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Cannabis-derived, FDA-approved drug one step closer to patients with rare epilepsy disorders

Marijuana still considered Schedule I drug

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SAN ANTONIO – The Drug Enforcement Administration has moved U.S. Food and Drug Administration-approved drugs containing cannibidiol, or CBD, to Schedule V of the Controlled Substances Act.

The order places drugs that are FDA-approved and contain no more than 0.1 percent of tetrahydrocannabinol, or THC — the compound in cannabis that gives the user euphoric effects — in Schedule V, the DEA said.

“Now that Epidiolex has been approved by the FDA, it has a currently accepted medical use in treatment in the United States for purposes of the CSA,” the DEA said in its order.

Drugs in the Schedule V category include substances containing limited quantities of certain narcotics. The DEA said those drugs are generally used for antidiarrheal, antitussive and analgesic purposes.

The FDA approved the drug Epidiolex, an oral solution that contains CBD, for medical use in the United States to treat two rare forms of epilepsy for patients 2 years or older.

“Epidiolex no longer meets the criteria for placement in Schedule I of the Controlled Substances Act,” the DEA said in its order.

The rescheduling will allow GW Pharmaceuticals to possibly make Epidiolex​​​​​​​ available within the next six weeks.

“With this final step in the regulatory process completed, we are working hard to make EPIDIOLEX available within the next six weeks as we know there is excitement for a standardized version of cannabidiol that has undergone the rigor of controlled clinical trials and been approved by the FDA,” said Justin Grover, GW’s chief executive officer, in a news release.

While CBD is available as a supplement in many retailers around the Alamo City and across the U.S., the DEA still considers marijuana and its derivatives Schedule I drugs.

The state legislature is expected to discuss the issue of medical marijuana during its session next year.

Currently, the state’s Compassionate Use Act allows for some qualifying epilepsy patients to access treatment with no more than 0.5 percent THC.

“DEA will continue to support sound and scientific research that promotes legitimate therapeutic uses for FDA-approved constituent components of cannabis, consistent with federal law,” said Uttam Dhillo, acting DEA administrator. “DEA is committed to continuing to work with our federal partners to seek ways to make the process for research more efficient and effective.”

To read more about the DEA order, click here

To learn more about drug scheduling, click here.


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