Inter-governmental Working Meeting on Pharmacy Compounding, November 16-17, 2015
- Meeting Summary (PDF - 49KB)
- Meeting Agenda (PDF - 103KB)
- FDA Responses to Action Items From November 16-17, 2015 Inter-governmental Working Meeting on Pharmacy Compounding
On November 16-17, 2015, FDA convened its fourth 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).
Meeting Presentations
- Jane Axelrad â Compounding Regulatory Policy Update
- Jane Axelrad â Draft Standard Memorandum of Understanding between FDA and the States
- Beth Ferguson â Draft Standard Memorandum of Understanding between FDA and the States
- Kimberly Grinston â Draft Standard Memorandum of Understanding between FDA and the States
- Sarah Kotler, Lauren DiPaola â Information Sharing and Disclosure
- Ian Deveau â A Comparison of U.S. Pharmacopeial Convention General Chapter 797 to the Current Good Manufacturing Practice Regulations Enforced by FDA
- Ellen Morrison â Inspections of Sterile Compounding Facilities and Enforcement
- Mike Levy â Inspections of Sterile Compounding Facilities and Enforcement
- Allison Dudley â State Handling of Outsourcing Facilities
- Michael Dupuis â State Handling of Outsourcing Facilities