Schedules of Controlled Substances: Placement of Remifentanil Into Schedule II

With the issuance of this final rule, the Acting Deputy Administrator of the Drug Enforcement Administration (DEA) places the narcotic drug, remifentanil and salts thereof, into Schedule II of the Controlled Substances Act (CSA) (21 U.S.C. 801 et seq.). This rule imposes the regulatory controls and criminal sanctions of a Schedule II narcotic substance under the CSA on the manufacture, distribution, dispensing, importation, and exportation of remifentanil and salts thereof. Remifentanil hydrochloride was recently approved by the Food and Drug Administration (FDA) for marketing as an intravenous analgesic agent.