Drug Enforcement Administration August 2024 – 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 October 31, 2023, placing zuranolone (chemically known as 1-[2- [(3R,5R,8R,9R,10S,13S,14S,17S)-3-hydroxy-3,13-dimethyl- 2,4,5,6,7,8,9,10,11,12,14,15,16,17-tetradecahydro-1H- cyclopenta[a]phenanthren-17-yl]-2-oxoethyl]pyrazole-4-carboni trile) and its salts in schedule IV of the Controlled Substances Act. With the issuance of this final rule, the Drug Enforcement Administration maintains zuranolone, including its salts, in schedule IV of the Controlled Substances Act.

Benuvia Operations, 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.

Catalent Greenville, Inc., 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.

AMPAC Fine Chemicals, LLC 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.

Cambrex High Point, Inc., 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.