Inter-governmental Working Meeting on Pharmacy Compounding, March 18-19, 2015
- Meeting Summary (PDF -61KB)
- Meeting Agenda (PDF - 100KB)
- FDA Responses to Action Items From March 18-19, 2015 Inter-governmental Working Meeting
On March 18-19, 2015, the U.S. Food and Drug Administration (FDA) convened its third inter-governmental working meeting of state government officials (including the District of Columbia and Puerto Rico). Attendees included officials from the state Boards of Pharmacy and Health Departments and organizations that represent state officials, including the National Association of Boards of Pharmacy (NABP) and the Association of State and Territorial Health Officials (ASTHO).
The purpose of this meeting was to discuss oversight of compounding, including implementation of the Drug Quality and Security Act (DQSA), and to identify opportunities to better protect the public health by strengthening oversight of compounders through improved federal-state collaboration.
FDA previously held inter-governmental working meetings with state officials and their designated representatives in December 2012 and in March 2014. FDA initiated these meetings after the 2012 fungal meningitis outbreak associated with contaminated compounded drugs, involving illnesses and deaths across many states.
- Jane A. Axelrad - Compounding Policy Overview
- Jane A. Axelrad - Draft Standard Memorandum of Understanding (MOU)
- Jane A. Axelrad -Bulk Drug Substance Lists
- Mark D. Johnston and John Clay Kirtley - Memorandum of Understanding Under Section 503A
- Jane A. Axelrad - Outsourcing Facility Registration Issues
- Linda M. Bethman - Maryland: Response to DQSA - Outsourcing Facilities
- Cheri Atwood, R.Ph - Mississippi Board of Pharmacy
- Sarah Kotler and Lauren DiPaola - Sharing Non-Public Information
- Alonza Cruse - Update on Inspections of Sterile Drug Compounding Facilities
- Michael Levy, J.D. - FDA Regulatory Actions Involving Drug Compounding
- Gay Dodson, R.Ph - Sterile Compounding Enforcement
- Eric Nelson - Animal Drug Compounding
- Hal Wand - Arizona Veterinary or Is it Pharmacy
- Steve Hart, R.Ph - Veterinarian Compounding Issues in Kentucky