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GUIDANCE DOCUMENT

Residual Solvents in Drug Products Marketed in the United States Guidance for Industry November 2009

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2008-D-0413
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist manufacturers in responding to the issuance of the United States Pharmacopeia (USP) requirement; for the control of residual solvents in drug products marketed in the United States. Specifically, this guidance makes recommendations on the following

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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:

Dockets Management
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-2008-D-0413.

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