Drug Enforcement Administration January 2018 – Federal Register Recent Federal Regulation Documents

Schedules of Controlled Substances: Placement of MAB-CHMINACA Into Schedule I
Document Number: 2018-01747
Type: Proposed Rule
Date: 2018-01-30
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing N-(1- amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-i ndazole-3- carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle MAB-CHMINACA.
Schedules of Controlled Substances: Extension of Temporary Placement of MAB-CHMINACA in Schedule I of the Controlled Substances Act
Document Number: 2018-01746
Type: Rule
Date: 2018-01-30
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of a synthetic cannabinoid, N-(1-amino-3,3-dimethyl- 1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxami de (other names: MAB-CHMINACA; ADB-CHMINACA), including its optical, positional and geometric isomers, salts, and salts of isomers. The schedule I status of MAB-CHMINACA currently is in effect through February 4, 2018. This temporary order will extend the temporary scheduling of MAB- CHMINACA for one year, or until the permanent scheduling action for this substance is completed, whichever occurs first.
Bulk Manufacturer of Controlled Substances Application: Organix, Inc.
Document Number: C1-2017-28180
Type: Notice
Date: 2018-01-23
Agency: Drug Enforcement Administration, Department of Justice
Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs for Opioid Use Disorder
Document Number: 2018-01173
Type: Rule
Date: 2018-01-23
Agency: Drug Enforcement Administration, Department of Justice
The Comprehensive Addiction and Recovery Act (CARA) of 2016, which became law on July 22, 2016, amended the Controlled Substances Act (CSA) to expand the categories of practitioners who may, under certain conditions on a temporary basis, dispense a narcotic drug in Schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. Separately, the Department of Health and Human Services, by final rule effective August 8, 2016, increased to 275 the maximum number of patients that a practitioner may treat for opioid use disorder without being separately registered under the CSA for that purpose. The Drug Enforcement Administration (DEA) is hereby amending its regulations to incorporate these statutory and regulatory changes.
Bulk Manufacturer of Controlled Substances Application: Chemtos, LLC
Document Number: 2018-00710
Type: Notice
Date: 2018-01-18
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Alcami Wisconsin Corporation
Document Number: 2018-00709
Type: Notice
Date: 2018-01-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Janssen Pharmaceuticals, Inc.
Document Number: 2018-00508
Type: Notice
Date: 2018-01-16
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC
Document Number: 2018-00507
Type: Notice
Date: 2018-01-16
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc.
Document Number: 2018-00506
Type: Notice
Date: 2018-01-16
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2018-00118
Type: Notice
Date: 2018-01-08
Agency: Drug Enforcement Administration, Department of Justice
Registrants listed below have applied for and been granted registration by-the Drug Enforcement Administration as importers of various classes of schedule I or II controlled substances.
Importer of Controlled Substances Application: Sharp (Bethlehem), LLC
Document Number: 2017-28471
Type: Notice
Date: 2018-01-04
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of Cyclopropyl Fentanyl in Schedule I
Document Number: 2017-28470
Type: Rule
Date: 2018-01-04
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide (cyclopropyl fentanyl), and its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers in schedule I. This action is based on a finding by the Administrator that the placement of cyclopropyl fentanyl in schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed 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, cyclopropyl fentanyl.
Bulk Manufacturer of Controlled Substances Application: Organix, Inc.
Document Number: 2017-28180
Type: Notice
Date: 2018-01-04
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Organix, Inc.
Document Number: 2017-28269
Type: Notice
Date: 2018-01-02
Agency: Drug Enforcement Administration, Department of Justice
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