DEA takes some CBD off Schedule 1 – with FDA approval

Epidiolex DEA, DEA takes some CBD off Schedule 1 – with FDA approval

(This story has been updated to provide additional details from the DEA announcement.)

The U.S. Drug Enforcement Administration has taken some cannabidiol 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, a CBD preparation for rare types of epilepsy that is made from cannabis grown in the United Kingdom.

If the DEA had not taken this step, doctors would not have been able to prescribe the medication because Schedule 1 drugs cannot be prescribed. This rule is why physicians in states with medical marijuana laws recommend the plant but can’t prescribe it.

The change also means Epidiolex will be distributed through traditional pharmaceutical channels, from a doctor’s prescription to a drugstore, instead of through a marijuana dispensary or designated marijuana caregiver.

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. Other Schedule 5 drugs include Lyrica and prescription-strength Robitussin with codeine.

Cannabis entrepreneurs cheered 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.

London-based GW Pharmaceuticals, the manufacturer of Epidiolex, has said it will charge $32,500 a year for the treatment, in line with other medications for intractable epilepsy.

As a result, many patients likely will wait to see if insurance covers the drug, a decision usually driven by another federal agency, the Centers for Medicare and Medicaid Services. That agency determines what is included for recipients of federal health benefits.

Market opportunities and risk

The most intriguing potential for investors from the rescheduling is called off-label use – physicians prescribing a drug for other conditions besides the ones for which the drug manufacturer ran trials.

Epidiolex’s market opportunity may be much broader if doctors prescribe it to patients with other types of epilepsy under this standard.

The scheduling change also could make it easier for medical researchers to look at CBD applications beyond epilepsy treatment.

“Continuing to study the benefits of CBD would increase the number of practical uses for the compound,” Michael Brubeck, CEO of Centuria Natural Foods, wrote in an email to Hemp Industry Daily.

He noted that several other CBD medications are in the pipeline for FDA consideration and that Epidiolex is “paving the way for more cannabinoids following the same regulatory channel to market.”

The FDA said Thursday that the approval process won’t change for other cannabis medications based on the CBD rescheduling. In other words, things won’t necessarily get easier for other companies proposing FDA-approved cannabis medicines.

Shares of GW Pharmaceuticals, which trades on the Nasdaq as GWPH, closed at $174.50 Thursday, an increase of almost 7% and a record high for a cannabis stock on any exchange.

Rescheduling brings some risk for other CBD manufacturers and retailers.

GW Pharmaceuticals has repeatedly said it has no objection to other companies making CBD, but many in the cannabis industry fear the company and the U.S. Food and Drug Administration may try to block other formulations of the extract.

Acetaminophen, for example, is perfectly legal over the counter, but it’s not legal to make at home and then sell.

A few states, including South Dakota, have laws on the books that favor CBD products with FDA approval.

“It could really be a burden to the medical sector if the FDA becomes involved,” said James Minutello, CEO of Leaf Logix, a Glendale, California, company that makes business management software for the cannabis industry.

Still, the rescheduling is a long-awaited improvement, he said.

“We’re one step closer to finally ending prohibition and legitimizing the industry,” Minutello said.

21 comments on “DEA takes some CBD off Schedule 1 – with FDA approval
    • Farid Ghehioueche on


      Hashtag: #CannabiSDG

      December 5-6-7th 2018, the UN Commission of Narcotic Drugs (CND), the only United Nations body dealing with Cannabis policy, will receive the final scheduling recommendations of the World Health Organization (WHO) on cannabidiol (40th ECDD) and cannabis in all forms (41st ECDD). These recommendations will be presented to the 187 Member States at the United Nations Office on Drugs and Crime (UNODC) headquarters in Vienna, Austria.

      This CND gathering will be the final global meeting before the Highest-Level UN Session on drug policy (March 2019) where new Cannabis Treaty scheduling and the 2019-2029 plan of action will be voted by the Countries. These decisions will offer opportunities for countries to develop innovative policies and new market perspectives.

      The International Cannabis Policy Conference, December 7-9th 2018 is the last opportunity for external inputs from key stakeholders: researchers, NGOs, students, public officials, policymakers, private sector businesses, investors, and all other interested parties – on this very crucial issue.

      Besides scheduling controls, this event presents the contribution of cannabis & industrial hemp markets and products innovations relevant to the achievements of the 2030 UN Sustainable Development Goals (SDG), a global framework for sustainable societies.

      The International Cannabis Policy Conference includes sessions with top research, industry and policy leaders and an exposition hall showcasing related food, products and services.

      Don’t miss the opportunity to be a part of the future of international cannabis policy right where changes happen.

  1. Rod Kight on

    To be clear, the DEA rescheduled Epidiolex, not cannabidiol (CBD). The Controlled Substances Act (CSA) does not list- nor has it ever listed- CBD on any of its schedules. CBD is only unlawful when it is derived from marijuana. Epidiolex contains CBD derived from marijuana, thus requiring rescheduling in order to be prescribed. However, CBD derived from a lawful source is lawful and is not scheduled.

        • Les on

          CBD is in Flaxseed too, it’s not a unique cannabinoid to marijuana. In fact CBD is not endocannabinoid specific at all, it doesn’t even induce a cannabinoid receptor and make a psychoactive effect. The scheduling is ridiculous for Hemp and is why no one is listening to the FED theses days. No one cares for their cannabis laws, and never will.

      • Bonnielee Ferrell on

        If hemp is schedule I then how can we have it used in so many products such as foods, soaps and clothes to name a few?

    • Yudah on

      That’s great information about if Cbd is arrived from lawful it’s not scheduled.
      I had concern because I’m opening a cafe and we will be serving natural juices containing Cbd from hemp no THC so you saying that this is considered lawful?


    This is B******T and clearly plays to big pharma!! Legality dependent on a prescription!! Give me a break! Leave our HEMP CBD ALONE Pass the dam 2018 FARM BILL to allow HEMP to be grown everywhere and to help with the dam drug companies!!

  3. Rafil Yunusov on

    Not everyone has the opportunity to get FDA approval! What should be done to those companies that do not have money for research, but which are already curing non-treatable diseases ??? For example, today we were able to develop a natural drug that can reverse cirrhosis of the liver and remove the hepatitis B virus. You can see the number of patients in Wikipedia. We give a guarantee of treatment or a refund, I am sure it says a lot.
    But we do not have huge funds for research, so we sell our medicine without registration.
    We will consider all partnership proposals for introducing to the market [email protected] .

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