Technical Amendment to Listing in Schedule III of Approved Drug Products Containing Tetrahydrocannabinols

Under the current schedules of controlled substances in the DEA regulations, among the substances listed in schedule III is a synthetic isomer of tetrahydrocannabinols (THC) contained in a specific formulation of a drug product approved by the U.S. Food and Drug Administration (FDA). As currently written, the DEA regulation would not necessarily include drug products approved by the FDA under section 505(j) of the Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 355) (commonly referred to as generic drugs) that cite the drug product currently listed in schedule III as the reference listed drug. DEA is hereby proposing to modify the regulation so that certain generic drug products are also included in the schedule III listing.