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»  Posts By   December 2012 

Compounding and the FDA

For decades there has been an unanswered question hanging over compounding pharmacies and, for that matter, federal regulators: are compounded prescriptions subject to the "new drug" requirements of the federal Food, Drug and Cosmetic Act (FDCA)? The answer has emerged recently in some federal court decisions and that answer is: yes, but . . . (and the "but" is a big one, as this article explains). Some background is helpful....