FDA's New Guidance on Compounding Bulk Drug Substances

Audience: The program is tailored to IACUC staff, IACUC members, IOs, veterinarians, investigators, compliance personnel, animal care staff, and others involved in animal programs.

Speakers:

• Amber McCoig, DVM, MPH, Senior Veterinary Medical Officer, Science Policy, Office of the Director at the US Food and Drug Administration (FDA) Center for Veterinary Medicine
• Dorothy Bailey, DVM, Veterinary Medical Officer in the Office of Minor Use and Minor Species Animal Drug Development at US FDA Center for Veterinary Medicine 
• Nicolette Petervary, VMD, MS, Director, Division of Policy and Education, NIH Office of Laboratory Animal welfare

Topic: In this webinar, Dr. Bailey presents information on the Indexing program and explains the difference between FDA indexed, approved, and conditionally-approved drugs. Dr. McCoig presents information on FDA’s new guidance for compounding from bulk substances, how FDA guidance applies to laboratory animal care and use, and answers questions from the laboratory animal community. Dr. Petervary clarifies OLAW's definition of "non-pharmaceutical grade substances."

Note: While this information was accurate at the time presented, policies and procedures change over time. Past webinars may not contain the most current guidance. Please note, do not rely on webinars and associated materials as definitive compliance guidance for your specific situation. For compliance questions, please contact OLAW directly.