In the U.S., the key piece of legislation or law that sets the framework to insure that safe and effective pharmaceutical products reach and are maintained in the marketplace is the Federal Food, Drug and Cosmetic Act (FDCA)1 [http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm] . Today's version of the FDCA is the culmination of numerous modifications or amendments to the original legislation that was enacted in 1938 as the result of deaths due to a sulfanilamide product that contained diethylene glycol or antifreeze in the formulation. The 1938 FDCA set a requirement that safety needed to be demonstrated for drugs and before a new drug could be introduced into interstate commerce a new drug application (NDA) needed to be submitted to FDA. Drug products marketed before 1938 were however exempted from the FDCA (i.e., "grandfather drugs").
Historical and more current amendments to the FDCA include the Durham-Humphrey Amendment of 1951, the Kefauver-Harris Amendments of 1962, the Drug Listing Act of 1972, the National Environmental Policy Act of 1974, Medical Device Amendments of 1976, the Orphan Drug Act of 1983, the Drug Price Competition, and Patent Term Restoration Act of 1984 (i.e., Waxman-Hatch Amendments), the Drug Exports Amendments Act of 1986, the Prescription Drug Marketing Act of 1988, the Safe Medical Devices Act of 1990, the Prescription Drug User Fee Act (PDUFA) of 1992, the FDA Modernization Act (FDAMA) of 1997 and the Best Pharmaceuticals Act for Children of 2002. Of the nine chapters in the present FDCA, the key chapters and sections related to drugs include and address the following.
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