FDA Revises cGMP and Labeling Regulations of Medical Gases

  • By: Staff Editor
  • Date: November 21, 2016
  • Source:
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The US FDA recently amended its cGMP and labeling regulations for medical gases. The chief impetus for modifying the regulation was the number of injuries and deaths where medical gas containers carrying gases other than oxygen were falsely connected to a healthcare’s facility oxygen supply system.

FDA in the Federal Register said, “The final rule is 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.”

Summary of the Requirements of Final Rule:

  • Portable cryogenic medical gas containers that are not manufactured with permanent gas use outlet connections should have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer.
  • Portable cryogenic medical gas containers and high-pressure medical gas cylinders must meet certain labeling, naming, and color requirements. Specifically it requires:
    • A 360º wraparound label clearly identifying the container's contents be affixed near the top of portable cryogenic medical gas containers.
    • High-pressure medical gas cylinders be painted an FDA-designated, gas-specific standard color.
  • The final rule further modifies the medical gas conditional labeling exemption regulation to add oxygen and nitrogen to the list of medical gases subject to the exemption, and to remove cyclopropane and ethylene from the list.
  • It also revises this regulation by adding new warning statement content to be included in oxygen labeling and by expanding the scope of the regulation to include medically appropriate mixtures of medical gases.

Compliance Dates:

The Final Rule is effective January, 17, 2017. The affected businesses are encouraged to comply as soon as possible after the effective date. The compliance date to fully implement this rule is May 17, 2017.

Related Training:

Effective Annual U.S. FDA CGMP Training

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