CDER Compliance Office Quality Regulatory Priorities for 2014 Include Implementing DQSA, FDASIA and Reorganization Plans

The top priorities at FDA’s Center for Drug Evaluation and Research (CDER) compliance office in 2014 will include implementing the compounding (Title I) and track and trace (Title II) provisions of the Drug Quality and Security Act (DQSA), signed into law in late 2013, along with the ongoing implementation efforts on the generic drug user fee (Title I), supply chain (Title VII) and drug shortage (Title X) facets of the 2012 FDA Safety and Innovation Act (FDASIA).

Also on the CDER compliance office front burner for this next year will be carrying out the center’s plan to reorganize and realign its quality regulatory structures and strengthen its product and facility surveillance capabilities.

While FDA has already come forward with guidances and Federal Register notices to begin to give regulatory flesh to the Title 1 compounding provisions of DQSA (IPQ December 28, 2013), the agency has not yet formally addressed Title II. It calls for an electronic inter-operable system to identify and trace certain prescription (Rx) drugs as they are distributed through the US.

Providing a review of CDER’s current compliance priorities at the Food Drug Law Institute (FDLI) enforcement conference in Washington, D.C in December, CDER Compliance Office Director Ilisa Bernstein emphasized that the track and trace objectives called for in DQSA have been in the works for “over ten years,” and that implementation will require the agency to write guidances, publish regulations, hold public meetings, launch pilot projects, and write standards.

“We are really working hard at moving forward” on DQSA Title II implementation, Bernstein commented.

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