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January 4, 2019

DEA takes some CBD off Schedule 1 as Aphria & Aurora Push Into US Market.

President Trump has officially signed the farm bill that includes a section that legalizes the commercial cultivation of hemp nationwide. From this, there is much speculation as to how the legalization of industrial hemp will affect the treatment of CBD by multiple government agencies, including the United States Patent and Trademark Office. Will the legalization of industrial hemp open the door for the DEA to take all CBD off Schedule 1 status? Not so fast…

The U.S. Drug Enforcement Administration has taken some CBD off the most restrictive class of controlled substances, a move that allows the sale of the first nonsynthetic, cannabis-derived medicine to win federal approval.

The agency announced Thursday that drugs including

finished dosage formulations of CBD with THC below 0.1% will be considered Schedule 5 drugs, as long as the medications have been approved by the U.S. Food and Drug Administration.

It is the first time the agency has removed any type of cannabis from Schedule 1. The action came three months after the FDA approved Epidiolex, as Epidiolex is the only FDA-approved CBD-based drug, which was rescheduled to Schedule V of the Controlled Substances Act (CSA) in September.The rescheduling affects more than Epidiolex. Here are the details from the announcement:

The DEA said the new scheduling applies to “FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1% tetrahydrocannabinols.” So even though Epidiolex is the only formulation that currently meets the definition, the change could eventually affect other CBD formulations.

It’s still not legal to make CBD in the U.S. The DEA said “the bulk cannabis material used to make the Epidiolex formulation (as opposed to the FDA-approved drug product in finished dosage form) will remain in Schedule 1.”

A Schedule 5 drug is still illegal without a prescription. The DEA says Schedule 5 drugs have a low potential for abuse and are generally pain relievers and antidiarrheal medications.

What Does This Mean For Marijuana Stocks?

The 2 main Cannabis companies who will benefit from this actually come from Canada, as Aphria & Aurora Push Into US celebrated a victory with the new classification, even though it currently applies to only one drug for rare diseases and has a price tag that may limit the market.

Emerging Cannabis companies like CBD of Denver, (OTC:CBDD) who are in the initial stages of their CBD expansion, are looking to capitalize on the U.S. Drug Enforcement Administrations recent shift in taking some CBD off the most restrictive class of controlled substances, which will allows the sale of the first nonsynthetic, cannabis-derived medicine to win federal approval.

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