Controlled Substances Rules Updated for Drugs and Precursors

Summary#

These are final amendments, published December 17, 2025, that change several health and drug rules to align how controlled drugs, narcotics, precursors and some cannabis-containing drugs are defined, labelled, licensed and tracked. The amendments update parts of the Food and Drug Regulations, the Medical Devices Regulations and the rules that control precursors and other controlled substances under the Controlled Drugs and Substances Act. They come into force when the Controlled Substances Regulations come into force (the date is not given in this notice).

What it does#

• Changes and harmonizes definitions used across rules, including who counts as a nurse practitioner and which drugs are treated as prescription, controlled, narcotic or targeted substances.

• Updates label requirements so certain symbols (for example “Pr” for prescription drugs and symbols for controlled drugs, narcotics and targeted substances) must appear on product labels.

• Adjusts packaging rules, including limits on dosage units for controlled drugs and narcotics.

• Revises who counts as a wholesaler and what licences are needed to handle controlled drugs, narcotics or drugs containing cannabis. It clarifies that some activities require a dealer’s licence under the Controlled Substances Regulations or a licence under the Cannabis Act.

• Changes the Medical Devices Regulations so they exclude drugs listed in the schedules to the Controlled Substances Regulations and certain cannabis-containing drugs from some device rules.

• Changes the Precursor Control Regulations to:

  • Require specific licences or exemptions to produce certain controlled substances.
  • Update what background-check documents applicants must provide, including documents covering the past 10 years and from foreign police forces if someone lived abroad.
  • Alter internal wording and some licence conditions (technical and administrative updates).

• Strengthens security and loss/theft reporting rules for precursors and similar items:

  • Licence holders must report loss or theft to the minister within 72 hours of becoming aware.
  • Reported thefts must also be reported to police within 24 hours.
  • Pharmacists, practitioners and hospitals must report loss or theft of certain Class A precursors within 10 days.
  • Reports and related records must be kept for at least 2 years.
  • Some rules say reports cannot be used to incriminate the reporter except in limited criminal cases.

• Adds a specific chemical (3-oxo-2-phenylbutanamide, also called APAA) to a precursor list in the schedule.

• Comes into force on the same day the Controlled Substances Regulations come into force; if these amendments were registered after that day, they would come into force on their registration day.

Who's affected#

• Pharmacists, hospitals and health practitioners who handle controlled drugs, narcotics, precursors or drugs containing cannabis.
• Drug manufacturers, wholesalers and dealers who need licences to produce, distribute or deal with controlled substances and precursors.
• Licence applicants and current licence holders who must supply background-check documents covering the past 10 years and meet new security and reporting duties.
• Police and regulators who receive and act on loss/theft reports.
• Patients and caregivers may notice different labels or packaging on prescription or controlled-drug products.
• It is clear from the text which regulated businesses and health professionals are affected; the notice does not name any other groups.

Why it matters#

• The changes aim to make rules for controlled substances clearer and more consistent across different laws, especially where cannabis-containing drugs overlap with other controlled drugs.
• They increase security and faster reporting for lost or stolen precursors and controlled substances, which is meant to reduce the risk that those chemicals are diverted into illegal drug production.
• Businesses and health-care providers that handle these drugs will likely face new paperwork, record-keeping and reporting duties. That can mean more compliance time and possibly new costs.
• For people taking prescription or controlled drugs, the most visible effects are likely clearer labels and sometimes different packaging.