Health Canada’s Interim Guide on IPA Hand Sanitizers

As the demand for hand sanitizer raises during the continuing coronavirus pandemic, Health Canada has seen an interest from many stakeholders in using isopropyl alcohol (IPA) as a basis of hand sanitizer. Health Canada obliged, releasing an Interim Guide on the Production of IPA for use in Alcohol-Based Hand Sanitizers. This guide outlines requirements on alternate sources of IPA while following U.S. Pharmacopeia (USP), European Pharmacopeia (Ph. Eur.), Food Chemical Codex (FCC), British Pharmacopoeia (BP), Pharmacopée française (Ph.f.), Pharmacopoeia Internationalis (Ph.I.), Japanese Pharmacopoeia (JP), and National Formulary (NF). If your IPA does not meet the requirements, it will not be considered acceptable. The guide directs that if you should choose to use technical grade IPA that you are required to notify Health Canada via e-mail, but you do not need to await approval. It should be noted that there are additional steps in the testing process if American Chemical Society grade or Raegent grade IPA is chosen for production. 

You still must have a product license, signified by an NPN, to manufacture, distribute, or import alcohol-based hand sanitizer. There are no additional labelling requirements from those previously outlined for hand sanitizers in the Guide on Health Canada’s Interim Expedited Licensing Approach for the Production and Distribution of Alcohol-Based Hand Sanitizers.  The guide includes a sample formulation as well. Finally, Health Canada declared in the guide that interim measures will cease once regular supplies stabilize. Any questions regarding the guide should be relayed to hc.nnhpd-dpsnso.sc@canada.ca .

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer productsregulated by Health Canada and the U.S. FDA.