Medical Gases-Current Good Manufacturing Practice; Draft Guidance for Industry; Availability

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2003-D-0431]</DEPDOC> <SUBJECT>Medical Gases—Current Good Manufacturing Practice; Draft Guidance for Industry; Availability</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice of availability. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Medical Gases—Current Good Manufacturing Practice.”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 This draft guidance is being issued to reflect new and revised regulations in several areas to reduce the regulatory burden, as appropriate, for the medical gas industry. This draft guidance revises and replaces the draft guidance entitled “Current Good Manufacturing Practice for Medical Gases” issued in June 2017. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Submit either electronic or written comments on the draft guidance by January 30, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments on any guidance at any time as follows: <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> 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 <E T="03">https://www.regulations.gov.</E> • 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”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • 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.” <E T="03">Instructions:</E> 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 <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • 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 <E T="03">https://www.regulations.gov.</E> 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: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> 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 <E T="02">SUPPLEMENTARY INFORMATION</E> section for electronic access to the draft guidance document. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> 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 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 T="03">e.g.,</E> 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 recommendation ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 13k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━