Food, Drug, And Cosmetic Act (FDCA)

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Although there had been some earlier calls to require pre-market safety testing, it was due in large measure to the public outcry over the Elixir Sulfanilamide incident that Congress passed the Food, Drug, and Cosmetic Act of 1938 (FDCA). The previous year, Elixir Sulfanilamide, a drug which had been used for years in tablet and powder form to treat streptococcal infections, was converted to a liquid form. The new liquid version of Elixir Sulfanilamide used diethylene glycol as a solvent, a poisonous compound. Tragically, the company was unaware of the solvent’s deadly effects. Within days of the first shipments, the drug began to claim lives across the country. Before the drug could be recalled by the manufacturer, more than 100 people had

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