The Regulations Amending the Precursor Control Regulations (Increased Regulatory Oversight), SOR/2025-260, represent a significant update to Canada’s framework for controlling chemical precursors and equipment used in the production of illegal drugs, particularly fentanyl, fentanyl analogues, and methamphetamine. Enacted under the Controlled Drugs and Substances Act (CDSA), these amendments are in response to the growing public health and safety crisis posed by synthetic opioids, which have caused tens of thousands of deaths, hospitalizations, and emergency department visits in recent years.

The amendments address several key areas. First, they introduce mandatory reporting of suspicious transactions involving precursors. Licensed and registered dealers are now required to notify Health Canada within 72 hours of identifying transactions they reasonably suspect may involve diversion to illegal drug production. Previously, reporting was voluntary, although records had to be maintained. These mandatory reports must include detailed explanations for the suspicion and be retained for two years, even for dealers no longer licensed. Protective measures are included to shield reporters from civil liability and partial self-incrimination.

Second, the regulations require licensed dealers handling Class A precursors to implement reasonable measures to prevent employees from diverting chemicals to illegal use. This requirement is focused on Class A precursors due to their high potential for misuse and does not extend to Class B precursors. Licensed dealers must submit a statement confirming these measures to Health Canada, retain relevant records for two years, and can tailor measures according to business size, type, and risk. This provision also comes into force after a six-month transition.

Third, the amendments establish condition-of-sale restrictions for natural health products (NHPs) and non-prescription drugs (NPDs) containing ephedrine or pseudoephedrine. These Class A precursors, previously regulated under the NAPRA National Drug Schedules, now fall under the PCR to prevent duplication and ensure consistent federal oversight. Non-combination NHPs can only be sold behind the pharmacy counter, while combination products may be sold in areas accessible to the public if a pharmacist is available for consultation. Sale is restricted to licensed dealers, pharmacists, hospitals, and health care practitioners, maintaining controlled access while permitting legitimate use. Retail packaging limits prevent bulk diversion.

Fourth, the amendments aim to improve Health Canada’s regulatory flexibility. The Minister can now add, modify, or remove conditions on licences or registrations at any time, partially suspend licences or registrations, and impose conditions on transit and transhipment permits at issuance. These measures allow rapid responses to emerging threats and targeted interventions without unnecessarily disrupting business operations.

Canada (260/2025) February 4, 2026
Disclaimer: Insights are for informational purposes only and does not reflect RRI’s official position or constitute legal opinion.