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 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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.