Part IOrderVolume 158, Number 23Published: June 8, 2024

Pharmacy-only sales for ephedrine NHPs

Canada Gazette, Part I, Volume 158, Number 23: ORDERS IN COUNCIL

DEPARTMENT OF HEALTH

Key facts

Published
June 8, 2024
Comment deadline
Unclear
Effective date
May 31, 2024

Summary#

This Order in Council approves the Interim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine, which the Department of Health made to keep tighter retail controls on certain natural health products. The approval (P.C. 2024-619, dated May 31, 2024) extends the Interim Order beyond its initial 14‑day expiry so it can stay in effect temporarily while longer-term rules are developed.

What it does#

  • Keeps special sale rules for natural health products (NHPs) that contain ephedrine, pseudoephedrine, or both as their only medicinal ingredient.
  • Requires that, at retail, these products be sold only by pharmacists or people working under a pharmacist’s supervision, and only where the products are not directly accessible to the public (for example, behind the pharmacy counter).
  • Stops distributors (wholesalers) from selling these NHPs to retail stores that are not pharmacies. Distributors must sell them only to pharmacies.
  • Applies to both in-person and online sales, but allows online or remote sales only when a pharmacist (or supervised staff) intervenes in the sale.
  • Excludes sales for clinical trials and excludes distribution by health-care practitioners acting within their normal professional role.
  • The approval keeps the Interim Order in force until the earliest of: it is repealed, formal regulations with the same effect come into force, or one year after the Interim Order was made.

Who's affected#

  • Pharmacists and pharmacy staff — they remain the only retail sellers of these specific NHPs.
  • Distributors and wholesalers who handle NHPs containing ephedrine or pseudoephedrine — they can no longer sell to non‑pharmacy retailers.
  • Retail stores that are not pharmacies — they can no longer sell these products to the public.
  • Consumers who buy NHPs with ephedrine or pseudoephedrine — access will be limited to pharmacies.
  • National Association of Pharmacy Regulatory Authorities (NAPRA) — its planned removal of single‑ingredient ephedrine and pseudoephedrine from its drug schedules (by June 28, 2024) prompted this federal action.
  • Producers and licence holders of these NHPs — may see changes in where and how their products are distributed and sold.

Why it matters#

  • The measure is meant to keep current point-of-sale controls in place across Canada after NAPRA plans to remove single‑ingredient ephedrine and pseudoephedrine from its national schedules. Without federal action, some provincial rules tied to NAPRA’s schedules could stop applying and make these products easier to buy.
  • Health Canada says easier access to single‑ingredient ephedrine and pseudoephedrine increases the risk they will be misused or diverted as precursors for illegal methamphetamine production. This order aims to reduce that risk by limiting who can buy and sell the products.
  • For shoppers, the practical effect is that these products will remain pharmacy‑only for now. For distributors and retailers, it may mean redirecting sales channels to pharmacies while longer-term rules are decided.

Key topics

Food and Drugs ActInterim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or PseudoephedrineNatural Health Products RegulationsNational Association of Pharmacy Regulatory AuthoritiesNAPRANational Drug SchedulesNDSephedrinepseudoephedrinemethamphetamineHealth Canadapharmacistsdistributorsnatural health products

Source: Canada Gazette

Official source