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FDA's Authority to Regulate Drug Compounding: A Legal Analysis


In light of the recent meningitis outbreak, believed to have been caused by a contaminated compounded steroid injection, the regulation of drug compounding has received significant attention. Compounding is traditionally defined as a process of combining, mixing, or altering ingredients in order to create a medication for a particular patient. However, as in the case of the pharmacy that produced the steroid medication, concerns have been raised about compounding pharmacies producing drugs on a larger scale, something more akin to drug manufacturing. While drug compounding has historically been regulated primarily by states through their regulation of pharmacies, recent questions have been raised about the extent to which the Federal Food, Drug, and Cosmetic Act (FFDCA) governs this practice, and what authority the U.S. Food and Drug Administration (FDA) has to regulate a compounded drug as a "new drug," subject to approval by the FDA, as well as other requirements.


THE DOCUMENT INCLUDES FOLLOWING FILES:
# FILE NAME Document Date Order ID: Number of Pages PRICE
1 R40503.pdf Oct 17, 2012 R40503 11 $19.95 ADD TO CART

Older Versions:

FDA's Authority to Regulate Drug Compounding: A Legal Analysis  [Order No: R40503  Release Date: Jan 29,2010  Pages: 11]

FDA's Authority to Regulate Drug Compounding: A Legal Analysis  [Order No: R40503  Release Date: Apr 08,2009  Pages: 11]