[Federal Register Volume 75, Number 228 (Monday, November 29, 2010)]
[Notices]
[Pages 73108-73109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29896]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0584]


Guidance for Industry on Abbreviated New Drug Applications: 
Impurities in Drug Products; 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 ``ANDAs: Impurities in 
Drug Products.'' This guidance updates recommendations regarding 
degradation products and updates the draft guidance ``ANDAs: Impurities 
in Drug Products'' announced in December 1998 in conformance with the 
revision of the International Conference on Harmonisation (ICH) 
guidance for industry ``Q3B(R) Impurities in New Drug Products,'' which 
was announced in August 2006.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New

[[Page 73109]]

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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Devinder Gill, Center for Drug 
Evaluation and Research (HFD-630), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8483.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``ANDAs: Impurities in Drug Products.'' In December 1998, FDA 
issued the draft guidance ``ANDAs: Impurities in Drug Products,'' and 
in August 2005, FDA revised it in conformance with the ``Q3B(R) 
Impurities in New Drug Products'' guidance for industry that was 
announced in August 2006.
    We are issuing the final guidance to: (1) Update information on 
listing of degradation products, setting acceptance criteria, and 
qualifying degradation products (thresholds and procedures) in 
abbreviated new drug applications (ANDAs) in conformance with the 
revision of the guidance for industry on Q3B(R) and (2) remove those 
sections of the 1998 draft guidance containing recommendations that are 
no longer needed because they are addressed in the more recent Q3B(R). 
The Q3B(R) was developed by the ICH to provide guidance on impurities 
in drug products for new drug applications (NDAs). However, the Agency 
believes that many of the recommendations provided on impurities in 
NDAs also apply to ANDAs.
    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 impurities in drug products submitted as 
ANDAs. 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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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.

III. 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 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29896 Filed 11-26-10; 8:45 am]
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