t was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, enacted by President Theodore Roosevelt less than 32 years before on June 30, 1906. Clocking in at just under 20 pages of text, the Public Law version of the 1938 FDC Act, 52 Stat. 1049, is a far cry from the 700-plus page behemoth statute of today. (The June 11, 1938 Conference Report on S. 5, which became the FDC Act, was also quite short – just 24 pages in length. See our previous post on the expansion of the FDC Act and FDA regulations.) And the statute will continue to expand with likely changes to the law concerning drug compounding and drug supply chain (i.e., track and trace) currently being debated by Congress.
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