Drug Enforcement Administration September 2022 – Federal Register Recent Federal Regulation Documents

This final rule adopts without change an interim final rule with request for comments published in the Federal Register on April 7, 2022, placing daridorexant ([(S)-2-(5-chloro-4-methyl-1H- benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl](5-methoxy-2-( 2H-1,2,3- triazol-2-yl)phenyl)methanone), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of such isomers is possible, in schedule IV of the Controlled Substances Act (CSA). With the issuance of this final rule, the Drug Enforcement Administration maintains daridorexant in schedule IV of the CSA.

The Drug Enforcement Administration is proposing the control of 4-piperidone, its acetals, its amides, its carbamates, its salts, and salts of its acetals, its amides, and its carbamates, whenever the existence of such is possible, as a list I chemical under the Controlled Substances Act. The Drug Enforcement Administration finds that 4-piperidone is used in the illicit manufacture of the controlled substance fentanyl, and is important to the manufacture of the controlled substance fentanyl because it cannot be replaced by other chemicals in its respective synthetic pathways which are used in the illicit manufacture of fentanyl. If finalized, this action would subject handlers of 4-piperidone to the chemical regulatory provisions of the Controlled Substances Act and its implementing regulations. This rulemaking does not establish a threshold for domestic and international transactions of 4-piperidone. As such, all transactions of chemical mixtures containing 4-piperidone will be regulated at any concentration and will be subject to control under the Controlled Substances Act.

Curia Wisconsin, Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

Wedgewood Village Pharmacy, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.