Inter-governmental Working Meeting on Pharmacy Compounding, March 20-21, 2014
- Meeting Summary (PDF -62KB)
- Meeting Agenda (PDF - 111KB)
- FDA Responses to Action Items From March 20-21, 2014 Inter-governmental Working Meeting on Pharmacy Compounding
On March 20-21, 2014, the U.S. Food and Drug Administration (FDA) convened an inter-governmental working meeting of state government officials, including officials from the District of Columbia and Puerto Rico.
Attendees included officials from Boards of Pharmacy, Health Departments, the Centers for Disease Control and Prevention (CDC), and representatives from organizations that represent state officials, including the National Association of Boards of Pharmacy (NABP), the Association of State and Territorial Health Officials (ASTHO), and the National Conference of State Legislatures (NCSL).
During this meeting, participants discussed oversight of compounding pharmacies and implementation of the Drug Quality and Security Act (DQSA). The DQSA, P.L. 113-54, was signed into law on November 27, 2013, and contains provisions relating to federal and state oversight of compounded human drugs.
The purpose of this meeting was to identify opportunities to better protect the public health by strengthening oversight of compounders, including through improved federal-state collaboration.
FDA previously held an inter-governmental working meeting with state officials and their designated representatives in December 2012. That meeting came in the wake of a fungal meningitis outbreak associated with contaminated compounded drugs, involving many illnesses and deaths across many states.
- Jane Axelrad - Overview of Compounding Quality Act (PDF - 72KB)
- Sarah Kotler - Federal-State Communication (PDF - 56KB)
- Lauren DiPaola - Federal-State Communication (PDF - 198KB)
Tista Ghosh - Federal-State Communication Michele Weizer - Federal-State Communication
- Ellen Morrison - Inspections of Sterile Compounding (PDF - 666KB)
- Mike Levy - Inspections of Sterile Compounding (PDF - 42KB)
John Clay Kirtley - Inspections of Sterile Compounding
- Jane Axelrad – MOU (PDF - 43KB)
Carmen Catizone - MOU Mark Johnston - MOU
- Gerald Dal Pan - State Adverse Event Reporting (PDF - 723KB)
Joseph Perz - State Adverse Event Reporting Gay Dodson - State Enforcement Priorities Virginia Herold - State Enforcement Priorities Cody Wiberg - State Legislation-Regulation Margaret Clifford - State Legislation-Regulation Mitra Gavgani - State Legislation-Regulation