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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- Draft Guidance for Industry on the Current Good Manufacturing Practice for Medical Gases [Word]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).
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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
(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
(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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