In the wake of having issued a series of guidances in the latter part of 2014 to enable implementation of the 2013 Drug Supply Chain Security Act (DSCSA), FDA is now concentrating on: ● reviewing the comments and finalizing the guidances ● issuing required regulations ● scheduling public meetings ● performing a supply chain pilot program, and ● developing a licensing program for the various trading partners in the supply chain.
Four draft and two final guidances have been released since mid-2014 to support the track and trace provisions of DSCSA, which is the second component (Title II) of the Drug Quality and Safety Act (DQSA). Five of the guidances were required by the law, and one – on national uniform standards and federal preemption – was not, but was prompted by stakeholder requests for clarification on the topic.
At a meeting on DQSA implementation in December, co-sponsored by the Food and Drug Law Institute (FDLI) and the University of Maryland Schools of Law and Pharmacy, FDA Center for Drug Evaluation and Research (CDER) Office of Compliance Deputy Director Ilisa Bernstein reviewed DSCSA’s implementation status and the agency’s upcoming plans.
Also in focus at the meeting, held at the Washington, DC office of the law firm Arnold and Porter, was the Compounding Quality Act (CQA), which is Title I of DQSA. [Editor’s Note: A review will follow later in IPQ of the discussions at the FDLI meeting on the challenges that are presenting themselves in implementing CQA. See IPQ July 30, 2014 for more insights on the background and regulatory implementation challenges of DSCSA from a leading CDER official involved.]