Interim Order: Ephedrine NHP Sales Restriction

Summary#

This Canada Gazette issue publishes several government notices. It (1) allows the controlled manufacture or import of a specific industrial chemical under conditions, (2) puts a proposed federal–Saskatchewan equivalency agreement on greenhouse gas rules out for comment, and (3) issues an Interim Order tightening how certain natural health products with ephedrine or pseudoephedrine can be sold.

What it does#

• Ministerial Condition No. 21762 under the Canadian Environmental Protection Act, 1999 permits the manufacture or import of the chemical 1,3-cyclohexanedimethanamine, N1,N3-bis(2-methylpropylidene)- (CAS No. 173904-11-5) but only under specific restrictions and record-keeping rules.
  • It bars importing or using the substance in consumer products covered by the Canada Consumer Product Safety Act, unless the substance is chemically reacted into a stable matrix and cured during manufacture.
  • It requires the original notifier to inform and get written confirmation from anyone they transfer the substance to, and to keep detailed records for at least five years.
  • These conditions came into force on May 23, 2024.
• The government made available, before it is signed, An Agreement on the Equivalency of Federal and Saskatchewan Regulations for the Control of Greenhouse Gas Emissions from Electricity Producers in Saskatchewan, 2025.
  • The proposed agreement was posted on June 8, 2024 and interested people have 60 days from that date to file comments or an objection with Environment and Climate Change Canada.
• The Interim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine (made on May 17, 2024) sets national, temporary conditions of sale for natural health products whose only medicinal ingredients are ephedrine and/or pseudoephedrine.
  • It generally prohibits retail sale of these products except when sold by a pharmacist (or someone under their supervision) and only when the product is not otherwise accessible to the public (for example, kept behind the counter).
  • It bars distributors from selling these products to non-pharmacy retailers for further retail sale.
  • The Order does not apply to products sold for clinical trials.
  • The measure is temporary: it lasts 14 days unless approved by the Governor in Council, in which case it can be in force for up to one year.
  • The move responds to NAPRA’s plan to remove single-ingredient ephedrine and pseudoephedrine products from its National Drug Schedules by June 28, 2024, which Health Canada says could otherwise create gaps in provincial point-of-sale rules and increase diversion risks (including for illegal methamphetamine production).

Who's affected#

• Chemical manufacturers and importers connected to the CAS No. 173904-11-5 substance, and businesses that might use it in products.
• Companies that buy, transfer, distribute, or sell that chemical (they must follow the notification, transfer and record rules).
• Retailers, distributors, pharmacies, and pharmacists involved with natural health products containing ephedrine or pseudoephedrine.
• Consumers who buy decongestant-style natural health products may need to obtain them from pharmacies rather than general stores.
• Provincial and territorial governments, and stakeholders in Saskatchewan’s electricity sector, who may take part in the equivalency agreement or comment on it.
• The public and interest groups who want to comment on the proposed greenhouse-gas equivalency agreement (within 60 days of June 8, 2024).

Why it matters#

• The chemical permission is not a blanket approval. It limits how the substance can be used and who can get it, aiming to reduce risks to people and the environment while allowing certain industrial uses.
• The interim federal sales rules for ephedrine and pseudoephedrine aim to reduce misuse and diversion of these products (notably their use as precursors in illegal methamphetamine production). That will make buying some over-the-counter natural health products less convenient for consumers but seeks to improve public safety.
• The proposed equivalency agreement could affect how greenhouse gas controls for Saskatchewan electricity producers are applied and enforced; the public has a short window to review and comment.