Recently, the FDA announced the approval of a non-synthetic cannabis drug – Epidiolex – used to treat seizures. The FDA previously approved drugs only using synthetic THC, such as Marinol, Sydros, and Cesamet. But Epidiolex is the first drug derived from marijuana and approved by the FDA.
In preparation for the approval process, the manufacturer of Epidiolex conducted clinical trials on the potential abuse of cannabidiol (CBD), which is considered when classifying a drug into a controlled substance schedule. Prior to the approval of Epidiolex – and up until now – all substances derived from marijuana (including CBD) were classified as Schedule I. So when Epidolex was approved, the DEA faced a dilemma: it is a marijuana product but it is approved by the federal government acknowledging its beneficial use and low probability of abuse. By the way, the drugs with synthetic THC were classified as Schedule II-III.
Today (October 1, 2018), the DEA announced that it is classifying approved CBD drugs (Epidiolex) as Schedule V (!) drug – an unpredicted and a bold step towards legalizing marijuana products. The DEA defined approved CBD drugs as:
“A drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol . . . derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols.”
What does this mean for pharmacies?
The pharmacies may now carry CBD products but only if they are approved by the FDA and have less than .1% THC. So far Epidiolex is the only drug that fits into the description. Therefore, CBD oils, tinctures, etc. cannot be legally distributed by pharmacies as they constitute non-approved products derived from marijuana. State laws may vary but they usually permit the sale of marijuana CBDs only through the state regulated dispensaries – not pharmacies (unless they are located in Connecticut).
How about Hemp-CBD? Can a pharmacy carry such products?
Hemp is not a Scheduled I substance as industrial hemp was legalized in 2014. Therefore, arguably Controlled Substances Act does not apply to hemp products. However, Hemp-CBDs have not been approved by the FDA and therefore do not fit within the DEA’s narrow definition of “approved CBD drugs.”
For an excellent discussion on Hemp-CBD regulations and likely DEA enforcement actions against Hemp-CBD distributors, see Harris Bricken’s blog post.