Notice2022-13513
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination; Draft Guidance for Industry; Availability
Primary source
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Published
June 24, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Non- Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross- Contamination." This draft guidance describes methods, facility design elements, and controls that are important in preventing drugs from being cross-contaminated with non-penicillin beta-lactam antibacterial drugs or non-antibacterial beta-lactam compounds, and it makes recommendations for how manufacturers can be compliant with current good manufacturing practice requirements for preventing cross- contamination. This draft guidance also provides information regarding the relative health risk of, and the potential for, cross-reactivity in the classes of non-penicillin beta-lactam antibacterial drugs and non- antibacterial beta-lactam compounds. This draft guidance revises the guidance of the same title issued on April 17, 2013.
Full Text
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<title>Federal Register, Volume 87 Issue 121 (Friday, June 24, 2022)</title>
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[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Notices]
[Pages 37870-37871]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13513]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0104]
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing
Cross-Contamination; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Non-
Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-
Contamination.'' This draft guidance describes methods, facility design
elements, and controls that are important in preventing drugs from
being cross-contaminated with non-penicillin beta-lactam antibacterial
drugs or non-antibacterial beta-lactam compounds, and it makes
recommendations for how manufacturers can be compliant with current
good manufacturing practice requirements for preventing cross-
contamination. This draft guidance also provides information regarding
the relative health risk of, and the potential for, cross-reactivity in
the classes of non-penicillin beta-lactam antibacterial drugs and non-
antibacterial beta-lactam compounds. This draft guidance revises the
guidance of the same title issued on April 17, 2013.
DATES: Submit either electronic or written comments on the draft
guidance by August 23, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2011-D-0104 for ``Non-Penicillin Beta-Lactam Drugs: A CGMP
Framework for Preventing Cross-Contamination.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: Carla Lankford, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 6656, Silver Spring, MD 20993-0002, 301-
796-5203.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for
Preventing Cross-Contamination.'' This draft guidance describes
methods, facility design elements, and controls that are important in
preventing drugs from being cross-contaminated with non-penicillin
beta-lactam antibacterial drugs or non-antibacterial beta-lactam
compounds,\1\ and it makes recommendations for how
[[Page 37871]]
manufacturers can be compliant with current good manufacturing practice
(CGMP) requirements for preventing cross-contamination. This guidance
also provides information regarding the relative health risk of, and
the potential for, cross-reactivity in the classes of non-penicillin
beta-lactam antibacterial drugs and non-antibacterial beta-lactam
compounds. This guidance recommends that manufacturers should
manufacture non-penicillin beta-lactam antibacterial drugs with
complete and comprehensive separation from manufacturing operations of
other drugs. For manufacturers of non-antibacterial beta-lactam
compounds, this guidance provides recommendations on cross-
contamination prevention strategies, including examples of relevant
design features and control approaches for those seeking to justify a
cross-contamination prevention strategy other than complete and
comprehensive separation when appropriate.
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\1\ In the guidance, non-penicillin beta-lactam antibacterial
drug(s) refers to any drug that is not a penicillin, has a chemical
structure that includes one or more beta-lactam rings, and has an
antibacterial mechanism of action. Non-antibacterial beta-lactam
compound(s) refers to any compound, including an intermediate or
derivative, that is not a penicillin, has a chemical structure that
includes one or more beta-lactam rings, and has a mechanism of
action other than an antibacterial mechanism of action.
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This guidance revises the guidance of the same title issued on
April 17, 2013 (78 FR 22887). Significant changes from the 2013
guidance include:
<bullet> Clarifying that the scope of the guidance also includes
all compounds, including intermediates or derivatives, that are not a
penicillin, have a chemical structure that includes one or more beta-
lactam rings, and have a mechanism of action other than an
antibacterial mechanism of action;
<bullet> Providing FDA's interpretation of terms, such as allergic
reaction, cross-reactivity, and complete and comprehensive separation,
used in this guidance;
<bullet> Clarifying the distinction between non-penicillin beta-
lactam antibacterial drug(s) and non-antibacterial beta-lactam
compound(s)--in terms of the cross-contamination and patient exposure
risks and the control strategies appropriate for manufacturing
operations involving each category; and
<bullet> Providing recommendations for drug manufacturers that seek
to justify alternative cross-contamination prevention strategies for
non-antibacterial beta-lactam compounds.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will replace the 2013 guidance and represent the current
thinking of FDA on ``Non-Penicillin Beta-Lactam Drugs: A CGMP Framework
for Preventing Cross-Contamination.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. The Paperwork Reduction Act of 1995
FDA tentatively concludes that this draft guidance contains no new
collection of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3521) is not required. However, this draft
guidance refers to previously approved FDA collections of information.
These collections of information are subject to review by OMB under the
PRA. The collections of information in 21 CFR parts 210 and 211 have
been approved under OMB control number 0910-0139; and the collections
of information in 21 CFR part 314 have been approved under OMB control
number 0910-0001.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: June 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13513 Filed 6-23-22; 8:45 am]
BILLING CODE 4164-01-P
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