Interim guide on isopropyl alcohol for use in alcohol-based hand sanitizers and disinfectants: Manufacturing responsibilities
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Manufacturer responsibilities of the finished dosage
You must apply good manufacturing practices (GMP) for all finished dosage form NHPs, including hand sanitizers. Please refer to part 3 of the Natural Health Products Regulations. For instance, the quality assurance person must:
- confirm that the isopropyl alcohol (IPA) lot purchased or acquired includes a lab Certificate of Analysis (CoA) with impurities, medicinal ingredient/active ingredient identity, quantity, microbiological and chemical test results
- compare the test results against the applicable quality standards and the approved product specifications
- trace each lot of IPA to the products produced
- recall the product if there is a quality issue
- quarantine any suspect lots of IPA or finished hand sanitizers
- take steps to ensure that quarantined products are not released for use or sale
Other GMP requirements include requiring that:
- activities be carried out in sanitary conditions and in accordance with a sanitation program and standard operating procedures
- equipment be designed, built, maintained and operated according to its intended use and in a way that prevents contamination
- staff have the necessary education, training or experience to do their job
- environmental monitoring is done to ensure alcohol-based hand sanitizers are manufactured, packaged, labelled, imported and stored properly
Disinfectants do not have to meet the GMP requirements set out in the Food and Drug Regulations. However, they must be produced under sanitary conditions and not adulterated. To support compliance with this regulatory requirement, we developed the voluntary standard for fabricating, controlling and distributing antimicrobial agents for environmental surfaces and certain medical devices (GUI-0049). We encourage you to review and apply this standard where possible.
Labelling requirements
Alcohol-based hand sanitizers must meet the labelling requirements outlined in our licensing approach to produce and distribute alcohol-based hand sanitizers. For disinfectants, you must meet the labelling requirements outlined in the 2020 disinfectant drugs guidance document.
There are no specific, additional labelling requirements for hand sanitizers and disinfectants containing IPA. Any IPA (including technical-grade) acceptable for use in hand sanitizers and disinfectants must meet or exceed the quality standards set out in this guide.
Excise tax implications
Alcohol importers may have additional registration requirements under legislative frameworks, such as the Excise Act, which the Canada Revenue Agency administers.
For questions or further information, please see the excise duties, excise taxes, fuel charge and air travellers security charge webpage. This page includes contact information for your regional excise duty office, which is your best source for information on excise taxes.