DEA Reschedules CBD-Based Drug to Schedule V
According to a report from CNBC.com (1), the U.S. Drug Enforcement Administration (DEA) has rescheduled GW Pharmaceuticals’ cannabidiol (CBD)-based drug, Epidiolex, to schedule V.
According to a report from CNBC.com (1), the U.S. Drug Enforcement Administration (DEA) has rescheduled GW Pharmaceuticals’ cannabidiol (CBD)-based drug, Epidiolex, to schedule V.
The U.S. Food and Drug Administration (FDA) approved Epidiolex in June 2018, as an oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy-Lennox-Gastaut syndrome and Dravet syndrome-in patients two years of age and older (2,3). The FDA’s approval of Epidiolex forced the DEA to consider how to classify it since cannabis is considered a schedule I drug, which is defined as having no currently accepted medical use and a high potential for abuse. Epidiolex will be classified as a schedule V controlled substance, which is the lowest level, defined as those with a proven medical use and low potential for abuse.
According to the CNBC report, the rescheduling applies to CBD containing no more than 0.1% tetrahydrocannabinol (THC), in FDA-approved drug products. This allows GW Pharmaceuticals to sell Epidiolex, but it does not broadly apply to all CBD products.
For more information on the descheduling, please read the full report from CNBC (1).
References:
- https://www.cnbc.com/2018/09/27/dea-schedules-epidiolex-allowing-gw-pharma-to-start-selling-the-drug.html
- https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm?utm_campaign=06252018_PR_FDA%20approves%20marijuana-derived%20drug%20to%20treat%20two%20forms%20of%20epilepsy&utm_medium=email&utm_source=Eloqua
- http://www.cannabissciencetech.com/news/fda-approves-first-drug-containing-cbd
Ep 24, Part III: Data Transparency in Cannabis Testing with Yasha Kahn
December 26th 2024In the final part of this episode, Evan Friedmann and Yasha Kahn discuss the need for a national entity to centralize cannabis data collection, moving from snapshot data to continuous updates. They emphasize the importance of accurate lab data and adverse event tracking, suggesting QR codes on packaging to report issues. Yasha suggests harsher consequences for result manipulation and suggests collaboration between state departments and federal entities to support underfunded regulators. They also discuss the potential benefits of off-the-shelf testing and the importance of stability testing. Finally, Yasha shares his top three reading recommendations for the audience.
Ep 24, Part II: Data Transparency in Cannabis Testing with Yasha Kahn
December 12th 2024Evan Friedmann and Yasha Kahn, co-founder of MCR Labs, discuss the discrepancies between current regulations and data on mycotoxins and pesticides in cannabis products. They highlight the need for updated regulations based on new data, emphasizing the importance of accurate testing and labeling. They also discuss the issue of result manipulation, particularly in THC content, and the need for public health officials to address this. Yasha suggests making testing data public to enhance oversight and suggests a national entity to manage this data for better consistency and public safety.
