Earlier this month, a well-known drug manufacturer
received word that a CBD-based medication will no longer be regulated under the
United States Controlled Substances Act.
Epidiolex, a medication made with CBD that is used to treat certain types of epilepsy, will now be marketed as a normal medication. While this is fantastic news, it’s also a bit confusing since CBD is already federally legal. While this announcement effectively removes CBD from the controlled substances act, much remains to be understood about how the U.S. regulates cannabidiol.
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The Initial Announcement
On Monday, April 6, GW Pharmaceuticals announced that the company had received notice from the DEA (United States Drug Enforcement Administration) stating that Epidiolex was no longer subject to the requirements of the Controlled Substances Act (“CSA”).
According to the statement
released by GW CEO Justin Gover, “This notification from DEA fully establishes
that EPIDIOLEX, the only CBD medicine approved by FDA, is no longer a
controlled substance under the federal Controlled Substances Act. We would like
to thank DEA for confirming the non-controlled status of this medicine.
Importantly, the descheduling of EPIDIOLEX has the potential to further ease
patient access to this important therapy for patients living with Lennox-Gastaut
Syndrome and Dravet syndrome.”
Epidiolex first launched in the United States in late 2018 and has since formed a market in 30 European countries and is currently undergoing clinical testing in Japan. It’s the first and only CBD-based drug to be approved by the FDA (United States Food and Drug Administration). This medication is used to treat the two aforementioned forms of epilepsy (Lennox-Gastaut Syndrome and Dravet syndrome), which are both extremely rare, severe, and debilitating.
Keep in mind that all non-Epidiolex CBD products are still illegal and will be regulated under the FDA Controlled Substances Act. The FDA has recently cemented their position on CBD, stating that cannabidiol’s safety profile has “not been established” and that and products containing the compound will be viewed as “adulterated and misbranded drugs”.
The FDA’s clarified stance on CBD is extremely contradictory, especially after they released a 27-page report nearly 2 years ago in which FDA officials argued (rather convincingly I might add), that CBD-use is associated with a very low risk profile.
From the report, “Upon
consideration of the eight factors determinative of control of a substance
under section 201 (c) of the CSA, FDA concludes that CBD and its salts … could
be removed from under the CSA… We reach this conclusion because we find that
CBD does not meet the criteria for placement in and of Schedules II, III, IV,
or V under the CSA.”
That said, GW is
wasting no time in updating their facilities and operations throughout their distribution
network. They will be look at this on a state-by-state basis and will begin
shipping Epidiolex to pharmacies and will possibly even have access to prescription
delivery though some insurance networks. The doors are certainly open wider for
the drug manufacturer now.
So, Is CBD Legal or
still all very confusing. Simply put, it’s legal but highly regulated. To
expand on that a little bit, we’ll have to take a look at the 2018 Farm Bill that
legalized hemp at the federal level and removed it from the controlled substances
act. But what is defined as hemp?
According to the FDA, hemp is defined as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
industrial and smokable CBD Flowers, are NOT regulated as controlled substances.
However, any manufactured product containing cannabis or hemp extracts (ie –
cannabinoids) still is. That means CBD-infused supplements, medications,
edibles, and cosmetics are still technically illegal unless they have been
subjected to FDA-approval, which is a tedious and costly endeavor.
This will remain
the same, the only difference is that now, Epidiolex can be manufactured and
sold as non-controlled substance. In the United States, most medications such
as those for blood pressure, diabetes, heart conditions, and other common
illnesses are not considered “controlled substances”. Medications that can
cause mental and physical dependence, like pain medications for example, are
regulated under the controlled subsantces act because there are restrictions on
the way these prescriptions can be filled and refilled.
The Silver Lining
Even though this
change only applies to Epidiolex, it goes without saying that it’s a testament
to the effectiveness of CBD-based therapies. The FDA and DEA have both officially
acknowledged that, yes, CBD can be used safely to treat certain health
restrictions on the way these prescriptions are filled means that patients will
have easier access to this medication. It will be easier to obtain and likely
cheaper. When a medication is regulated as a controlled substance, there are
certain requirements that are needed to fill and refill these prescriptions.
Patients will need to be a certain age, will need to have an ID, and the amount
of controlled-medications that can be prescribed each month is limited.
People will still
need to get a prescription from a licensed physician, but the prescription will
be valid for a year, it can be transferred between pharmacies, and state
reporting requirements will no longer apply.
Having CBD removed from the controlled substances act is a big deal. Even though it only applies to one medication (for now), it’s a step in the right direction. Things are at a bit of stand-still in most industries right now, but as more cannabis-medications go through clinical testing, there will be an influx of these easy-to-access CBD therapies on the market.
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