Ephedrine sales restricted; chemical import conditions

Summary#

This Canada Gazette issue contains several government notices. Key items are a ministerial condition under the Canadian Environmental Protection Act, 1999 allowing controlled manufacture/import of a specific industrial chemical, a notice that an equivalency agreement for Saskatchewan greenhouse-gas rules is available for comment, and an Interim Order from Health Canada that restricts retail sales of natural health products containing ephedrine or pseudoephedrine.

What it does#

• Ministerial Condition No. 21762 (under the Canadian Environmental Protection Act, 1999):

  • Allows the notifier who provided information on the substance 1,3-cyclohexanedimethanamine, N1,N3-bis(2-methylpropylidene) (CAS 173904-11-5) to manufacture or import it, but only under specific conditions.
  • Key limits include: the substance must not be imported or manufactured in consumer products unless it is chemically reacted into a stable matrix and cured; transfers are allowed only to people who agree to the conditions; and the notifier must keep detailed records and make them available at their Canadian place of business.
  • These conditions came into force on May 23, 2024.

• Notice of proposed equivalency agreement:

  • The proposed document titled “An Agreement on the Equivalency of Federal and Saskatchewan Regulations for the Control of Greenhouse Gas Emissions from Electricity Producers in Saskatchewan, 2025” is available on the department’s Environmental Registry as of June 8, 2024.
  • The notice invites comments or notices of objection within 60 days of the Canada Gazette publication.

• Interim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine (made May 17, 2024) under the Food and Drugs Act:

  • Prohibits retail sale of natural health products whose only medicinal ingredients are ephedrine and/or pseudoephedrine — except when sold by a pharmacist (or someone working under their supervision) and only when the product is not otherwise accessible to the public (for example, kept behind the counter).
  • Prohibits distributors from selling these products to non-pharmacist retailers for further retail sale.
  • Does not apply to sales for clinical trials regulated under the Natural Health Products Regulations.
  • The order is temporary: it lasts 14 days unless approved by the Governor in Council, in which case it could remain in force for up to one year while longer-term measures are developed. The change responds to NAPRA’s planned removal of single-ingredient ephedrine and pseudoephedrine products from its National Drug Schedules by June 28, 2024.

• Appointments and public-service notices:

  • The Privy Council Office lists a range of Governor in Council appointment openings. Several application deadlines (for example, some closing on June 20, 2024) are noted on the appointments website.

Who's affected#

• The notifier named in Ministerial Condition No. 21762 and any companies that manufacture, import, distribute, or use the chemical 1,3-cyclohexanedimethanamine (CAS 173904-11-5).
• Manufacturers and sellers of consumer products that might contain that chemical — they must ensure the substance is reacted into a stable, cured matrix if used.
• Pharmacies, pharmacists, pharmacy staff, distributors, and retailers handling natural health products with ephedrine or pseudoephedrine.
• Licence holders and distributors of natural health products who may need to change wholesale or retail sales channels.
• Anyone or any group wanting to comment on the proposed Saskatchewan-federal equivalency agreement (comments invited within 60 days).
• Canadians interested in federal appointments listed by the Privy Council Office.

Why it matters#

• The ministerial conditions put legal limits and record-keeping rules around a specific industrial chemical. That can affect how companies import, make, sell, or use products that include it.
• The Interim Order from Health Canada tightens where and how certain ephedrine/pseudoephedrine products can be sold. For consumers, that likely means these products will generally only be available through pharmacies and not from general retail stores. For distributors, it limits which retailers they can supply.
• The Interim Order is explicitly aimed at reducing misuse and diversion of these ingredients (including their use as precursors in illegal drug production) while federal and provincial partners work on longer-term solutions.
• The Saskatchewan equivalency agreement notice gives affected industries and the public a chance to review and comment before it’s finalized.