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Interim Order for sale of ephedrine and pseudoephedrine

July 23, 2024
Pharmacy professional helping patient at the pharmacy counter.
Natural health products containing either product as their only medicinal ingredients must only be available behind the counter at pharmacies.

Health Canada has issued an Interim Order concerning the sale of certain natural health products (NHPs) containing ephedrine or pseudoephedrine. Citing concerns about potential risks for misuse and diversion, NHPs containing ephedrine, pseudoephedrine, or ephedrine and pseudoephedrine as their only medicinal ingredients, the Interim Order includes rules to ensure that only pharmacists (or individuals working under the supervision of pharmacists, such as pharmacy technicians) may sell such products, and only where such products are otherwise not accessible to the public (e.g., behind the counter at a pharmacy). The Interim Order also prohibits persons (i.e., distributors) from selling these NHPs to retail stores other than pharmacies, by limiting such sales to pharmacies. The Interim Order will remain in effect for up to one year (May 17, 2025).

The Order was deemed necessary as ephedrine and pseudoephedrine became unscheduled by the National Association of Pharmacy Regulatory Authorities (NAPRA) as of June 28, 2024. NAPRA has been removing NHPs from its National Drug Schedules (NDS) since 2019 through a stepwise, risk-based approach; these two products represented the last two remaining NHPs on its NDS.

According to Health Canada’s explanatory note, the Interim Order is intended to address the risks noted above on an urgent and temporary basis until Health Canada can propose longer-term solutions in further consultation with the provinces and territories.

For Alberta pharmacy teams, this means that, even though these products will no longer be considered Schedule 2, they must remain for sale behind the counter and out of public access.