Inter-governmental Working Meeting on Pharmacy Compounding, September 20-21, 2016

• Meeting Summary (PDF - 82 KB)
• Meeting Agenda (PDF - 123 KB)
• FDA  Responses to Action Items From September 20-21, 2016 Inter-governmental Working Meeting on Pharmacy Compounding

On September 20-21, 2016, FDA convened its fifth inter-governmental working meeting of state government officials, including the District of Columbia and Puerto Rico. Attendees included officials from state Boards of Pharmacy and State Health Departments, representatives from 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) (Title 1 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 on compounding with state officials and their designated representatives in December 2012, March 2014, March 2015, and November 2015. FDA initiated these meetings after the 2012 fungal meningitis outbreak associated with contaminated compounded drugs, which lead to many serious illnesses across the country.

Meeting Presentations

• Julie Dohm and Sara Rothman – Compounding Regulatory Policy Update (PDF - 691 KB)
• Ellen Morrison – Update on Inspections of Drug Compounding Facilities (PDF - 388 KB)
• Michael Levy – Enforcement Update (PDF - 569 KB)
• Kathleen Anderson – FDA  Inspections and Enforcement Update: Changes in FDA Inspectional Procedures (PDF - 77 KB)
• Sara Rothman – Prescription Requirement Under Section 503A of the FD&C Act (PDF - 496 KB)
• Daniel Kelber – State of Illinois Prescription Requirements for Compounded Drugs (PDF - 144 KB)
• Linda M. Bethman – Prescription Requirements in Maryland (PDF - 84 KB)
• Sue Mears – Prescription Requirements (PDF -  333 KB)
• Sara Ashton, Lauren DiPaola, and Sarah Kotler – Sharing Non-Public Information (PDF - 503 KB)
• Kathleen Anderson and Gail Bormel – FDA/State Collaboration and Communication: How FDA Can Support State Actions (PDF - 411 KB)
• Emily Gebbia and Ian Deveau – Draft Guidance for Industry Insanitary Conditions at Compounding Facilities (PDF -14 MB)
• Gay Dodson – Sterile Compounding Inspections (PDF - 175 KB)
• Kimberly Leonard – Oversight of Pharmacies: Quality Standards and Insanitary Conditions (PDF - 118 KB)
• Kimberly Gaedeke – Oversight of Pharmacies; Accreditation and Inspections – Michigan Update (PDF -175 KB)
• Gail Bormel and Gabrielle Cosel – Oversight of Outsourcing Facilities (PDF - 348 KB)
• Carmen A. Catizone – Food and Drug Administration Fifty State Meeting (PDF - 289 KB)
• Virginia Herold – California’s Outsourcing Facility Licensure Program (PDF - 92 KB)
• Caroline Juran – FDA  Intergovernmental Meeting on Compounding (PDF - 73 KB)
• Emily Gebbia – Physician Compounding (PDF - 53 KB)
• Nadine Shehab – Identifying and Responding to Outbreaks Linked to Physician/Clinic Compounding (PDF - 1MB)
• Lisa Robin – Perspectives on Physician Compounding (PDF - 496 KB)
• Cameron McNamee – Prescriber Compounding (PDF - 183 KB)