[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Draft Guidance for Industry on Residual Solvents in Drug Products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availability of a draft guidance for industry entitled ``Control of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 This draft guidance reflects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this draft guidance before it begins work on the final version of the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written or electronic comments on the draft guidance by October 6,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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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 Submit written comments on the draft guidance to the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INFORMATION section for electronic access to the draft guidance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FDA is announcing the availability of a draft guidance for industry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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