Sale Rules for Ephedrine NHPs

Summary#

The Order Establishing Supplementary Rules Respecting the Sale of Natural Health Products Containing Ephedrine or Pseudoephedrine limits how and where certain natural health products with ephedrine or pseudoephedrine can be sold. It keeps these products mostly inside pharmacies and restricts wholesalers so they can only sell to pharmacists. The order takes effect on May 18, 2025.

What it does#

• Applies to two types of natural health products:
  • non-combination products — products whose only medicinal ingredient(s) are ephedrine and/or pseudoephedrine.
  • combination products — products that include ephedrine and/or pseudoephedrine plus one or more other natural health product ingredients listed in the Natural Health Products Regulations.
• Prohibits retail sale of those products except in pharmacy settings:
  • Non-combination products may only be sold at retail by a pharmacist or someone working under a pharmacist’s supervision, and they must not be available for open self-selection by the public.
  • Combination products may only be sold at retail through a pharmacy. They may be available for self-selection only if a pharmacist is available (including remotely) to discuss the product before purchase; otherwise pharmacies can keep them out of public self-selection areas.
• Prohibits wholesalers and distributors from selling these products to non-pharmacy retailers. Sales for further retail sale are limited to pharmacies.
• Applies to both physical and online sales, with the same pharmacy/ pharmacist requirements for remote or online transactions.
• Allows the Minister of Health to suspend, reinstate, or cancel product or site licences if there are reasonable grounds to believe the order was contravened.

Who's affected#

• Pharmacies and pharmacists — they will be the primary legal retail sellers of these products.
• Natural health product manufacturers, licence holders, distributors and wholesalers — they will generally only be allowed to sell to pharmacies.
• Non-pharmacy retailers (grocery stores, health stores, etc.) — these businesses can no longer sell these products at retail.
• Consumers who use these products for legitimate purposes (for example as decongestants) — products may be harder to find if local pharmacies choose not to stock them.
• Small businesses that previously sold these products outside pharmacies — the government estimates annual net losses for affected distributors of about $481,012 in total (about $160,337 per business on average).
• Government enforcement resources — Health Canada estimates about $30,000 per year to verify compliance.
• Other stakeholders: the order was made with input from provinces, territories, pharmacy regulators and industry.

Why it matters#

• The rule aims to reduce misuse of ephedrine and pseudoephedrine products (for weight loss, performance enhancement) and to limit their diversion into illegal methamphetamine production. Limiting sales to pharmacies lets trained professionals advise consumers and makes bulk diversion harder.
• The order continues the same basic limits that were in an earlier interim rule so there is no regulatory gap after May 17, 2025 (the interim rule’s last day).
• It may make some products less available to people who rely on them for legitimate uses, since pharmacies are not required to stock every product. Health Canada notes that some pharmacies have shown limited interest in carrying these items.
• The government estimates the combined annual direct financial impact on industry and government at about $511,012. An estimated indirect annual impact on contract manufacturers is about $371,767.