Schedules of Controlled Substances: Placement of Tapentadol Into Schedule II

This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance tapentadol, including its isomers, esters, ethers, salts and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible, into schedule II of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Assistant Secretary for Health of the Department of Health and Human Services (DHHS) and on an evaluation of the relevant data by DEA. If finalized, this action would impose the regulatory controls and criminal sanctions of schedule II on those who handle tapentadol and products containing tapentadol.