Canadian cannabis producer, MediPharm Labs, has exported oil which contains CBD and THC to the US to be used in a clinical trial.
MediPharm Labs, a Canadian cannabis producer, announced recently that they had exported a shipment of cannabis oil containing cannabidiol (CBD) and tetrahydrocannabinol (THC) to the US to be used in a clinical trial (1).
Shipping cannabis to the US isn’t uncommon for scientific usage. In a recent press release (2), MediPharm Labs unveiled that their cannabis oil export was not an ordinary shipment. It marked the first time that a cannabis product originating from a Canadian licensed producer was shipped for a Phase 2 US clinical trial.
In the press release, it mentioned that the Phase 2 trial was being funded by the US National Institutes of Health (NIH) in Bethesda, Maryland but did not specifically list who was in charge of conducting the clinical trial.
The export process relied on (1,2):
MediPharm Labs detailed that these requirements took time to be met and needed capital investments (2), “The complex process relied on MediPharm's GMP Drug Establishment License, product stability data, US FDA Innovative New Drug Approval, and US DEA narcotic import approval.Steps to meet these requirements were initiated five years ago and involved large capital investments, demonstrating a unique pharmaceutical capability and approach that distinguishes MediPharm from other cannabis companies.”
“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,” the release stated (2).
The Canadian cannabis producer is hoping to become a leader in the production and development of pharmaceutical cannabinoids. The business had to go through a five-day, in-person inspection by the US Food and Drug Administration (FDA) in November 2022, which was the first of its kind for a cannabis facility from Canada (1).