E9-28247. Guidance for Industry on Residual Solvents in Drug Products Marketed in the United States; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Residual Solvents in Drug Products Marketed in the United States.” On July 1, 2008, the United States Pharmacopeia (USP) published a new test requirement for the control of residual solvents, General Chapter <467> “Residual Solvents,” which replaced USP General Chapter <467> “Organic Volatile Impurities.” The change affects all compendial drug products marketed in the United States. This guidance reflects FDA's recommendations on how to comply with those USP changes.

DATES:

Submit written or electronic comments on agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of the guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov . See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

Chris Watts, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4142 Silver Spring, MD 20993-0002, 301-796-1625.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry entitled “Residual Solvents in Drug Products Marketed in the United States.” On August 7, 2008 (73 FR 46020), FDA announced the availability of the draft version of this guidance. The public comment period closed on October 6, 2008. A number of comments were received, which the agency considered carefully as it finalized the guidance. In response to the comments, FDA made appropriate changes. The guidance provides information on how new drug application (NDA) and abbreviated new drug application (ANDA) applicants for noncompendial drug products should limit residual solvents as described in the International Conference on Harmonisation guidance for industry “Q3C Impurities: Residual Solvents;” how manufacturers of compendial drug products that are not marketed under an approved NDA or ANDA can comply with the new General Chapter <467> and the Federal Food, Drug, and Cosmetic Act; and how holders of NDAs or ANDAs for compendial drug products should report changes in chemistry, manufacturing, and controls specifications to FDA to comply with the USP General Chapter <467> “Residual Solvents” and § 314.70 (21 CFR 314.70).

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on USP General Chapter <467> “Residual Solvents.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Information submitted in the chemistry, manufacturing, and controls section of an application under 21 CFR 314.50(d)(1), as well as in amendments to pending applications under 21 CFR 314.60, is approved by OMB under Control Number 0910-0001. Information submitted in an annual report under § 314.70(d)(2)(i) and (d)(3) is approved by OMB under Control Number 0910-0001. Recordkeeping required under 21 CFR 211.165(e) and 211.194(a)(2) is approved by OMB under Control Number 0910-0139.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm or http://www.regulations.gov.

Dated: November 19, 2009.

David Horowitz,

Assistant Commissioner for Policy.