Schedules of Controlled Substances: Proposed Placement of Modafinil Into Schedule IV

This proposed rule is issued by the Acting Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance modafinil, including its salts, isomers and salts of isomers, into Schedule IV of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Acting Assistant Secretary for Health of the Department of Health and Human Services (DHHS) that modafinil be added to Schedule IV and on an evaluation of the relevant data by the DEA. The scheduling of modafinil in Schedule IV will not be finalized until the New Drug Application (NDA) for modafinil is approved by the Food and Drug Administration (FDA). If finalized, this action will impose the regulatory controls and criminal sanctions of Schedule IV on those who handle modafinil and products containing modafinil.