[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Notices]
[Pages 37231-37232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-14674]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0938]


Guidance for Industry; Guidance on Abbreviated New Drug 
Applications: Stability Testing of Drug Substances and Products; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance entitled ``ANDAs: Stability Testing of 
Drug Substances and Products.'' FDA is recommending generic drug 
manufacturers follow the stability testing recommendations in the 
International Conference on Harmonisation (ICH) guidances Q1A (R2) 
through Q1E. The use of these ICH recommendations will standardize 
FDA's stability testing policies, which will help make the abbreviated 
new drug application (ANDA) review process more efficient.

DATES: Submit either electronic or written 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 the 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: Radhika Rajagopalan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 7500 Standish 
Pl., MPN2, rm. 243, HFD-640, Rockville, MD 20855, 240-276-8546.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``ANDAs: Stability Testing of Drug Substances and Products.'' 
Because of increases in the number and complexity of ANDAs and FDA's 
desire to standardize generic drug review, FDA is recommending that the 
generic drug industry follow the approach in the following stability 
related ICH guidances: (1) ``Q1A (R2) Stability Testing of New Drug 
Substances and Products,'' November 2003; (2) ``Q1B Photostability 
Testing of New Drug Substances and Products,'' November 1996; (3) ``Q1C 
Stability Testing for New Dosage Forms,'' November 1996; (4) ``Q1D 
Bracketing and Matrixing Designs for Stability Testing of New Drug 
Substances and Products,'' January 2003; and (5) ``Q1E Evaluation of 
Stability Data,'' June 2004. These guidances can be found on the FDA 
Guidances (Drugs) Web site under International Conference on 
Harmonisation--Quality at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065005.htm. FDA 
also recommends that industry follow the ICH outlined definitions, 
glossaries, references, and attachments.
    Although the ICH stability guidances were developed for new drug 
applications to ensure the stability of new drug substances and 
products, FDA believes the recommendations provided in the ICH 
guidances on stability testing also are appropriate for ANDAs. FDA is 
recommending that applicants follow the ICH stability guidances for all 
ANDA submissions under section 505(j) of the Federal Food Drug, and 
Cosmetic Act (21 U.S.C. 355(j)) and relying on drug master files.
    This guidance also replaces stability study storage condition 
recommendations made by the Office of Generic Drugs (OGD) in an August 
18, 1995, letter to all ANDA applicants.

[[Page 37232]]

That letter stated that OGD would accept ANDAs with the ICH recommended 
long-term room temperature conditions for stability studies, 25  2[deg] C, 60  5 percent RH.
    On September 25, 2012 (77 FR 58999), FDA announced the availability 
of draft guidance for industry on ``ANDAs: Stability Testing of Drug 
Substances and Products.'' The public comment period closed on December 
24, 2012. We are finalizing the guidance with minor changes and intend 
to publish a draft guidance to address the public comments in a 
question-and-answer format in the near future.
    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 this stability testing for generic drug 
substances and products. 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 either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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 and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

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

    Dated: June 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14674 Filed 6-19-13; 8:45 am]
BILLING CODE 4160-01-P