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JOURNAL ARTICLE

Regulating compounding pharmacies after NECC

Kevin Outterson

New England Journal of Medicine 2012 November 22, 367 (21): 1969-72

Food and Drug Administration (FDA) rules are often forged in crisis. After the 1937 sulfanilamide disaster that killed more than 100 people, Congress passed the Food, Drug, and Cosmetic Act (FDCA), requiring drugs to be safe and properly labeled. In 1962, a requirement was introduced for proof of..

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