New Medical Gas Proposed Rule

FDA Issues Long-Awaited Notice of Proposed Rulemaking for Medical Gases

June 1, 2022

On May 23, 2022 the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services published a notice of proposed rulemaking to create separate regulations for medical gases.

The FDA describes the key provisions of this proposed rulemaking in the following way:

  • Proposed labeling requirements to clarify the statement of ingredients and quantity of contents, revise warning statements for certain designated medical gases, and establish more limited labeling requirements for bulk or transport containers.
  • Proposed current good manufacturing practices (CGMPs) requirements that recognize important differences in how medical gases are manufactured, labeled, and distributed, including the reuse of containers and labeling; mixing and commingling of gases; that gases are generally manufactured in a closed, pressurized system; and that many medical gases are generally not expected to expire or degrade.
  • Proposed regulations to codify the certification process for designated medical gases, including provisions regarding supplemental applications, annual reporting, and withdrawal or revocation of approval of an application.
  • Proposed safety reporting requirements that recognize certain events related to designated medical gases need not be reported to the Agency.

The publication of these proposed rules is a monumental step and one that could not have been accomplished without the hard work and dedication of CGA’s members. As you may know, the FDA committed to publish separate regulations for medical gases 44 years ago in the 1978 final rulemaking on CGMPs.  In 2017 and 2018, with a significant contribution of CGA member expertise and time, CGA submitted our own set of separate regulations to the FDA to inform their rulemaking process.  CGA has worked with Congress to keep consistent pressure on the FDA to advance these rules including a pointed question posed by a Senator to FDA Commissioner Califf in a hearing in April.

We must remember that this is a proposed rule and our continued efforts on this issue will be needed more than ever to ensure that FDA issues final regulations that are appropriate to the unique characteristics of medical gases.

“I want to congratulate CGA, its members, GAWDA and other CGA partners on achieving this long-awaited next step towards separate regulations for medical gases, and I look forward to working with you all to address any issues in the proposed rulemaking and ensure that final regulations are issued as soon as possible.” — Rich Gottwald, CGA President & CEO

How to Get Involved

CGA has formed an Expedited Work Process (EWP) Committee to respond to the notice of proposed rulemaking. The EWP Committee will meet by web conference on Thursday, 2 June 2022 from 10:00 AM – 12:00 PM (Eastern) and weekly though July 2022 to draft a joint CGA and Gases and Welding Distributors Association (GAWDA) response to the proposed rule. The work product from this EWP Committee will not be circulated to the CGA membership for review. It will be balloted directly to Standards Council for approval. The comment deadline is 22 August 2022.

Each CGA member company is permitted one vote on the EWP committee. Please contact Nicole Colantonio using the form below as soon as possible if you wish to join this EWP Committee.