New Law Extends Federal Oversight of Compounding Pharmacies, Establishes National Drug Track-and-Trace Requirements



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On November 27, 2013, President Obama signed the Drug Quality and Security Act into law. This legislation addresses two hot-button issues relating to marketed drug products: the extent of federal oversight of compounding pharmacies, and the establishment of a long-sought uniform national drug track-and-trace system. In this White Paper, we provide an overview of the provisions of the new law and the impact of these changes on drug manufacturers, distributors and purchasers of drug products. Compounding pharmacies and purchasers of compounded drugs should take note of the changes in federal oversight of compounded drugs. Further, given the significant operational impact of the track-and-trace provisions on the distribution and sale of drug products, all regulated entities involved in the manufacture and sale of drug products should review their current track-and-trace systems and their commercial drug distribution contracts, and carefully monitor future U.S. Food and Drug Administration communications regarding implementation of the new system and requirements.

Please click here to view the entire White Paper in Adobe PDF format.

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