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[21] Because of the way it was derived in the early twentieth century, diphtheria antitoxin was extremely susceptible to contamination.  In 1901, thirteen children in St. Louis died after receiving diphtheria antitoxin that was contaminated with tetanus spores.  This incident led to the passage of the Biologics Control Act by the US Congress in 1902.  The Act established standards for the production and safety of biological products such as serums and vaccines, and can be considered a major milestone in the history of food and drug regulation, and the eventual creation of the Food and Drug Administration, in the United States.  See the FDA’s “Significant Dates in U.S. Food and Drug Law History” (http://www.fda.gov/AboutFDA/WhatWeDo/History/ Milestones/default.htm, accessed 2/20/2013) and the Office of NIH History’s “Short History of the National Institutes of Health” (http://history.nih.gov/exhibits/history/index.htmlShort History of the National Institutes of Health, accessed2/20/2013)

[22] See A. Shelokov, K. Habel, E. Verder, W. Welsh (1957), “Epidemic neuromyasthenia; an outbreak of poliomyelitislike illness in student nurses,” New England Journal of Medicine 257 (8): 345-55.

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