of poisonous preservatives and dyes in foods, and cure-all claims for worthless and dangerous patent medicines were the major problems leading to the enactment of these laws.

1937:
ELIXIR OF SULFANILAMIDE, containing the poisonous solvent diethylene glycol, kills 107 persons, many of whom are children, dramatizing the need to establish drug safety before marketing and to enact the pending food and drug law.