Proposed Controlled Substances Regulations

Summary#

This is a proposal by Health Canada to replace several existing rules with a single set called the Controlled Substances Regulations under the Controlled Drugs and Substances Act. If adopted, it would harmonize licences, record‑keeping and authorizations for narcotics, controlled drugs, targeted substances and restricted drugs, and make practical changes for pharmacies, researchers and people who travel with prescriptions.

What it does#

• Consolidates and replaces 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 some class exemptions into one new regulation: the Controlled Substances Regulations.
• Brings authorizations that were previously handled by temporary class exemptions into the new regulations so those activities are explicitly allowed.
• Changes for pharmacies and pharmacy staff:
  • Lets pharmacy technicians independently perform many non‑prescribing tasks with controlled substances (compounding, sending, transporting, destroying, transferring prescriptions), while pharmacists would remain the only ones allowed to sell or provide controlled substances.
  • Formally allows patient‑specific “central fill” services between pharmacists without the pharmacy having to hold a dealer’s licence.
• Travel and personal possession:
  • Authorizes individuals to import or export up to a 90‑day supply of a prescribed drug that contains a controlled substance when entering or leaving Canada (up from 30 days in some cases).
• Licensed dealers and reporting:
  • Requires licensed dealers to report unexplainable losses only to Health Canada (not to police), while thefts still must be reported to both police and Health Canada.
  • Changes routine reporting from annual to monthly to match current practice.
  • Adds some extra information required on import/export permit applications (e.g., port of entry/exit, mode of transport).
• Research and test kits:
  • Removes the separate Part J research authorization for restricted drugs; researchers would use subsection 56(1) exemptions to obtain restricted drugs, aligning procedures across categories.
  • Simplifies test‑kit registration changes: holders would notify the Minister of certain modifications instead of applying for a new registration number.
• Schedules and specific substances:
  • Keeps separate Schedules for narcotics, controlled drugs, targeted substances and restricted drugs.
  • Proposes adding bezitramide and piritramide to the narcotics schedule (noting Health Canada says these are not currently used in Canada).
• Drafting, timing and next steps:
  • This is a proposal open for comment for 60 days from its publication on June 1, 2024. The draft says the final regulation would come into force 365 days after it is published in Canada Gazette, Part II if adopted.
• Consequential changes:
  • Would trigger amendments to the Cannabis Regulations, Precursor Control Regulations, Food and Drug Regulations and certain fee regulations to keep cross‑references consistent.

Who's affected#

• Pharmacists and pharmacy technicians — changes to who can do which tasks, and new or clarified record‑keeping rules.
• Licensed dealers (producers, distributors, importers, exporters) — licence, permit and reporting changes.
• Practitioners (doctors, dentists, veterinarians, nurse practitioners, midwives, podiatrists) and hospitals — harmonized authorizations for prescribing, administering and handling controlled substances.
• Researchers who work with restricted drugs — different authorization pathway.
• Holders of test‑kit registration numbers — simplified change notifications.
• Travellers who carry prescribed controlled substances — the higher personal‑possession allowance (up to 90 days) affects them directly.
• Health Canada — will administer the single consolidated regulation and expects to change how it processes some applications and inspections.
• Small businesses: the proposal estimated about 19,774 small businesses would be affected (pharmacies, small licensed dealers, etc.).

Costs and benefits estimated by Health Canada (these are the department’s estimates for the proposal, not a guarantee of outcome):

• Over 10 years: estimated monetized benefits $4.85 million (present value) and costs $4.09 million (present value), for a net benefit of $0.76 million (present value). Annualized net benefit is about $108,346.

Why it matters#

• Simpler rules: putting similar rules for all controlled substances into one modern document is meant to reduce confusion for pharmacies, dealers, researchers and regulators.
• Practical day‑to‑day effects:
  • Pharmacy technicians may be able to do more on their own, which could speed up pharmacy work and free pharmacists for clinical tasks.
  • Central fill services become easier to run without a dealer’s licence, which can save time and cost for pharmacies that use that model.
  • Travellers and people with chronic conditions may find it easier to travel with enough medication thanks to the 90‑day allowance.
• Trade‑offs:
  • Some parties will face new or clearer record‑keeping and notification duties. Health Canada estimates there are small overall costs from those requirements, partly offset by savings from reduced paperwork in other areas.
• Not final yet:
  • This is a proposed regulation. It’s open for public comment for 60 days from June 1, 2024. It would only become law if finalized and then published in Canada Gazette, Part II, followed by the stated transition period.