FDA Inter-governmental Working Meeting on Pharmacy Compounding held March 18-19, 2015 with meeting materials from FDA, and a number of boards of pharmacy

Meeting Presentations

• Jane A. Axelrad – Compounding Policy Overview (PDF - 64KB)
• Jane A. Axelrad – Draft Standard Memorandum of Understanding (MOU) (PDF - 49KB)
• Jane A. Axelrad – Bulk Drug Substance Lists (PDF - 35KB)
• Mark D. Johnston and John Clay Kirtley – Memorandum of Understanding Under Section 503A (PDF - 201KB)
• Jane A. Axelrad – Outsourcing Facility Registration Issues (PDF - 31KB)
• Linda M. Bethman – Maryland: Response to DQSA – Outsourcing Facilities (PDF - 739KB)
• Cheri Atwood, R.Ph – Mississippi Board of Pharmacy (PDF - 17KB)
• Sarah Kotler and Lauren DiPaola – Sharing Non-Public Information (PDF - 393KB)
• Alonza Cruse – Update on Inspections of Sterile Drug Compounding Facilities (PDF - 1.5MB)
• Michael Levy, J.D. – FDA Regulatory Actions Involving Drug Compounding (PDF - 47KB)
• Gay Dodson, R.Ph – Sterile Compounding Enforcement (PDF - 156KB)
• Eric Nelson – Animal Drug Compounding (PDF - 182KB)
• Hal Wand - Arizona Veterinary or Is it Pharmacy (PDF - 3.8MB)
• Steve Hart, R.Ph – Veterinarian Compounding Issues in Kentucky (PDF - 445KB)