Compounding Quality Act Implementation Discussed by State and Federal Officials at Inter-Governmental Meeting

To identify opportunities to better protect the public health by strengthening oversight of compounding practice and improving federal-state collaboration, an intergovernmental meeting was convened by Food and Drug Administration (FDA) on March 20-21, 2014, in Silver Spring, MD. Participants at the meeting, including representatives from the boards of pharmacy, health departments, Centers for Disease Control and Prevention, and representatives from organizations that represent state officials, including NABP, discussed oversight of compounding pharmacies and the implementation of the Compounding Quality Act, Title I of the Drug Quality and Security Act (DQSA).

The meeting began with an overview of DQSA and the compounding provisions in Section 503A of the Federal Food, Drug, and Cosmetic Act. The meeting also included discussions about federal and state communications. Other topics included inspections of sterile compounding facilities and enforcement, regulating interstate distribution of compounded drugs, state adverse event reporting, and state enforcement priorities. A meeting agenda along with a summary of the proceedings are available on the FDA website.

FDA previously held an inter-governmental working meeting with state officials and their designated representatives in December 2012 in response to the fungal meningitis outbreak.