Source: https://www.law.cornell.edu/cfr/text/21/part-211/subpart-C
Timestamp: 2018-01-21 16:58:00
Document Index: 305033731

Matched Legal Cases: ['art 211', 'art 211', 'art 211', 'art 211', 'arts 201', '§ 211']

21 CFR Part 211, Subpart C - Buildings and Facilities | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter C › Part 211 › Subpart C
21 CFR Part 211, Subpart C - Buildings and Facilities
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 211 after this date.
81 FR 81685 - Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements
FR Doc. 2016-27838
RIN 0910-AC53
Docket No. FDA-2005-N-0343
This rule is effective January 17, 2017. See section V of this document for the compliance date of this final rule.
21 CFR Parts 201 and 211
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.
77 FR 16158 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls
FR Doc. 2012-6502
Docket No. FDA-1997-N-0518
This final rule is effective on March 20, 2013, except for the amendment adding § 211.122(g)(4), which is effective April 19, 2012.