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.
Designation of Oripavine as a Basic Class of Controlled Substance
This is a final rule issued by the Drug Enforcement Administration (DEA) designating oripavine (3-O-demethylthebaine or 6,7,8,14-tetradehydro-4,5-alpha-epoxy-6-methoxy-17-methylmorp hinan-3- ol) as a basic class in schedule II of the Controlled Substances Act (CSA). Although oripavine was not previously listed in schedule II of the CSA, it has been controlled in the United States as a derivative of thebaine and, as such, is controlled as a schedule II controlled substance which includes ``Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate.'' Oripavine is a derivative of thebaine, a natural constituent of opium, hence oripavine has been and continues to be, by virtue of the definition of ``narcotic drug'', a schedule II controlled substance. International control of oripavine in schedule I of the 1961 Single Convention on Narcotic Drugs (1961 Convention) during the 50th session of the Commission on Narcotic Drugs (CND) in 2007 prompted the DEA to specifically designate oripavine as a basic class of controlled substance in schedule II of the CSA.