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GUIDANCE DOCUMENT

CVM GFI #211 Residual Solvents in Animal Drug Products Questions and Answers April 2015

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2010-D-0566
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

On July 1, 2008, the United States Pharmacopeia (USP) implemented a requirement for the control of residual solvents in drug products marketed in the United States. Once implemented, the requirement, USP General Chapter <467> Residual Solvents, became a statutory requirement under section 501(b) of the Federal Food, Drug, and Cosmetic Act.

The USP General Chapter <467> Residual Solvents applies to both human and veterinary drugs and to compendial and non-compendial drug products. Because the drug products CVM regulates are administered to a number of different animal species, CVM allows for a flexible approach to the implementation of USP <467> Residual Solvents. This document answers questions regarding CVM’s implementation of USP <467> Residual Solvents.

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