Tighter Controls on Chemical Precursors

Summary#

These final amendments to the Precursor Control Regulations were published in the Canada Gazette, Part II on December 17, 2025. They add new reporting and security duties for businesses that handle chemical precursors, tighten retail rules for products containing ephedrine or pseudoephedrine, and extend import controls to parts of pill presses and capsule machines.

What it does#

• Requires licensed and registered dealers who suspect a transaction may be linked to diversion of a precursor to file a written report to Health Canada within 72 hours.
• Requires licensed dealers who handle higher‑risk precursors (Class A) to take “reasonable measures” so employees do not help divert precursors to illegal uses. Records of those measures must be kept for two years.
• Adds sale restrictions for products containing ephedrine or pseudoephedrine so they can only be sold by or through pharmacies, hospitals, or health practitioners. Single‑ingredient ephedrine natural health products must be sold behind the counter; many combination products can remain on open display but a pharmacist must be available on request.
• Gives Health Canada more flexibility to add, change or remove conditions on licences and registrations, or to partially suspend specific activities, in order to respond faster to risks. Some changes can be made immediately in urgent cases.
• Amends Schedule IX to the Controlled Drugs and Substances Act to require import registration for certain component parts (punches, moulds, dies) used with pill presses and encapsulators, so those parts cannot be imported without prior registration.
• Repeals the Ministerial Order that separately regulated some natural health products containing ephedrine/pseudoephedrine; its retail rules are incorporated into the amended regulations.

Note: Most amendments come into force on the day of publication (December 17, 2025). The mandatory reporting and the requirement to take reasonable measures come into force on the 180th day after publication to give businesses time to prepare.

Who's affected#

• Licensed and registered dealers who handle precursors (manufacturers, distributors, pharmacies, wholesalers).
• Importers of pill‑press or capsule‑making equipment and certain component parts (punches, moulds, dies).
• Health Canada (will receive and process reports, run registration systems, and do compliance work).
• Pharmacists, hospitals and regulated practitioners — they will be the main retail channels allowed to sell many ephedrine/pseudoephedrine products.
• Consumers who buy over‑the‑counter products containing ephedrine or pseudoephedrine may see changes in where and how some products are sold.
• Law enforcement and border agencies may get more information from Health Canada to help detect diversion.

If something in the rules is unclear for a particular business or product, the amendments say Health Canada will provide guidance; the Gazette notice includes more technical details.

Why it matters#

• The government says these steps aim to reduce the diversion of chemical precursors into illegal drug production (for example, methamphetamine and fentanyl). Mandatory reports and faster licence tools are designed to help spot suspicious trades sooner.
• For businesses, the changes mean new paperwork and some new costs — the regulatory analysis estimates overall present‑value costs of about $1.01 million, or an annualized cost of about $143,274, over 10 years. Health Canada expects roughly 120 additional suspicious‑transaction reports per year compared with past voluntary reporting.
• For consumers, some products containing ephedrine or pseudoephedrine will be restricted to pharmacy‑type points of sale or require pharmacist access, which could change how and where people buy certain cold, allergy, or decongestant products.
• For border control, adding parts of pill presses to Schedule IX closes a loophole where equipment could be imported in pieces to avoid registration.

If you handle precursors, import related equipment, or run a pharmacy, you may need to update your procedures. For questions the regulations point to Health Canada as the contact for implementation and guidance.