Schedules of Controlled Substances: Addition of Gamma-Hydroxybutyric Acid to Schedule I

This is a final rule issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) placing gamma-hydroxybutyric acid (GHB) and its salts, isomers, and salts of isomers into Schedule I of the Controlled Substances Act (CSA) pursuant to Public Law 106-172. Public Law 106-172 also imposes Schedule III physical security requirements for storage on registered manufacturers and distributors of GHB when it is manufactured, distributed or possessed in accordance with Food and Drug Administration (FDA)-authorized Investigational New Drug (IND) exemptions under the Federal Food, Drug and Cosmetic Act (FFDCA). In addition, this final rule places FDA-approved products containing GHB into Schedule III, if or when they are approved.