Tighter Controls on Drug Precursors and Pill-press Parts

Summary#

This is a proposed package of changes, published in the Canada Gazette on June 28, 2025, that would tighten controls over chemical precursors and some drug-manufacturing equipment. It would require more reporting and internal checks for businesses that handle these chemicals, limit some retail sales of products containing ephedrine or pseudoephedrine, and expand import controls to parts used in pill presses. Comments are open for 45 days after publication.

What it does#

• Gives Health Canada new powers to change licence or registration conditions at any time and to partially suspend specific activities on a licence.
• Requires licensed and registered dealers who deal with precursors to file a written report to Health Canada within 72 hours when they have reasonable grounds to suspect a transaction is linked to diversion to illegal drug production. Reports must be kept for 2 years.
• Protects reporters from civil suits if the report was made in good faith and provides limited protection against self-incrimination for dealers and their agents when reporting loss, theft or suspicious transactions.
• Requires licensed and registered dealers to take “reasonable steps” to reduce the risk that employees will help divert precursors. Reasonable steps must consider whether an employee has been convicted of certain offences in the previous 10 years.
• Moves the retail sale rules for ephedrine/pseudoephedrine products into the Precursor Control Regulations (PCR) and extends sale restrictions to non-prescription drugs (not just natural health products). Key retail rules:
  • Single-ingredient ephedrine/pseudoephedrine products must be sold behind the counter by a pharmacist.
  • Combination products can be sold where the public can self-select, but a pharmacist must be available on request (including for online sales by phone/video/text).
  • Sales by non-pharmacy retailers would be restricted.
• Expands import registration under Schedule IX to the Controlled Drugs and Substances Act (CDSA) to cover certain component parts—specifically punches, moulds and dies—that are suitable for use in pill presses or encapsulators. Importers must register these parts before arrival and show proof at the border.
• Proposes repeal of the Order Establishing Supplementary Rules Respecting the Sale of Natural Health Products Containing Ephedrine or Pseudoephedrine to avoid duplication (those sale rules would be folded into the PCR).
• Health Canada estimates the total cost of the proposed changes at about $2.04 million in present value over 10 years (annualized about $290,093). There would also be an additional administrative burden estimated at $83,722 (present value) over 10 years.

Who's affected#

• Licensed and registered dealers who produce, import, distribute or sell chemical precursors.
• Importers of equipment and component parts used in pill presses and encapsulators.
• Pharmacies, pharmacists and other health practitioners and hospitals that sell or provide ephedrine/pseudoephedrine products at retail.
• Manufacturers, distributors and exporters of products that legitimately contain precursors (pharmaceutical, fragrance, chemical industries).
• Border and law enforcement agencies such as the Canada Border Services Agency (CBSA) and the Royal Canadian Mounted Police (RCMP) (will use the new information and registration tools).
• Small businesses appear to be a large share of affected firms; Health Canada estimates many impacted businesses are small and that compliance costs would not be negligible.

Why it matters#

• The changes aim to make it harder for organized crime to divert legitimate precursor chemicals or import parts that can be assembled into equipment for clandestine production of fentanyl and other synthetic drugs. That is intended to help reduce harms tied to the overdose crisis.
• For businesses that handle precursors, the real effects are more paperwork, faster reporting of suspicious transactions, and new personnel-security steps. That could increase costs and operational checks, especially for small firms.
• Pharmacies and online sellers will face clearer rules about how ephedrine- and pseudoephedrine-containing products can be sold, which may affect where and how customers can buy them.
• Importers of replacement parts for legitimate machines may need to plan for registration ahead of shipments to avoid border delays.
• These are proposed regulations, not final. Interested parties had the opportunity to comment for 45 days after the Canada Gazette notice of June 28, 2025.