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GUIDANCE DOCUMENT

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

Final

Residual Solvents in Drug Products Marketed in the United States

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


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.