CGMP Regulations - 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.
  • Questions and Answer on on the Proposed Rule for Medical Gas Containers
• Draft Guidance for Industry on the Current Good Manufacturing Practice for Medical Gases (PDF - 437 KB)
• Compressed Medical Gases Guideline, February 1989.  - 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 (CGMP Regulations 21 CFR Parts 210 and 211).
• Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory (PDF - 19 KB) 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.   

Other Medical Gas Information:

• Search for Medical Gas Warning Letters
• Medical Gas Seizure Actions (PDF - 10 KB) Listing of seizure actions taken by the Agency for Fiscal Year 1993 to present
• Batch Production Record (PDF - 7 KB) This is an example of a batch production record for filling high pressure cylinders.