[Federal Register Volume 74, Number 226 (Wednesday, November 25, 2009)]
[Notices]
[Pages 61692-61693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28247]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0413]


Guidance for Industry on Residual Solvents in Drug Products 
Marketed in the United States; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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:

[[Page 61693]]

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 
Sec.  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 Sec.  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.
[FR Doc. E9-28247 Filed 11-24-09; 8:45 am]
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