2011-5948. Draft Guidance for Industry on Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework.” This guidance describes the importance of implementing appropriate steps during the manufacturing process to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactam antibiotics. The draft guidance is intended to assist manufacturers in assessing whether separate facilities should be used based on the relative health risk of cross-reactivity.

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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 16, 2011.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm.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 request. The guidance may also be obtained by mail by calling CDER at 301-796-3400. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit electronic comments concerning the draft guidance to http://www.regulations.gov.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. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Edwin Melendez, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4370, Silver Spring, MD 20993-0002, 301-796-3284.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework.” This draft guidance describes the importance of implementing appropriate steps during the manufacturing process to prevent cross-contamination of finished pharmaceuticals and APIs with non-penicillin beta-lactam antibiotics. It also provides information regarding the relative health risk of, and the potential for, cross-reactivity in the classes of sensitizing beta-lactams (penicillins and non-penicillin beta-lactams).

Drug cross-contamination is the contamination of one drug with one or more different drugs. Cross-contamination with non-penicillin beta-lactam drugs can initiate drug-induced hypersensitivity reactions, including anaphylaxis, an allergic reaction that may be a life-threatening event. One critical aspect of manufacturing non-penicillin beta-lactam drugs is preventing cross-contamination to reduce the potential for drug-induced, life-threatening allergic reactions. FDA is recommending that manufacturers establish appropriate separation and control systems designed to prevent the following types of cross-contamination: (1) Non-penicillin beta-lactam contamination in a non-beta-lactam product (e.g., cefaclor in aspirin) and (2) non-penicillin beta-lactam contamination in another non-penicillin beta-lactam (e.g., cephalexin in imipenem).

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 non-penicillin beta-lactam risk assessment. 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 statute 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: March 9, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.