The DEA Finalizes Approval For Synthetic Cannabis
The U.S. Drug Enforcement Administration (DEA) has approved a synthetic form of THC (tetrahydrocannabinol) as a Schedule II controlled substance. THC, an active component in Cannabis that makes people have the “high” feeling. Examples of other Schedule II substances include hydrocodone, oxycodone, cocaine and other drugs that have an accepted medical use except having a high potential for abuse.
The move is the final regulatory obstacle for dronabinol (Syndros), an oral solution prescribed for the medication of nausea and vomiting for chemotherapy patients, and as an appetite stimulant for AIDS patients.
The DEA quietly announced the scheduling of dronabinol in a notice published in the Federal Register right before Thanksgiving day. The agency adopted an interim rule classifying dronabinol as a Schedule II substance in March while the Food and Drug Administration (FDA) approved a new drug application for dronabinol in July, recommending that the DEA to finalized its rule.
Dronabinol As A Schedule II Substance
While real cannabis continues to be illegal under federal law and classified as a “dangerous” Schedule I substance, the classification of dronabinol as a Schedule II substance means that a synthetic version of cannabis can legally be prescribed across the country, excluding the 29 states in the US and the District of Columbia as medical cannabis is legal.
Dronabinol, sold under the brand named Syndros by Insys Therapeutics, is an Arizona drug maker beset by accusations that another one of its products called Subsys, is responsible for hundreds of overdose deaths. Syndros is similar to Marinol, another medication derived from cannabis that’s in pill form. The DEA has been aggressively going after several company officials, and doctors who’ve prescribed Subsys and accepted speaking fees from Insys and charging them with fraud, racketeering and kickback charges.
Ironically, the DEA’s action also gives Insys the exclusive right to manufacture and sell its liquid formulation of dronabinol without worrying about any competition. Any other synthetic version not sold as Syndros will still be considered as a Schedule I substance.
“It should be noted as a preliminary matter that any form of dronabinol other than in an FDA-approved drug product remains a schedule I controlled substance, and those who handle such material remain subject to the regulatory controls, and administrative, civil, and criminal sanctions, applicable to schedule I controlled substances set forth in the CSA (Controlled Substance Act) and DEA regulations,” said the DEA.
“According to Healthcare Bluebook, a one-month supply of Syndros will cost about $2,000 at major pharmacy chains. A “fair price” for Syndros is listed as $1,000.
Insys Therapeutics drew the ire of marijuana advocates last year when it donated $500,000 to a campaign against the legalization of marijuana in Arizona.
The company is worried about the medical use of “natural cannabis,” but has petitioned the DEA to reschedule another synthetic cannabidiol (CBD) that is derived from marijuana from Schedule I to Schedule IV.” – Pat Anson (Editor)
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Published on February 9th, 2018
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