Not to be content with being the first approved CBD-derived drug for treatment of epilepsy, GW Pharmaceutical’s Epidiolex is causing the Drug Enforcement Agency’s stance on cannabis to change. Epidiolex’s rescheduling is the first time in 46 years that the DEA is shifting a Schedule I substance derivative to a lesser regulated level according to Leafly.
The DEA’s change of stance is a landmark event for a few reasons: Epidiolex is a pioneer, and hopefully is the beginning of a slew of clinical trials relating to cannabis. Secondly, researchers believe the drug’s approval is a key to getting their hands-on cannabis.
The Food and Drug Administration (FDA), with the permission of the DEA, is starting a new scheduling for CBD-based, approved drugs called Schedule V. It’s important to remember that CBD remains Schedule I, but those undertaking and succeeding in completing the lengthy FDA approvals process won’t have to worry about navigating the schedules of the Controlled Substances Act (CSA).
Cannaceuticals, a class of drugs relating to CBD and cannabis-containing drugs, are growing in popularity. Canada is leading the way regarding of the amount of clinical trials, but the rescheduling of Epidiolex is expected to attract more investors to the US sphere.
Researching in the US remains a bit of an albatross as states determine if they allow for cannabis, hemp, or CBD. Supporters of CBD and medicinal marijuana remain optimistic that Epidiolex’s approval paves the way for more alternative treatments.
The DEA, though always enforcing compliance with the CSA, is not planning on stymying researchers using hemp permissible under pilot programs.
For companies looking to capitalize on the medicinal green rush, we recommend implementing a pharmaceutical inventory control software to keep strict tracking and tracing of all materials. InstantGMP™ Track & Trace comes with all the Good Manufacturing Practices (GMPs) workflow built-in for complying with regulations. Getting ahead of the curve is essential, especially with investing the number of resources into drug approvals, as cannabis and CBD drugs should plan for needing to meet requirements for pharmaceutical regulations. In the meantime, InstantGMP Track & Trace is a great starting point and easily segues to a pharmaceutical grade system.