Health Canada Approves First Special Access Program Requests for Psilocybin - TheraPsil

This page summarizes the first known use of Canada’s Special Access Program for psilocybin after the Food and Drug Regulations were amended on January 5, 2022. It describes how Dr. Valorie Masuda received authorization to treat six patients experiencing end-of-life distress with psilocybin and psychotherapy. The article explains the role of supporting organizations and contributors, including donated GMP synthetic psilocybin from Psygen Labs Inc. and access to an investigators' brochure from Apex Labs Ltd. It also notes that some patients were referred by TheraPsil and that Dr. Masuda prepared and filed requests after section 56 exemptions were denied or unanswered. The page is written for patients, prescribers, and others interested in legal access pathways for psilocybin in Canada. It also references the broader advocacy context around regulated access and ongoing treatment options.