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Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2010-D-0566.