FDAnews Drug Daily Bulletin

FDA Relaxes 14-Year-Old Recommendations for Medical Gas GMP Compliance

July 5, 2017

The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing some recommendations on expiration dating and warehousing procedures.

The agency said it no longer intends to object if manufacturers do not comply with CFR requirements for expiration dating of designated medical gases with unique stability characteristics.

The previous version, issued in 2003, required that each container bear an expiration date, based on related storage conditions, and recommended that high-pressure cylinders stored for long periods be monitored for correct pressure and periodically verified.

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