{"abstract":"The Food and Drug Administration (FDA or the Agency) is amending its current good manufacturing practice (CGMP) and labeling regulations regarding medical gases. FDA is requiring that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. FDA is also requiring that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and color requirements. These requirements are intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container. FDA is also revising an existing regulation that conditionally exempts certain medical gases from certain otherwise-applicable labeling requirements in order to add oxygen and nitrogen to the list of gases subject to the exemption, and to remove cyclopropane and ethylene from the list.","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/2016/11/18/2016-27838.html","cfr_references":[{"chapter":null,"citation_url":null,"part":201,"title":21},{"chapter":null,"citation_url":null,"part":211,"title":21}],"citation":"81 FR 81685","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective January 17, 2017. See section V of this document for the compliance date of this final rule.","disposition_notes":null,"docket_ids":["Docket No. FDA-2005-N-0343"],"dockets":[],"document_number":"2016-27838","effective_on":"2017-01-17","end_page":81697,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/11/18/2016-27838.xml","html_url":"https://www.federalregister.gov/documents/2016/11/18/2016-27838/medical-gas-containers-and-closures-current-good-manufacturing-practice-requirements","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-27838?publication_date=2016-11-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-11-18/2016-27838/mods.xml","not_received_for_publication":null,"page_length":13,"page_views":{"count":2772,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-11-18/pdf/2016-27838.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-27838.pdf?1479390405","publication_date":"2016-11-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/11/18/2016-27838.txt","regulation_id_number_info":{"0910-AC53":{"issue":"201610","html_url":"https://www.federalregister.gov/regulations/0910-AC53/medical-gas-containers-and-closures-current-good-manufacturing-practice-requirements","title":"Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201610&RIN=0910-AC53&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AC53"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 3 - Safety Bulletin SB-26, Cylinder Connections on Portable Liquid Cryogenic Cylinders","document_id":"FDA-2005-N-0343-0041"},{"title":"Reference 2 - Standard Color Marking of Compressed Gas Containers for Medical Use","document_id":"FDA-2005-N-0343-0040"},{"title":"Reference 1 - Standard for Appropriate and Effective Regulations for Medical Gases within 21 CFR Parts 201, 2015, and 210 211","document_id":"FDA-2005-N-0343-0039"},{"title":"Reference list","document_id":"FDA-2005-N-0343-0038"},{"title":"Envelope re Comment from Florida Department of Health","document_id":"FDA-2005-N-0343-0015"},{"title":"Tab 1(A) 21 CFR 211.25(a);","document_id":"FDA-2005-N-0343-0013"},{"title":"References re Proposed rule on Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements, docket No. 2005N-0437 (71 FR 18039, April 10,2006)","document_id":"FDA-2005-N-0343-0012"},{"title":"Background Material","document_id":"FDA-2005-N-0343-0011"},{"title":"Tab 11 Viscusi, W.K., Fatal Tradeoffs, Public and Private Responsibilities for Risk, Oxford University Press, 1992.","document_id":"FDA-2005-N-0343-0010"},{"title":"Tab 9 NFPA 99; Standard for Health Care Facilities (2005 edition)","document_id":"FDA-2005-N-0343-0009"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2005-N-0343","supporting_documents_count":17,"docket_id":"FDA-2005-N-0343","regulation_id_number":null,"title":"Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements","checked_regulationsdotgov_at":"2016-12-08T06:00:18Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":81685,"subtype":null,"title":"Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements","toc_doc":"Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements","toc_subject":null,"topics":["Drugs","Labeling","Laboratories","Packaging and containers","Prescription drugs","Reporting and recordkeeping requirements","Warehouses"],"type":"Rule","volume":81}