Schedules of Controlled Substances: Placement of Lisdexamfetamine into Schedule II

This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance lisdexamfetamine, including its salts, isomers, and salts of isomers, 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. This scheduling of lisdexamfetamine in schedule II will not be finalized until a New Drug Application (NDA) for a lisdexamfetamine product is approved by the Food and Drug Administration (FDA). If finalized, this action would impose the regulatory controls and criminal sanctions of schedule II on those who handle lisdexamfetamine and products containing lisdexamfetamine.