This proposed rule, if finalized, would establish, within Part 213, current good manufacturing practice (CGMP) regulations specific to medical gases. These proposed regulations include many of the same categories of requirements as the general drug product CGMP regulations but are tailored to reflect differences in how medical gases are manufactured, packaged, labeled, stored, and distributed.

This proposed rule, if finalized: would make limited changes to the labeling requirements of Part 201 including requiring that a “no smoking” statement, a “no vaping” statement, and graphic warning symbol be added to oxygen containers to reduce the risk of fire; would codify and clarify the process for obtaining a certification to market designated medical gases (DMGs); and would make changes to postmarketing safety reporting regulations for designated medical gases that address human and animal use and more specifically reflect the development, manufacturing, and distribution of designated medical gases.

Regulatory Impact Analysis

Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases Preliminary Regulatory Impact Analysis (PDF- 576KB)

Federal Register: 87 FR 31302, May 23, 2022

Docket: FDA-2021-N-1333