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HHS/FDA RIN: 0910-AC53 Publication ID: Fall 2004 
Title: Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements 
Abstract: The Food and Drug Administration is proposing to amend its current good manufacturing practice regulations and other regulations to clarify and strengthen requirements for the label, color, dedication, and design of medical gas containers and closures. Despite existing regulatory requirements and industry standards for medical gases, there have been repeated incidents in which cryogenic containers of harmful industrial gases have been connected to medical oxygen supply systems in hospitals and nursing homes, and subsequently administered to patients. These incidents have resulted in death and serious injury. There have also been several incidents involving high-pressure medical gas cylinders that have resulted in death and injuries to patients. These proposed amendments, together with existing regulations, are intended to ensure that the types of incidents that have occurred in the past, as well as other types of foreseeable and potentially deadly medical gas mixups, do not occur in the future. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 201.161(a); 21 CFR 210.3(b); 21 CFR 211.94 
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 353 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  06/00/2005   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Elaine H. Tseng
Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7),
Rockville, MD 20852
Phone:301 594-2041
Fax:301 827-5562
Email: elaine.tseng@fda.hhs.gov

 
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