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Compressed Medical Gases
(Medical Gases Are Drugs, Too)
 

Guidance Documents:

  • April 10, 2006; Proposed Rule - Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. [TXT] [PDF]
  • Draft Guidance for Industry on the Current Good Manufacturing Practice for Medical Gases [Word] or [PDF] (Posted 5/6/2003)
  • Compressed Medical Gases Guideline, February 1989. [HTML] or [PDF] 
    This guideline describes practices and procedures for compressed medical gas (CMG) fillers (including companies engaged in home respiratory services) that constitute acceptable means of complying with certain sections of the current good manufacturing practice (CGMP) regulations for drug products (21 CFR Parts 210 and 211).
  • Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory.  [HTML] or [PDF] (Issued and Posted 4/5/2001) This guidance is intended to alert hospitals, nursing homes, and other health care facilities to the hazards of medical gas mix-ups.

Medical Gas Mix-Ups

  • Medical Gas Mix-Ups  This resource page provides links to medical gas safety educational products, medical gas mix-up alerts, and guidances and standards.    (Posted 11/20/2002)

Other Medical Gas Information:

  • Oxygen Bars: Is a Breath of Fresh Air Worth It?  Article from FDA Consumer magazine. (Posted 11/18/2002)

  • Fresh Air 2000 (Updated 3/8/2000)
    Fresh Air 2000 is the text of a presentation by FDA's Mr. Duane Sylvia , that contains current good manufacturing practice information for the manufacturing of medical gases. This document is intended to supplement the CGMPs by describing the agency's current thinking regarding practices and procedures that make filling of medical gases so unique.

  • Medical Gas Seizure Actions PDF (5/22/2001)
    Listing of seizure actions taken by the Agency for Fiscal Year 1993 to present
  • Medical Gas Warning Letters  (1/24/2003)
    Listing of warning letters issued from Fiscal Year 1993 to the present. If you do not see a particular warning letter, it may not have been received by CDER Office of Compliance for inclusion on the list.

  • Batch Production Record PDF (3/8/99)  This is an example of a batch production record for filling high pressure cylinders.

 

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Last Updated: June 28, 2006
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