Canadian marijuana producer MediPharm Labs said it completed a shipment of cannabis oil containing both CBD and THC to the United States for use in a clinical trial.
While shipping cannabis to the United States for scientific use isn’t unusual, MediPharm said in a news release that this marks the first time a cannabis product has been sourced from a Canadian licensed producer for a Phase 2 clinical trial in the U.S.
The release said the trial is being funded by the U.S. National Institutes of Health in Bethesda, Maryland, but did not reveal who was conducting the trial.
The delivery occurred July 28.
In a news release, MediPharm said the export process relied on:
- Its Drug Establishment License and product stability data.
- The United States’ Innovative New Drug Approval.
- U.S. Drug Enforcement Administration import approval.
MediPharm said steps to meet those requirements were years in the making and involved significant capital investments.
“This development is significant as the majority of cannabis operators in the US are operating under state specific regulations that prohibits them from manufacturing for FDA sanctioned research activities and DEA approved shipments under federal narcotic laws,” MediPharm’s release noted.
MediPharm, which is aiming to be a leader in the development and production of pharmaceutical cannabinoids, said it completed a five-day, in-person inspection by the U.S. Food and Drug Administration last November – the first of its kind for a cannabis facility in Canada.
MediPharm’s shares trade as LABS on the Toronto Stock Exchange.