Listing of Approved Drug Products Containing Dronabinol in Schedule III

This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to modify the listing of the Marinol[supreg] formulation in schedule III so that certain generic drug products are also included in that listing. Several products are currently the subject of Abbreviated New Drug Applications (ANDAs) under review by the U.S. Food and Drug Administration (FDA). Each product is a generic formulation of Marinol[supreg] and contains dronabinol, the (-) isomer of delta-9- (trans)-tetrahydrocannabinol (THC), which is a schedule I controlled substance. Due to variations in formulation, these generic Marinol[supreg] products do not meet the specific conditions specified in the current schedule III listing. This proposed action expands the schedule III listing to include formulations having naturally-derived dronabinol and products encapsulated in hard gelatin capsules. This would have the effect of transferring the FDA-approved versions of such generic Marinol[supreg] products from schedule I to schedule III.