Modernized Controlled Substances Regulations

Summary#

These are the new federal Controlled Substances Regulations (SOR/2025-242). They bring together and modernize rules about who may make, move, sell, import, export, store, destroy or test drugs that are listed as controlled substances, and they take effect on October 1, 2026. The rules also repeal several older instruments and fold some temporary exemptions into permanent regulatory text.

What it does#

• Consolidates and replaces older rules, including the Narcotic Control Regulations, the Benzodiazepines and Other Targeted Substances Regulations, Parts G and J of the Food and Drug Regulations, the New Classes of Practitioners Regulations, and certain class exemptions, into the single Controlled Substances Regulations.
• Keeps the dealer licence and import/export permit system but updates how licences, permits and changes are handled (approval, renewal, suspension and revocation).
• Changes reporting and record-keeping:
  • Moves routine reporting to monthly reports (aligns regulation with current practice).
  • Requires more specific records (for example, drug identification numbers for some finished products).
  • Requires licensed dealers to get approval before changing their record-keeping method.
• Makes practical changes for health care and pharmacies:
  • Explicitly allows a pharmacist to substitute one prescribed controlled substance for another (therapeutic substitution) if the pharmacist is allowed to do so under the provincial rules.
  • Authorizes many pharmacy technician activities (e.g., compounding, transporting and some destruction) consistent with their provincial scope of practice.
  • Makes it easier for pharmacies to provide “central fill” services (one pharmacy fills a prescription for another).
  • Formalizes rules for accepting and destroying patient returns (post‑consumer returns) and allows more places (including hospitals, clinics and certain municipal facilities) to hand returns to licensed dealers or other authorized parties for destruction.
• Updates import/export and travel rules:
  • Allows an individual to import or export up to a 90-day supply of prescribed controlled substances for personal or accompanying-animal use when travelling, subject to labeling and declaration rules.
• Changes test‑kit rules:
  • Simplifies how test‑kits that contain a controlled substance are registered and lets holders notify Health Canada of certain changes instead of getting a new registration number.
• Adds a new approach for government forensic/toxicology labs so they can do many activities without a dealer licence (they still need import/export permits).
• Gives the federal Minister clearer authority to share factual information with provincial governments and professional regulators, and to temporarily schedule substances when needed.
• The regulatory impact statement reports a net present-value benefit of $0.62 million over 10 years.

Who's affected#

• Licensed dealers (companies that produce, package, import, export, sell or destroy controlled substances).
• Pharmacists and pharmacy technicians (including rules that distinguish community pharmacies from hospital pharmacies).
• Practitioners (doctors, dentists, veterinarians and the prescribed categories such as nurse practitioners, midwives, podiatrists).
• Hospitals and their pharmacy operations.
• Government laboratories that do forensic or toxicology testing.
• Individuals / travellers who need to carry prescription controlled substances across borders.
• Municipal waste facilities or other “particular persons” that unexpectedly receive drugs for disposal.
• Health Canada (implements, inspects and enforces the rules) and provincial professional regulatory authorities (which decide whether pharmacists may do therapeutic substitution in their province).

If it’s unclear who is affected in a specific case (for example, whether a particular pharmacy activity requires a dealer licence in one situation), the rules give Health Canada a role to approve or clarify.

Why it matters#

• Easier to understand: the government has put many scattered rules into a single modern regulation so businesses, pharmacies and doctors have one place to look.
• Practical effects for patients:
  • More ways to get a needed medicine (e.g., pharmacy central fill, therapeutic substitution where provinces permit).
  • Travellers can carry a larger supply for medical needs (up to 90-day supply) when rules are met.
  • Clearer, legally backed options for safely returning unwanted medicines to pharmacies, hospitals or approved waste facilities.
• Operational effects for businesses and health services:
  • Some administrative changes and new record-keeping or notification steps are required. Health Canada estimates overall net benefits but also expects modest compliance costs for establishments to adjust.
• Timing: the regulations come into force on October 1, 2026, so affected organizations have time to prepare.