Schedules of Controlled Substances: Rescheduling of Synthetic Dronabinol (MartinolSUP/SUP; (-)-greek-DSUP9/SUP-(trans)- Tetrahydrocannabinol in Sesame oil and Encapsulated in Soft Gelatin Capsules) From Schedule II to Schedule III.

This proposed rule is issued by the Acting Deputy Administrator of the Drug Enforcement Administration (DEA) to remove the Food and Drug Administration (FDA) approved drug product containing dronabinol [Marinol<SUP></SUP>; (-)-<INF>x-6<SUP>9</SUP></INF>- (trans)-tetrahydrocannabinol in sesame oil and encapsulated in soft gelatin capsules] from Schedule II and place it into Schedule III of the Controlled Substances Act (CSA). This proposed action is based on an evaluation of the relevant data by the DEA and a recommendation from the Assistant Secretary for Health of the Department of Health and Human Services (DHHS) that the FDA-approved dronabinol product [Marinol<SUP></SUP>; (-)- <greek-D><SUP>9</SUP>-(trans)-THC in sesame oil and encapsulated in soft gelatin capsules] be rescheduled from Schedule II to Schedule III. If finalized, this action will impose the regulatory controls and criminal sanctions of Schedule III on those who handle dronabinol and products containing dronabinol.