On May 17, 2024, Health Canada published the Interim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine. This order introduces specific condition-of-sale regulations for natural health products (NHPs) that contain ephedrine or pseudoephedrine as their sole medicinal ingredients. The order aims to mitigate the significant health and safety risks associated with the misuse and diversion of these substances, particularly their potential use in the illegal production of methamphetamine.
Before the issuance of this Interim Order, ephedrine and pseudoephedrine were regulated under Schedule II of the National Drug Schedules (NDS) by the National Association of Pharmacy Regulatory Authorities (NAPRA). This classification required that these products be sold only with a pharmacist’s intervention and from areas of a pharmacy that are inaccessible to the public, such as behind the counter. Since 2019, NAPRA has been systematically removing NHPs from its NDS, with single-ingredient ephedrine and pseudoephedrine products being the last remaining NHPs scheduled for removal by June 28, 2024. These changes would have left a regulatory gap, as most provincial and territorial laws reference NAPRA’s NDS, thus no longer applying to these products.
Under the new Interim Order, NHPs containing ephedrine, pseudoephedrine, or both as their only medicinal ingredients are subject to strict condition-of-sale measures:
This Interim Order effectively mirrors the previous requirements under Schedule II of the NDS but adds federal enforcement to prevent non-pharmacy retailers from selling these products.
The key takeaway from this Interim Order is the restriction on sales of ephedrine and pseudoephedrine to non-pharmacy retailers. While Schedule II of the NDS required these products to be sold by pharmacists, it did not explicitly prevent non-pharmacy retailers from selling them. The Interim Order now ensures that only pharmacies can retail these products, thereby reducing the risk of misuse and diversion.
To mitigate any potential revenue losses, distributors and retailers dealing with NHPs containing ephedrine or pseudoephedrine should redirect their sales channels to pharmacies. Ensuring compliance with the Interim Order will not only align with federal regulations but also help maintain the integrity and safety of these products in the market. Retailers that previously sold these NHPs should establish partnerships with pharmacies to continue offering these products within the new legal framework.
If you have questions about this Interim Order or any other regulatory affairs matters, please contact us. We are here to help you navigate these changes and ensure your business remains compliant with the latest regulations.