Although a small number of marijuana-inspired drugs like Marinol have previously been approved by the FDA, these medications only contain synthetic, lab-created cannabinoids. Epidiolex, on the other hand, contains CBD derived from actual cannabis plant material. The DEA has previously classified all forms of CBD as Schedule I drugs with no medical value, but now that Epidiolex has been approved by the FDA, the DEA must reschedule this medicine as a Schedule II or lower drug by the end of September.

There are currently around 1,200 patients in the U.S. who are currently receiving Epidiolex as part of the FDA trials that eventually led to the drug’s approval, but that number is set to expand when the drug is officially released this fall. “We expect to make Epidiolex available to U.S. patients this fall, following rescheduling, which is expected to occur within 90 days of FDA approval,” Gover said, according to the Philadelphia Inquirer. “We have been building commercial inventory in recent months and are in a position to ship product into the U.S. supply chain, once rescheduling is complete.”