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

On November 27, 2013, President Obama signed the Drug Quality and Security Act (the Act) (Public Law No. 113-54) into law. The Act 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.

Oversight of Compounding Pharmacies -

The Act establishes an optional program that allows pharmacy compounders to voluntarily subject themselves to federal oversight by registering as an “outsourcing facility.” An “outsourcing facility” is a facility, geographic location or address that is engaged in the compounding of sterile drugs, has elected to register with the U.S. Food and Drug Administration (FDA) as an outsourcing facility, and has complied with the requirements of the Act.

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