FDA's New Guidance on Compounding Bulk Drug Substances - Video

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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."

Full transcript (PDF, 373.49 KB)
Slide Deck (PDF, 5.68 MB)

Presenter(s)

Dorothy Bailey, D.V.M

[email protected]

Veterinary Medical Office
Office of Minor Use and Minor Species Animal Drug Development
FDA Center for Veterinary Medicine

Amber McCoig, D.V.M, M.P.H

[email protected]

Senior Veterinary Medical Officer
U.S. Food and Drug Administration (FDA)
Center for Veterinary Medicine (CVM)

Nicolette Petervary, D.V.M, M.S.

[email protected]

Director, Division of Policy and Education
Office of Laboratory Animal Welfare (OLAW)
Office of the Director (OD)
NIH, HHS

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