[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Notices]
[Pages 22887-22888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08913]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A 
Current Good Manufacturing Practices Framework for Preventing Cross-
Contamination; 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 ``Non-Penicillin Beta-
Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.'' 
This guidance describes the importance of implementing controls to 
prevent cross-contamination of finished pharmaceuticals and active 
pharmaceutical ingredients (APIs) with non-penicillin beta-lactams. 
This guidance also provides information regarding the relative health 
risk of, and the potential for, cross-reactivity in the classes of 
sensitizing beta-lactams (including both penicillins and non-penicillin 
beta-lactams), beta-lactamase inhibitors, and beta-lactam intermediates 
and derivatives. Finally, this guidance clarifies that manufacturers 
should generally utilize separate facilities for manufacture of non-
penicillin beta-lactams because those compounds pose health risks 
associated with cross-reactivity.

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: Paula Katz, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, rm. 4314, Silver Spring, MD 20993-0002, 301-796-6972.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for 
Preventing Cross-Contamination.'' This guidance describes the 
importance of implementing controls to prevent cross-contamination of 
finished pharmaceuticals and APIs with non-penicillin beta-lactam 
drugs. This guidance also provides information regarding the relative 
health risk of, and the potential for, cross-reactivity in the classes 
of sensitizing beta-lactams (including both penicillins and non-
penicillin beta-lactams). Finally, this guidance clarifies that 
manufacturers should generally utilize separate facilities for 
manufacture of non-penicillin beta-lactams because those compounds pose 
health risks associated with cross-reactivity.
    Although the existing current good manufacturing practices (CGMP) 
regulations require separation of manufacturing facilities to avoid 
cross-contamination, the only class of products for which the 
regulations specify particular separation

[[Page 22888]]

requirements are penicillins. This guidance explains that, due to the 
potential health risks of cross-contamination, the Agency expects 
separation for all classes of beta-lactam drugs, including penicillins 
as well as non-penicillin beta-lactams. Specifically, FDA recommends 
that manufacturers establish appropriate separation and control systems 
designed to prevent two types of contamination: (1) The contamination 
of a non-penicillin beta-lactam by any other non-penicillin beta-lactam 
and (2) the contamination of any other type of product by a non-
penicillin beta-lactam. Accordingly, FDA recommends that the area in 
which any class of sensitizing beta-lactam is manufactured should be 
separated from areas in which any other products are manufactured, and 
should have an independent air handling system.
    A draft version of this guidance was published in March 2011 as 
``Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework.'' This 
final version was revised in response to docket comments to clarify 
that this guidance does not provide a formal risk assessment, but, 
rather, describes FDA's expectations and recommendations for separation 
strategies to prevent cross-contamination.
    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 Non-Penicillin Beta-Lactam Drugs: A CGMP 
Framework for Preventing Cross-Contamination. 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.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: April 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08913 Filed 4-16-13; 8:45 am]
BILLING CODE 4160-01-P