Washington, DC: The United States Drug Enforcement Administration (DEA) is considering reclassifying plant-derived THC, the primary psychoactive compound in marijuana, from schedule I to schedule III controlled substance under the federal Controlled Substances Act, according to a report published last week in The Daily Caller.
The agency first announced its proposed action in the Federal Register on November 1, 2010, stating its intent to "expand the schedule III listing to include formulations having naturally-derived dronabinol and products encapsulated in hard gelatin capsules."
The DEA presently defines dronabinol as synthetic THC in sesame oil and encapsulated in a soft gelatin capsule in a US Food and Drug Administration (FDA) approved product.
The November 1, 2010 DEA announcement states that the agency has received four petitions from companies wishing to potentially bring products to market containing "naturally-derived or synthetically produced dronabinol." Those products, if approved by the FDA, would be marketed as generic alternatives to Marinol, which has been legally available in the United States by prescription since 1985. In 1999, the DEA downgraded Marinol from a schedule II to a schedule III controlled substance.
Under the proposed change, both the marijuana plant and plant-derived THC that is not contained in a FDA-approved pharmaceutical drug would remain classified as schedule I illicit substances.
"THC, natural or synthetic, remains a schedule I controlled substance," DEA spokesman Rusty Payne told The Daily Caller in an e-mail. "Under the proposed rule, in those instances in the future where FDA might approve a generic version of Marinol, that version of the drug will be in the same schedule as the brand name version of the drug, regardless of whether the THC used in the generic version was synthesized by man or derived from the cannabis plant."
Without changes in federal policy, pharmaceutical manufacturers wishing to develop products containing plant-derived THC would need to acquire it from the University of Mississippi at Oxford, the only federally-licensed marijuana production facility in America.
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