- The U.S. Drug Enforcement Administration (DEA) ruling enables physicians to prescribe Epidiolex, a non-synthetic cannabis-derived medicine from United Kingdom-grown cannabis
- Cannabis entrepreneurs applaud the decision, even though it only applies to that specific drug; DEA decision requires approval of medications by the U.S. Food & Drug Administration (FDA)
- Several other CBD medications are in the pipeline for consideration by the FDA; move is seen as legitimizing the industry and changing it to traditional distribution of prescription-to-drug store
The DEA decision to approve the first non-synthetic CBD-derived drug, Epidiolex, and remove it from the agency’s most restrictive class of controlled substances is seen as having a positive impact on the cannabis industry and altering its channel of distribution, according to an article in the Hemp Industry Daily (http://ibn.fm/Nac4g). It is the first time that the agency has removed any type of cannabis from Schedule I.
The DEA has reclassified ‘finished dosage formulations’ of CBD and FDA-approved drugs that contain cannabis-derived CBD and less than 0.1 percent tetrahydrocannabinol (THC) as Schedule V. The decision comes after the FDA’s initial approval of the non-synthetic CBD-based drug to treat rare cases of epilepsy, the article notes.
Epidiolex has been rescheduled from Schedule I to Schedule V of the Controlled Substances Act. It was the first plant-based cannabis drug to be approved by the FDA. The most significant part of the decision is that the drug can be distributed through traditional pharmaceutical channels to patients based on a prescription from a doctor. It also means that the odds of successful commercialization of cannabis-based therapeutics have been greatly increased, both in the U.S. and globally, per the article.
ETST (OTCQB: ETST), a marketer of high purity and high grade full spectrum cannabidiol (CBD), believes that once the DEA’s decision goes into effect, it will be easier for companies to plan clinical studies with CBD. It also emboldens ETST’s strategy of becoming a licensed distributor that plans to work closely with researchers and pharmacists to serve the growing cannabis market (http://ibn.fm/d5WKH).
James Minutello, CEO of Leaf Logix, a Glendale, California, company that manufactures business management software for the cannabis market, stated in the article, “We’re one step closer to finally ending prohibition and legitimizing the industry.”
