2010-29896. Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 This guidance updates recommendations regarding degradation products and updates the draft guidance “ANDAs: Impurities in Drug Products” announced in December 1998 in conformance with the revision of the International Conference on Harmonisation (ICH)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 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 In December 1998, FDA issued the draft guidance “ANDAs: Impurities in Drug Products,” and in August 2005, FDA revised it in conformance with the “Q3B(R) Impurities in New Drug Products” guidance for industry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in conformance with the revision of the guidance for industry on Q3B(R) and (2) remove those sections of the 1998 draft guidance containing recommendations that are no longer needed because they are addressed in the more recent Q3B(R).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.