Pharmacy-only Sales for Ephedrine and Pseudoephedrine NHPs
Canada Gazette, Part I, Volume 158, Number 23: ORDERS IN COUNCIL
The Governor in Council approved an Interim Order (approved May 31, 2024) that keeps temporary sale restrictions on natural health products (NHPs) whose only medicinal ingredient is ephedrine, pseudoephedrine, or both. The measures require pharmacist intervention and behind-the-counter storage, ban distributors from selling these NHPs to non-pharmacy retailers, and apply to both in-person and online sales while longer-term rules are developed.
- Published
- June 8, 2024
- Department
- Unavailable
- Section
- DEPARTMENT OF HEALTH
- Comment deadline
- Unavailable
- Effective date
- May 31, 2024
- Publication part
- Part I
Summary
Summary#
The federal government has approved the Interim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine. The approval, made by Order in Council on May 31, 2024, keeps temporary rules that limit how single-ingredient ephedrine and pseudoephedrine natural health products can be sold while longer-term options are worked out.
What it does#
- Keeps in place a temporary rule (the Interim Order, originally made on May 17, 2024) that restricts retail sales of natural health products (NHPs) whose only medicinal ingredient is ephedrine, pseudoephedrine, or both.
- Requires those products to be sold only by a pharmacist (or someone working under a pharmacist’s supervision, such as a pharmacy technician) and only where the products are not accessible to the public (for example, behind the counter).
- Stops distributors from selling these products to retail stores that are not pharmacies. In other words, wholesalers should only sell them to pharmacies.
- Applies to both in-person and online sales, but allows remote or online sales only when a pharmacist (or supervised staff) intervenes and the product remains otherwise inaccessible to the public.
- Excludes sales made as part of a regulated clinical trial and excludes health-care practitioners giving products to patients as part of care under provincial/territorial rules.
- The approval extends the Interim Order until the earliest of: it is repealed, regulations with the same effect come into force, or one year after the Interim Order was made.
Who's affected#
- Retail pharmacists and pharmacy staff who will continue to be the only retail point of sale for these products.
- Distributors and wholesalers that sell NHPs containing ephedrine or pseudoephedrine; some will no longer be able to sell to non-pharmacy retailers.
- Non-pharmacy retailers (for example, convenience stores or supermarkets) that might previously have sold these products — they will no longer be able to sell them to the public.
- Consumers who use over-the-counter NHPs with ephedrine or pseudoephedrine; they may need to obtain them from a pharmacy rather than other stores.
- The natural health product industry and licence holders, who may need to adjust sales channels.
- Provincial and territorial regulators and pharmacy authorities, who were consulted and generally support the measure. It was prompted in part because NAPRA planned to remove these items from its National Drug Schedules (NDS) by June 28, 2024, which would have left a regulatory gap.
Why it matters#
- These products can be misused and can be diverted as precursors for illegal methamphetamine production. The rules aim to keep tighter control over who can buy and sell them to reduce that risk.
- The measure preserves the existing behind-the-counter, pharmacist-supervised approach across Canada while the federal government and provinces work on longer-term solutions.
- For shoppers, it means less convenience in where you can buy these specific NHPs, but it aims to protect public health and safety by reducing illegal diversion.
Key topics
Source: Canada Gazette