New Law Extends Federal Oversight of Compounding Pharmacies, Establishes National Drug Track-and-Trace Requirements
January 22,
2014
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.
Please click here to view the entire White Paper in Adobe PDF format.