Federal regulationCanada Gazette, Part IComment Period Closed
Controlled Substances Regulations
Sponsoring body: Health, Dept. ofIntroduced June 1, 2024Last checked August 25, 2026
Read the official text on gazette.gc.caOfficial version — Canada Gazette, Part I
What this regulation does
The Controlled Substances Regulations (CSR) consolidate five existing sets of regulations and six class exemptions into a single, unified framework governing legitimate activities with all categories of controlled substances — narcotics, controlled drugs, targeted substances, and restricted drugs — conducted by licensed dealers, pharmacists, practitioners, hospitals, and individuals.
Plain-language summary by Legisail.
Business impact
Compliance
About 19,774 businesses are affected, with 98% classified as small businesses — including licensed dealers (approximately 343 at launch, growing by ~12 per year), pharmacies, cannabis licence holders, and test kit registration holders. The biggest change for pharmacies is that central fill services for controlled substances no longer require a dealer's licence, saving roughly 80 pharmacies an estimated 20 hours each in licensing and reporting burden worth $1.46 million in present value; pharmacy technicians also gain independent authority to compound, deliver, and destroy controlled substances. Licensed dealers get a simpler loss-reporting process (no longer required to report unexplained losses to police, only to Health Canada) but must now record additional information like drug identification numbers and names of individuals involved in transactions, costing about $24,551 per year collectively. The average net cost to a small business is only about $17 per year, with average savings of $23 per year, resulting in a net benefit per small business of roughly $7 annually.
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Where this regulation is
Proposed
Comment period closed
Final publicationPending
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