On Thursday, September 27, 2018 the Drug Enforcement Administration (DEA) filed a rule, which was officially published on September 28, 2018, that placed certain FDA-approved medications containing cannabinoids in Schedule V, allowing them to be sold to the public here in the United States. Schedule V drugs are deemed to have the lowest level of abuse and face the fewest restrictions under the Controlled Substances Act (CSA); for example, cough syrup is in this category. Moving these medications to Schedule V means they will be available with a prescription to people who need it, though this won’t be cheap.
Specifically, the DEA’s rule applies to a formula created by UK-based GW Pharmaceuticals called Epidolex, which was recently granted approval by the US Food and Drug Administration (FDA) on June 25, 2018 and has been effective in treating epilepsy. Epidiolex is the first FDA-approved medication containing botanical cannabis. Medications containing synthetic cannabinoids, such as Marinol, were approved by the FDA in the 1980s and are listed in Schedule II or Schedule III (depending on the medication). The DEA’s new action marks the first time that any medication containing naturally-occurring cannabinoids, such as cannabidiol (CBD) and delta-9-tetrahydrocannibinol (THC), has been placed in anything other than Schedule I, the most restrictive category.
As noted above, the DEA’s rule is specific to the Epidiolex formulation. Thus, it only covers that specific drug, as well as future generic versions with the same formulation. GW Pharmaceuticals has obtained five different patents related to Epidiolex, which are set to expire in 2035 with the possibility that some will be eligible for an additional patent term. The DEA notes:
“As further indicated, any material, compound, mixture, or preparation other than Epidiolex that falls within the CSA definition of marijuana set forth in 21 U.S.C. 802(16), including any non-FDA-approved CBD extract that falls within such definition, remains a schedule I controlled substance under the CSA. Thus, persons who handle such items will continue to be subject to the requirements of the CSA and DEA regulations relating to schedule I controlled substances.”
83 Fed. Reg. 189, 48952 (Sep. 28, 2018).
In issuing this rule, the DEA added a new subsection (“(f) Approved cannabidiol drugs”) to the part of the Code of Federal Regulations containing the CSA’s scheduling list:
“1308.15 Schedule V
(f) Approved cannabidiol drugs.
(1) A drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol (2-[1R-3-methyl-6R-(1-methylethe nyl)-2-cyclohexen-1-yl]-5-pentyl1,3-benzenediol) derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydro cannabinols.”
21 CFR §1308.15(f).
While the rescheduling is specific to this formula, many people and businesses are hoping that this signals a shift in the federal government’s stance towards CBD products – and ultimately cannabis – in general.
The California Department of Public Health (CDPH) recently published an FAQ about Industrial Hemp and CBD in Food Products in which CDPH essentially deferred to the federal government’s position, stating that “[u]ntil the FDA rules that industrial hemp-derived CBD oil and CBD products can be used as a food or California makes a determination that they are safe to use for human and animal consumption, CBD products are not an approved food, food ingredient, food additive, or dietary supplement [in California].”
The Los Angeles County Department of Public Health recently issued its own statement regarding Industrial Hemp and CBD products stating that “[e]ffective July 1, 2019, prohibited use of industrial hemp derived products in food will be considered adulterated and cited by DPH-EH as a violation resulting in a deduction of two (2) points on the official inspection report.”
In response to the DEA’s rescheduling announcement, stock prices for GW Pharmaceuticals rose dramatically, reaching a new record high of $179.65.
The takeaway from the DEA’s rescheduling announcement is that the Schedule V reclassification is specific to GW Pharmaceuticals’ Epidiolex, and does not, contrary to popular misconception, apply to any and all CBD products.
Now that Epidiolex is a Schedule V controlled substance, it would be in the best interests of GW Pharmaceuticals to make it widely available and affordable. Given that health care providers are generally allowed to prescribe medications for off-label use, it would not be surprising if plant-based CBD prescription medications such as Epidiolex replace other prescription drugs.
The above information is provided as a public service. It is not intended as legal advice.
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