Notice to Stakeholders: Expiration Dating for Medical Gases
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- General requirements
- Rationale
- Stratification of Medical Gas Mixtures
- Compliance and Enforcement
- Contact Information
Health Canada is issuing this notice 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 is no longer requiring 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.
For products that include a placeholder for the expiry date on their package label(s), Health Canada will accept the following:
- “EXP: None”
- “Expiration date: None”
- “Expiration: None”
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.
General requirements:
In Canada, if a gas or gas mixture is manufactured, sold or used as a pharmaceutical, it is considered a drug and is defined as a medical gas under Division 2 of Part C of the Regulations (C.02.002). Prior to being sold in Canada, all drug products are required to be labelled with an expiration date.
Division 1 of Part C of the Regulations define expiration date for a drug in dosage form as the year and month until the drug will maintain its labelled potency, purity, and physical characteristics. There are several provisions under Part C of Division 1 and Division 2 of the Regulations that relate to the expiration dating of drugs.
C.01.004(1) The inner and outer labels of a drug shall show…the expiration date of the drug
A manufacturer will typically determine their drug product's expiration date from the results obtained through stability testing of the drug product. The requirements to generate data and demonstrate stability of a drug product are found in Division 2 of Part C of the Regulations:
C.02.027(1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall establish the period during which each drug in the package in which it is sold will comply with the specifications for that drug.
(2) Every fabricator and importer of an active ingredient shall establish the period during which each drug in the package in which it is sold will comply with the specifications for that drug.
C.02.028(1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall monitor, by means of a continuing program, the stability of the drug in the package in which it is sold.
(2) Every fabricator and importer of an active ingredient shall monitor, by means of a continuing program, the stability of the drug in the package in which it is sold.
By combining Division 1 and Division 2 provisions, the Regulations are clear that for a drug product, an expiration date can be obtained through stability testing and this expiration date is required to be present on the product label.
Additionally, while the Regulations do not explicitly reflect that medical gases do not expire, the following provision of Division 2 of Part C of the Regulations exempts medical gases from the requirement to monitor the stability of the drug:
C.02.030 The provisions of sections…C.02.027 and C.02.028 do not apply to medical gases.
Rationale
The intent of the expiration dating requirement in the Regulations is to indicate the approved time prior to which the drug product is expected to remain within the approved stability specifications if stored under recommended conditions. Given the unique physical and chemical characteristics of medical gases, their difference in manufacturing and use, Health Canada recently considered whether the requirement for expiration dating on labels was reasonable for these types of drug products given that Division 2 exempts medical gases from the requirement to conduct stability testing. Health Canada examined the chemistry and manufacturing nature of oxygen, helium, nitrogen, carbon dioxide, medical air and nitrous oxide. These six gases were chosen as they have a long history of safe use in Canada. The Department has determined that these medical gases are indefinitely stable if kept in medically appropriate container closures and stored under proper conditions and therefore, expiration dating on product labels should not apply to these products.
Health Canada also considered the application of the Good Manufacturing Practices (GMP) regulations for medical gases and has acknowledged that they can be different from other drug products. For example, the manufacture of a medical gas may result in a gas being used as a raw material, or it may be sold as a bulk drug or as a finished packaged productFootnote 1. These differences make it necessary to alter GMP expectations when addressing such products. Health Canada has published specific guidance for medical gases (GUI-0031) to clarify the Department's expectations.
Stratification of Medical Gas Mixtures
Health Canada is aware of the physical phenomenon of stratification. Stratification of gas mixtures can occur if a medical gas product is stored in prolonged conditions that could allow the mixture to demix into its separate layers. One such condition could be medical gas cylinders that are sitting on delivery trucks that are being transported to their destination on a cold day. Once stratification occurs, the medical gas product could essentially be deemed expired at that time as it is no longer a homogenous mixture. Using the medical gas product in this physical state is a safety concern. However, if the medical gas cylinder is returned to proper storage conditions and/or rolled, the gas product is once again a homogenous mixture and can be safely used. In addition, if the medical gas cylinders are stored in a well ventilated area, stratification is not an issue.
Health Canada's interpretation of the regulatory requirement for expiration dating on labels was not designed to address phenomenon such as stratification. Health Canada will work with medical gas manufacturers to ensure that proper labelling on medical gas products exists to address this phenomenon to keep these products safe and ready for use.
Compliance and Enforcement
As part of its regulatory responsibilities, Health Canada promotes, monitors, and enforces compliance. With this change, Health Canada will no longer administer compliance for these medical gases on the expiration dating provision of the Regulations (C.01.004 (1)(c)(v)). Health Canada will also address this exemption through guidance for industry and appropriate inspector training and inspection practices.
For more information on compliance and enforcement, please refer to the Compliance and Enforcement Policy for Health Products (POL-0001) and to the Good Manufacturing guidance of medical gases (GUI-0031).
Contact Information
Bureau of Policy, Science and International Programs -
Therapeutic Products Directorate, Health Products and Food Branch
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