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.


  • 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."

Additional questions received during the webinar will be posted after 508 compliance processing for accessibility. 


Submit comments or questions here or send email OLAW at olawdpe@mail.nih.gov.

This page last updated on: Feb 3, 2023
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