{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule revising the requirements concerning current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling that apply to certain medical gases. This final rule also establishes regulations regarding certification of designated medical gases. This final rule satisfies the medical gas rulemaking requirements of the Consolidated Appropriations Act, 2017.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2024/06/18/2024-13190.html","cfr_references":[{"chapter":null,"citation_url":null,"part":4,"title":21},{"chapter":null,"citation_url":null,"part":16,"title":21},{"chapter":null,"citation_url":null,"part":201,"title":21},{"chapter":null,"citation_url":null,"part":210,"title":21},{"chapter":null,"citation_url":null,"part":211,"title":21},{"chapter":null,"citation_url":null,"part":213,"title":21},{"chapter":null,"citation_url":null,"part":230,"title":21},{"chapter":null,"citation_url":null,"part":314,"title":21},{"chapter":null,"citation_url":null,"part":514,"title":21}],"citation":"89 FR 51738","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective December 18, 2025, except for the amendments to Sec. Sec. 4.2 (amendatory instruction 2), 4.3 (amendatory instruction 3), and 4.4 (amendatory instruction 4) (21 CFR 4.2, 4.3, and 4.4), which are effective February 2, 2026. The incorporation by reference of certain material listed in this rule has been approved by the Director of the Federal Register as of February 2, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-1333"],"dockets":[{"supporting_documents":[{"title":"Reference 6--FRIA Medical Gases","document_id":"FDA-2021-N-1333-0031"},{"title":"Reference 5--Postmarketing Safety Reporting Draft Guidance","document_id":"FDA-2021-N-1333-0030"},{"title":"Reference 4--Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application","document_id":"FDA-2021-N-1333-0029"},{"title":"Reference 3--Medical Gas CPGM","document_id":"FDA-2021-N-1333-0028"},{"title":"Reference 2--Med Gas - Container Closure - OMQ White Paper","document_id":"FDA-2021-N-1333-0027"},{"title":"Reference 1--Certification Process Draft Guidance","document_id":"FDA-2021-N-1333-0026"},{"title":"Reference18 -Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases","document_id":"FDA-2021-N-1333-0020"},{"title":"Reference18-Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases","document_id":"FDA-2021-N-1333-0018"},{"title":"Reference 17-Veterinary Adverse Event Reporting for Manufacturers","document_id":"FDA-2021-N-1333-0017"},{"title":"Reference 16- Medical Dictionary for Regulatory Activities","document_id":"FDA-2021-N-1333-0016"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-06-18","updated_at":"2024-09-03T17:06:45.671-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-N-1333-0025","allow_late_comments":false,"id":"FDA-2021-N-1333-0025","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":25,"id":"FDA-2021-N-1333","title":"Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases"}],"document_number":"2024-13190","effective_on":"2025-12-18","end_page":51783,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/06/18/2024-13190.xml","html_url":"https://www.federalregister.gov/documents/2024/06/18/2024-13190/current-good-manufacturing-practice-certification-postmarketing-safety-reporting-and-labeling","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-13190?publication_date=2024-06-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-06-18/2024-13190/mods.xml","not_received_for_publication":null,"page_length":46,"page_views":{"count":11227,"last_updated":"2026-04-05 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-18/pdf/2024-13190.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-13190.pdf?1718628314","publication_date":"2024-06-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/06/18/2024-13190.txt","regulation_id_number_info":{"0910-AH96":{"issue":"202204","html_url":"https://www.federalregister.gov/regulations/0910-AH96/updated-regulations-for-medical-gases","title":"Updated Regulations for Medical Gases","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202204&RIN=0910-AH96&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AH96"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 6--FRIA Medical Gases","document_id":"FDA-2021-N-1333-0031"},{"title":"Reference 5--Postmarketing Safety Reporting Draft Guidance","document_id":"FDA-2021-N-1333-0030"},{"title":"Reference 4--Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application","document_id":"FDA-2021-N-1333-0029"},{"title":"Reference 3--Medical Gas CPGM","document_id":"FDA-2021-N-1333-0028"},{"title":"Reference 2--Med Gas - Container Closure - OMQ White Paper","document_id":"FDA-2021-N-1333-0027"},{"title":"Reference 1--Certification Process Draft Guidance","document_id":"FDA-2021-N-1333-0026"},{"title":"Reference18 -Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases","document_id":"FDA-2021-N-1333-0020"},{"title":"Reference18-Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases","document_id":"FDA-2021-N-1333-0018"},{"title":"Reference 17-Veterinary Adverse Event Reporting for Manufacturers","document_id":"FDA-2021-N-1333-0017"},{"title":"Reference 16- Medical Dictionary for Regulatory Activities","document_id":"FDA-2021-N-1333-0016"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2021-N-1333","supporting_documents_count":25,"docket_id":"FDA-2021-N-1333","document_id":"FDA-2021-N-1333-0025","regulation_id_number":null,"title":"Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases","checked_regulationsdotgov_at":"2024-06-21T12:00:12Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":51738,"subtype":null,"title":"Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases","toc_doc":"Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases","toc_subject":null,"topics":["Administrative practice and procedure","Animal drugs","Biologics","Confidential business information","Drugs","Human cells and tissue-based products","Incorporation by reference","Labeling","Laboratories","Medical devices","Packaging and containers","Prescription drugs","Reporting and recordkeeping requirements","Warehouses"],"type":"Rule","volume":89}