Health Canada has issued an Order Establishing Supplementary Rules Respecting the Sale of Natural Health Products Containing Ephedrine or Pseudoephedrine (“the Order”), which comes into force on May 18, 2025.
The Ministerial Order supersedes rules outlined in the Interim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine, which was introduced in 2024 and is set to expire on May 17, 2025. The rules in the Order ensure that only pharmacists (or individuals working under the supervision of pharmacists) may sell natural heath products (NHPs) containing non-combination ephedrine and/or pseudoephedrine products (i.e., single-entity products), and only where such products are otherwise not accessible to the public (e.g., behind the counter at a pharmacy, similar to the storage and some of the sale requirements of Schedule 2 products). However, these non-combination products do not require additional Schedule 2 product sale requirements, such as an assessment of appropriateness or a documentation of sale on the patient record.
Combination ephedrine and/or pseudoephedrine products can be sold at the pharmacy in the self-selection area, where a pharmacist is available, at the request of a purchaser or consumer, to discuss the product prior to purchase, similar to the storage and sale requirements of a Schedule 3 product.
The Ministerial Order limits the sale of these NHPs to pharmacies. This is achieved by prohibiting the sale of these NHPs (i.e., by wholesalers or other distributors) to retail stores that are not pharmacies.
Health Canada noted that the Order is necessary because NHPs containing ephedrine and/or pseudoephedrine are at risk of misuse such as for the purposes of performance enhancement and weight loss, and are at risk of diversion for the illegal production of methamphetamine. The Ministerial Order and the preceding Interim Order were 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.
For Alberta pharmacy teams, this means that these non-combination products are not Schedule 2 products. However, these products must remain for sale behind the counter and out of public access.
