The Food and Drug Regulations sit under the Food and Drugs Act and run to hundreds of sections. Part C, Division 5 covers drugs for clinical trials involving human subjects: section C.05.003 says no one may sell or import a drug for a clinical trial unless authorized under that Division (Justice Laws, FDR). Health Canada says psilocybin trials are authorized under that Division (Health Canada, magic mushrooms).
Section C.08.010 lets the Minister issue a letter of authorization to a manufacturer to sell a specified quantity of a new drug to a practitioner for emergency treatment (Justice Laws, FDR). That is the legal basis of the Special Access Program.
Parts G and J of these regulations used to govern controlled and restricted drugs. The Controlled Substances Regulations consolidated them into a new set that came into force on 1 October 2026 (Canada Gazette, SOR/2025-242). The consolidation we read was current to 30 September 2026. Not legal advice.
General information, not legal advice.
Sources
- Justice Laws: Food and Drug Regulations
- Health Canada: Magic mushrooms
- Canada Gazette Part II: SOR/2025-242
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