Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry

Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry

FDA issued an immediately in effect guidance that outlines a temporary policy to help expand the availability of portable cryogenic oxygen and nitrogen containers. The demand for these critical medical gases is expected to rise during the COVID-19 pandemic and may result in a shortfall of portable cryogenic medical gas containers that meet regulatory requirements. FDA does not intend to take enforcement action against firms that fill and distribute oxygen and nitrogen in portable cryogenic medical gas containers that are not in compliance with 21 CFR 211.94(e)(1) provided alternative, specific safeguards are in place to prevent gas mix-ups. In addition to only distributing containers that are not compliant with § 211.94(e)(1) when § 211.94(e)(1)-compliant portable cryogenic medical gas containers are unavailable, these alternative safeguards include the use of a container fitted with a tamper-evident connection that is suitable for its intended use,  associated labeling to prevent tampering, recordkeeping, training, and removal of containers not compliant with § 211.94(e)(1) as soon as practicable during or at the end of the public health emergency. This guidance will be in effect until the end of the public health emergency.

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