[Federal Register Volume 73, Number 153 (Thursday, August 7, 2008)]
[Notices]
[Pages 46020-46021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18127]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Residual Solvents in Drug Products 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availability of a draft guidance for industry entitled ``Control of 
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 This draft guidance reflects 
FDA's recommendations on how to comply with those USP changes.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit

[[Page 46021]]

written or electronic comments on the draft guidance by October 6, 
2008.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 Submit written comments on the draft guidance to the 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INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Larry Ouderkirk, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 4125, Silver Spring, MD 20993, 301-796-
1585.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Residual Solvents in Drug Products Marketed in the United 
States.'' Beginning July 1, 2008, FDA will require that drug products 
marketed in the United States with an official USP monograph meet the 
residual solvents requirements in the revised General Chapter <467> 
``Residual Solvents.''
    For compendial drug products approved under a new drug application 
(NDA) or abbreviated new drug application (ANDA), changes made to the 
specifications in the approved application regarding the revised 
General Chapter <467> should be in accordance with applicable 
regulations described in 21 CFR 314.70 and the recommendations in the 
guidance for industry on ``Changes to an Approved NDA or ANDA, April 
2004.'' FDA expects that in most cases, an annual report can be used to 
report changes.
    FDA recommends that applicants who have submitted NDAs or ANDAs to 
the agency for drug products that are not the subject of an official 
USP monograph control and limit the presence of residual solvents in 
the subject drug product as described in the guidance on ``Q3C 
Impurities: Residual Solvents.''
    Marketed compendial drug products that are not approved under an 
NDA or ANDA (for example, over-the-counter (OTC) drug products that are 
marketed under an FDA OTC monograph) are also subject to the provisions 
of the Federal Food, Drug, and Cosmetic Act, the revised General 
Chapter <467>, and current good manufacturing practice requirements in 
21 CFR 211.165(e) and 211.194(a)(2).
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on control of 
residual solvents in drug products marketed in the United States. 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. 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.regulations.gov.

    Dated: July 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-18127 Filed 8-6-08; 8:45 am]
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