[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