Notice2025-21689
Medical Gases-Current Good Manufacturing Practice; Draft Guidance for Industry; Availability
Primary source
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Published
December 1, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Medical Gases--Current Good Manufacturing Practice." This guidance is intended to assist manufacturers of medical gases in complying with regulations for current good manufacturing practice (CGMP) that become effective on December 18, 2025 (note, the conforming amendments to the CGMP requirements for combination products became effective February 2, 2026). These regulations are specific to medical gases for human and animal use and, like all CGMP requirements, contain the minimum requirements to ensure that manufacturing processes operate under a state of control to meet prespecified quality standards for identity, strength, quality, and purity, but are tailored more narrowly to how medical gases are manufactured, packaged, labeled, stored, and distributed. This draft guidance is being issued to reflect new and revised regulations in several areas to reduce the regulatory burden, as appropriate, for the medical gas industry. This draft guidance revises and replaces the draft guidance entitled "Current Good Manufacturing Practice for Medical Gases" issued in June 2017.
Full Text
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<title>Federal Register, Volume 90 Issue 228 (Monday, December 1, 2025)</title>
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[Federal Register Volume 90, Number 228 (Monday, December 1, 2025)]
[Notices]
[Pages 55131-55133]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-21689]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2003-D-0431]
Medical Gases--Current Good Manufacturing Practice; Draft
Guidance for Industry; Availability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, Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Medical Gases--Current Good Manufacturing Practice.'' This guidance
is intended to assist manufacturers of medical gases in complying with
regulations for current good manufacturing practice (CGMP) that become
effective on December 18, 2025 (note, the conforming amendments to the
CGMP requirements for combination products became effective February 2,
2026). These regulations are
[[Page 55132]]
specific to medical gases for human and animal use and, like all CGMP
requirements, contain the minimum requirements to ensure that
manufacturing processes operate under a state of control to meet
prespecified quality standards for identity, strength, quality, and
purity, but are tailored more narrowly to how medical gases are
manufactured, packaged, labeled, stored, and distributed. This draft
guidance is being issued to reflect new and revised regulations in
several areas to reduce the regulatory burden, as appropriate, for the
medical gas industry. This draft guidance revises and replaces the
draft guidance entitled ``Current Good Manufacturing Practice for
Medical Gases'' issued in June 2017.
DATES: Submit either electronic or written comments on the draft
guidance by January 30, 2026 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-2003-D-0431 for ``Medical Gases--Current Good Manufacturing
Practice.'' 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 or Policy
and Regulations Staff, Center for Veterinary Medicine, Food and Drug
Administration, 5001 Campus Drive, College Park, MD 20740. 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: Ashley Boam, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4192, Silver Spring, MD 20993-0002, 301-
796-6341 or Scott Fontana, Center for Veterinary Medicine, Food and
Drug Administration, 5001 Campus Drive, College Park, MD 20740, 240-
402-0656.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Medical Gases--Current Good Manufacturing Practice.'' This
guidance revises and replaces the draft guidance issued on June 29,
2017, entitled ``Current Good Manufacturing Practice for Medical
Gases'' (82 FR 29565), which described how medical gas manufacturers
could comply with applicable requirements in the general drug CGMP
regulations under parts 210 and 211 (21 CFR parts 210 and 211).
``Medical gas'' is defined in section 575(2) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360ddd(2)) as a drug that
is manufactured or stored in a liquefied, nonliquefied, or cryogenic
state and administered as a gas. Medical gases include ``designated
medical gases'' (DMGs) as defined in section 575(1) of the FD&C Act;
medically appropriate combinations of DMGs; medical gases marketed
under applications submitted under sections 505 (21 U.S.C. 355) or 512
(21 U.S.C. 360b) of the FD&C Act; and any marketed unapproved drugs
that are medical gases.
On June 18, 2024, FDA issued a final rule (89 FR 51738) that
established requirements more specifically tailored to medical gases to
better address the unique characteristics of these drugs. The final
rule was intended to reduce the regulatory burden, as appropriate, for
the medical gas industry. This deregulatory effort addressed several
areas in which either new regulations
[[Page 55133]]
were needed, or existing regulations required revision because they
were not well-suited for medical gases. One area where new regulations
were established was CGMP.
Prior to implementation of the final rule, medical gas
manufacturers were subject to the general drug CGMP regulations for
finished pharmaceutical under parts 210 and 211, but these regulations
did not account for differences in how medical gases are manufactured
compared to other drugs. Notably, medical gases are generally
manufactured in a closed, sealed pressurized system; are not expected
to expire or degrade under ordinary storage conditions; and are
contained in cylinders that are reused many times. In addition, medical
gas manufacturing involves entities downstream of the original gas
manufacturer who further manufacture, process, pack, or hold medical
gases. Mix-ups or the accidental use of rejected or quarantined product
generally pose more of a risk to patient safety than does
contamination.
Because of these differences, certain requirements in the general
CGMP regulations under parts 210 and 211 were unnecessary to assure the
safety, identity, strength, quality, and purity of medical gases (e.g.,
distributing oldest stock first, use of filters, and certain
requirements for controlling microbial contamination). FDA addressed
these differences in the June 2017 draft guidance for industry.
However, those recommendations will no longer be applicable with
the implementation of the final rule. As of December 18, 2025, medical
gas manufacturers are subject to medical gas-specific CGMP regulations
under part 213 (21 CFR part 213) rather than the general CGMP
regulations under parts 210 and 211 (note, conforming amendments to
CGMP regulations for combination products are effective February 2,
2026). The guidance announced in this notice explains how medical gas
manufacturers can comply with part 213, and includes among its
recommendations clarification on the following:
<bullet> Ensuring the reliability of a supplier's capabilities
<bullet> Protecting against container closure leaks
<bullet> Appropriate cleaning and maintenance of buildings, facilities,
and equipment used in medical gas manufacture
<bullet> Prevention of labeling and product mix-ups
<bullet> Circumstances requiring stability testing, expiration testing,
or both
<bullet> Handling of returned and salvaged medical gases
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 current thinking of FDA on ``Medical
Gases--Current Good Manufacturing Practice.'' 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.
As we develop final guidance on this topic, FDA will consider
comments on costs or cost savings the guidance may generate, relevant
for Executive Order 14192.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 11 relating to electronic records and electronic
signatures have been approved under OMB control number 0910-0303. The
collections of information in 21 CFR part 213 relating to current good
manufacturing practice requirements for medical gases, including 21 CFR
213.22(d), which states that quality unit activities (such as quality
agreements with suppliers) and procedures should be in writing, have
been approved under OMB control number 0910-0906.
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>.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-21689 Filed 11-28-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on December 1, 2025.
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