Drug Enforcement Administration May 2021 – Federal Register Recent Federal Regulation Documents

Purisys, 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.

American Radiolabeled Chem 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.

This final rule adopts an interim final rule with request for comments published in the Federal Register on January 31, 2020, placing lasmiditan (2,4,6-trifluoro-N-(6-(1-methylpiperidine-4- carbonyl)pyridine-2-yl-benzamide), including its salts, in schedule V of the Controlled Substances Act without change, apart from a minor amendment to the placement ordering of lasmiditan already made by intervening rules. With the issuance of this final rule, the Drug Enforcement Administration maintains lasmiditan, including its salts, in schedule V of the Controlled Substances Act.

SPECGX 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.

Unither Manufacturing 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.

On March 2, 2021, the United States Food and Drug Administration approved a new drug application for AZSTARYS capsules for oral use, a combination drug product containing serdexmethylphenidate chloride and dexmethylphenidate hydrochloride, for the treatment of Attention Deficit Hyperactivity Disorder in patients six years of age or older. The Department of Health and Human Services provided the Drug Enforcement Administration with a scheduling recommendation to place serdexmethylphenidate and its salts in schedule IV of the Controlled Substances Act. In accordance with the Controlled Substances Act, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, Drug Enforcement Administration is hereby issuing an interim final rule placing serdexmethylphenidate, including its salts, isomers, and salts of isomers, in schedule IV of the Controlled Substances Act, thereby facilitating the commercial distribution of AZSTARYS as a lawful controlled substance.

The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.

The Drug Enforcement Administration places four specified fentanyl-related substances permanently in schedule I of the Controlled Substances Act. These four specific substances fall within the definition of fentanyl-related substances set forth in the February 6, 2018, temporary scheduling order. Through the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act, which became law on February 6, 2020, Congress extended the temporary control of fentanyl-related substances until May 6, 2021. The regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle any of these four specified fentanyl-related substances will continue to be applicable permanently as a result of this action.

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