Document ID: FDA-2011-D-0104-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry; Availability: Non-Penicillin Beta-Lactam Risk Assessment, A CGMP Framework
Posted Date: 2011-03-15T04:00Z

[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Notices]
[Page 14024]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5948]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0104]

Draft Guidance for Industry on Non-Penicillin Beta-Lactam Risk 
Assessment: A CGMP Framework; 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availability of a draft guidance for industry entitled ``Non-Penicillin 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 The draft guidance is intended to 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 16, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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    Submit electronic comments concerning the draft guidance to http://www.regulations.gov.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.
[FR Doc. 2011-5948 Filed 3-14-11; 8:45 am]
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