Issue Date: April 3, 2015
Issued by: Center for Veterinary Medicine
Topic(s): Chemistry, Manufacturing, and Controls (CMC)
Status: Final
CVM GFI #211 Residual Solvents in Animal Drug Products Questions and Answers
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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