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Abstract:  The question of whether all compounded drugs are “new drugs” has been disputed in the United States for over 15 years. The Federal Food, Drug, and Cosmetic Act generally requires that “new drugs” obtain U.S. Food and Drug Administration approval before being sold in the U.S. Between 1938 and the late 1980s, the U.S. Food and Drug Administration did not assert that compounded drugs are subject to the new drug provisions. Then, the U.S. Food and Drug Administration developed and advanced a new theory. As articulated in a 1989 memorandum by a U.S. Food and Drug Administration attorney, the U.S. Food and Drug Administration could take the position that compounded drugs were new drugs and therefore subject to new drug approval requirements. Although the memorandum acknowledged that this represented a significant change in policy, the U.S. Food and Drug Administration adopted this legal theory. Their position that compounded drugs are new drugs led to a clash between the agency and compounding pharmacies. Congress

Related Keywords: Jeffrey N. Gibbs, BA, JD, pharmacy regulation, pharmacy law, legal cases, U.S. Food and Drug Administration, FDA, unapproved new drugs

Related Categories: LEGAL, PROFESSIONAL ISSUES

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