FDCA 1938
FDCA 1938
FDCA 1938 is an act United States Federal Food, Drug, and Cosmetic Act in shortly as FFDCA, FDCA, or FD&C. it is a set of laws passed by Congress in 1938 imparting authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. The introduction of this act was influenced through the death of over 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form. See Elixir Sulfanilamide disaster. It replaced the before Pure Food and Drug Act of 1906.
The act has been improved many times; most recently to add requirements regarding bioterrorism preparations. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York. In 1968, the Electronic Product Radiation Control provisions were contributed to the FD&C. Also in that year the FDA organized the Drug Efficacy Study Implementation (DESI) to integrate into FD&C rules the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs.
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