Ephedrine and pseudoephedrine to be removed from the National Drug Schedules by no later than June 28, 2024.

The National Association of Pharmacy Regulatory Authorities (NAPRA) policy on natural health products (NHPs) states that NHPs approved for sale under the Natural Health Products Regulations are not considered products for scheduling within the National Drug Schedules (NDS).

In accordance with this policy, and in the stepwise, risk-based approach initiated in 2019, NAPRA was to complete the elimination of all NHPs from the NDS with the removal of ephedrine and pseudoephedrine on January 2, 2024. However, this was postponed due to a request from Health Canada in mid-December 2023 to further delay the removal of single-ingredient ephedrine and pseudoephedrine from the NDS.

Following meetings with Health Canada in early 2024, and in good faith, NAPRA has agreed to delay the removal of single-ingredient ephedrine and pseudoephedrine from the NDS until Health Canada has implemented a measure to address these ingredients, or by no later than June 28, 2024, with the understanding that Health Canada would be able to address concerns with these ingredients within that timeframe. This will be the last extension granted.

In the interim, however, NAPRA will move forward with the removal of all NDS listings for combination products with ephedrine and pseudoephedrine from the NDS effective March 1, 2024.

In light of the above, as of no later than June 28, 2024, all products with a Natural Product Number (NPN) or Drug Identification Number-Homeopathic Medicine (DIN-HM) from Health Canada will be outside the scope of NAPRA’s NDS.

NAPRA believes the public interest will be best served through the development of a more comprehensive framework from the federal government that would better protect Canadians from the risks of the entire class of NHPs. As such, NAPRA will continue to engage in ongoing opportunities to further encourage the development of such a framework. More information on the background to NAPRA’s NHP policy can be found on the NAPRA website.