Canadian Study: Health Canada Conducts Fourth Pharmacy Inspection

On October 30, 2012, Health Canada conducted its fourth inspection of the pharmacy where the MDMA will be stored for our planned Canadian study of MDMA-assisted psychotherapy for PTSD. We are now required to implement one additional upgrade to the pharmacy alarm system. The fifth and (we hope) final inspection is scheduled for November 8.

New security regulations created after the initial inspection has required us to make numerous expensive changes to the pharmacy, including hiding the safe with a wooden cabinet, moving the safe and cabinet to a new room with a solid (rather than glass) door, installing multiple new alarm systems, adding bulletproof polycarbonate over the windows, and placing additional warning labels on the study drug. Once Health Canada grants the Controlled Substances License we will know whether we will be able to import the MDMA into Canada and initiate the study, or if there will be further delays.