Inter-governmental Working Meeting on Pharmacy Compounding, September 26-27, 2017

• Meeting Agenda (PDF - 293KB)
• Meeting Summary (PDF - 84KB)
• Remarks for the 50 State Intergovernmental Meeting to Discuss Pharmacy Compounding

• FDA Responses to Action Items from September 26-27, 2017 Inter-governmental Working Meeting on Pharmacy Compounding

On September 26-27, 2017, the U.S. Food and Drug Administration convened its sixth 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 Federation of State Medical Boards (FSMB), and representatives from the Centers for Disease Control and Prevention (CDC).

The purpose of this meeting was to discuss oversight of compounding, including implementation of the Compounding Quality Act (CQA), which Title I 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, March 2015, November 2015 and November 2016. FDA initiated these meetings after the 2012 fungal meningitis outbreak associated with contaminated compounded drugs, involving illnesses and deaths across many states.

Meeting Presentations

• Gail Bormel – Compounding Special Issues (PDF - 187 KB)
• Ellen Morrison – FDA Inspections of Outsourcing Facilities (PDF - 1 MB)
• Kari Shanard-Koenders – Perspectives on Oversight of Compounding in Long Term Care (PDF -  600 KB)
• Ruey Ju – Combination Products/New Technologies/Difficult to Compound Products (PDF - 68 KB)
• Steve Hart – Kentucky Daniel Boone’s Wilderness (PDF - 687 KB)
• Sara Rothman – Compounding Radiopharmaceuticals (PDF - 93 KB)
• Kathy Anderson – Information Sharing and Collaboration (PDF - 138 KB)
• José Martinez, Jr. – Information Sharing and Technical Assistance (PDF - 97 KB)
• Susan Alverson – Working with the FDA and FDA’s Data (PDF - 275 KB)
• Beth Ferguson – Information Sharing: FDA and Minnesota State Board of Pharmacy (PDF - 391 KB)
• Russell Fortney – 503A  Compliance Assessment (PDF - 1 MB)
• Ian Deveau – FDA Inspectional Observations and Corrective Actions (PDF - 183 KB)
• Susan Laska – Key Elements of Outsourcing Facilities Inspections (PDF - 284 KB)