After many years of discussion between the Compressed Gas Association (CGA) and Health Canada, it was recently announced that common medical gases and medical gas mixtures in Canada will no longer require labeling with an expiration date.
Specifically, Health Canada will no longer require medical gas manufacturers of the following gases and their medically appropriate mixtures to have expiration dating on their product labels: oxygen, helium, nitrogen, carbon dioxide, medical air, and nitrous oxide.
Health Canada issued its Notice to Stakeholders: Expiration Dating for Medical Gases on March 23, 2021, to communicate the Department’s interim approach on the exemption of certain medical gases and their medically appropriate mixtures from the requirement to have an expiration date on a product label as per Division 1 of Part C of the Food and Drug Regulations (the Regulations).
Health Canada will maintain this approach on expiration dating for medical gases until such time that appropriate amendments can be made to the Regulations. Health Canada will continue to examine other medical gas products on a case by case basis for consideration of exemption from expiration dating on product labels.
CGA has worked closely with Health Canada on this issue, providing rationale for the exemption detailed in the March 23 notice. Common medical gases (oxygen, nitrogen, medical air, carbon dioxide, nitrous oxide, and helium) and their mixtures are indefinitely stable, given their unique physical and chemical characteristics. Health Canada regulations had already exempted medical gases from stability testing. CGA thanks Health Canada for this important policy decision.
CGA looks forward to working with Health Canada in the coming months to review stratification of medical gas mixtures under certain conditions and what appropriate information should be included on medical gas mixture labels.
