View Rule
| Printer-Friendly Version Download RIN Data in XML |
| HHS/FDA | RIN: 0910-AC53 | Publication ID: Spring 2003 |
| Title: ●Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements | |
| Abstract: The Food and Drug Administration (FDA) is proposing to amend its current good manufacturing practice (CGMP) 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: First time 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:
|
| Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: None |
| Federalism: No | |
| Included in the Regulatory Plan: No | |
|
Agency Contact: Howard P. Muller Office of Regulatory Policy Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-3601 Fax:301 847-8440 Email: howard.mullerjr@fda.hhs.gov |
|
