United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2018-02-14 article Rules and Regulations D09002ee1c7f32ec3 D09002ee1c7f32f61 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 81 FR 81685 https://www.govinfo.gov/app/details/FR-2016-11-18/2016-27838 2016-27838 fr18no16-6 RIN 0910-AC53 4164-01-P Docket No. FDA-2005-N-0343 https://www.govinfo.gov/app/details/FR-2016-11-18/2016-27838 https://www.govinfo.gov/content/pkg/FR-2016-11-18/html/2016-27838.htm https://www.govinfo.gov/content/pkg/FR-2016-11-18/pdf/2016-27838.pdf Drugs Labeling Reporting and Recordkeeping Requirements Laboratories Packaging and Containers Prescription Drugs Warehouses 13 p. 81685 81697 81 FR 81685 Title 21 Part 201 21 CFR Part 201 Title 21 Part 211 21 CFR Part 211 RIN 0910-AC53 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements; Federal Register Vol. 81, Issue RULE 2016-27838 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2017-01-17 Docket No. FDA-2005-N-0343 4164-01-P 2016-27838 Final rule.

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.

This rule is effective January 17, 2017. See section V of this document for the compliance date of this final rule. J. Patrick Raulerson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6260, Silver Spring, MD 20993-0002, 301- 796-3522. Drugs Labeling Reporting and Recordkeeping Requirements Laboratories Packaging and Containers Prescription Drugs Warehouses Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements , http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm http://www.regulations.gov Vol. 81, no. 223 Office of the Federal Register, National Archives and Records Administration 2016-11-18 continuing daily deposited born digital 1471 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-11-18 P0b002ee1986804d6 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr18no16 https://www.govinfo.gov/app/details/FR-2016-11-18 https://www.govinfo.gov/content/pkg/FR-2016-11-18/pdf/FR-2016-11-18.pdf https://www.govinfo.gov/content/pkg/FR-2016-11-18/xml/FR-2016-11-18.xml fdlp 81641 83105 DGPO 2018-02-14 2024-06-01 FR-2016-11-18 machine generated eng FR FR-2016-11-18 81 223