Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

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Schedules of Controlled Substances: Placement of AB-CHMINACA, AB-PINACA and THJ-2201 Into Schedule I
Document Number: 2017-22325
Type: Rule
Date: 2017-10-16
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Drug Enforcement Administration places N-(1-amino-3-methyl-1-oxobutan-2-yl)-1- (cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA), N-(1-amino- 3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB- PINACA), and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1- yl)methanone (THJ-2201), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This rule continues the imposition of 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 AB-CHMINACA, AB- PINACA and THJ-2201.
Warren B. Dailey, M.D.; Decision and Order
Document Number: 2017-21382
Type: Notice
Date: 2017-10-05
Agency: Drug Enforcement Administration, Department of Justice
William J. O'Brien, III, D.O.; Decision and Order
Document Number: 2017-21380
Type: Notice
Date: 2017-10-05
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute
Document Number: 2017-20947
Type: Notice
Date: 2017-09-29
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2017-20943
Type: Notice
Date: 2017-09-29
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: Cody Laboratories, Inc.
Document Number: 2017-20942
Type: Notice
Date: 2017-09-29
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Bellwyck Clinical Services
Document Number: 2017-20941
Type: Notice
Date: 2017-09-29
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Removal of Naldemedine From Control
Document Number: 2017-20919
Type: Rule
Date: 2017-09-29
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Drug Enforcement Administration removes the substance naldemedine (4R,4aS,7aR,12bS)-3- (cyclopropylmethyl)-4a,7,9-trihydroxy-N-(2-(3-phenyl-1,2,4-ox adiazol-5- yl)propan-2-yl)-2,3,4,4a,5,7a-hexahydro-1H-4,12-methanobenzof uro[3,2- e]isoquinoline-6-carboxamide) including its salts from the schedules of the Controlled Substances Act. Prior to the effective date of this rule, naldemedine was a schedule II controlled substance because it can be derived from opium alkaloids. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle naldemedine.
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2017-20479
Type: Notice
Date: 2017-09-26
Agency: Drug Enforcement Administration, Department of Justice
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration as bulk manufacturers of various classes of controlled substances.
Importer of Controlled Substances Application: Sharp Clinical Services, Inc.
Document Number: 2017-19836
Type: Notice
Date: 2017-09-18
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, Inc.
Document Number: 2017-19834
Type: Notice
Date: 2017-09-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Catalent Centers, LLC
Document Number: 2017-19833
Type: Notice
Date: 2017-09-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc.
Document Number: 2017-19832
Type: Notice
Date: 2017-09-18
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals LLC
Document Number: 2017-19831
Type: Notice
Date: 2017-09-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Unither Manufacturing LLC
Document Number: 2017-19830
Type: Notice
Date: 2017-09-18
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Specgx LLC
Document Number: 2017-19786
Type: Notice
Date: 2017-09-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Specgx LLC
Document Number: 2017-19784
Type: Notice
Date: 2017-09-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2017-19067
Type: Notice
Date: 2017-09-15
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of Ortho-Fluorofentanyl, Tetrahydrofuranyl Fentanyl, and Methoxyacetyl Fentanyl Into Schedule I
Document Number: 2017-19283
Type: Proposed Rule
Date: 2017-09-12
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule the synthetic opioids, N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4- yl)propionamide (ortho-fluorofentanyl or 2-fluorofentanyl), N-(1- phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamid e (tetrahydrofuranyl fentanyl), and 2-methoxy-N-(1-phenethylpiperidin-4- yl)-N-phenylacetamide (methoxyacetyl fentanyl), into Schedule I. This action is based on a finding by the Administrator that the placement of these synthetic opioids into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to Schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of these synthetic opioids.
Schedules of Controlled Substances: Temporary Placement of FUB-AMB Into Schedule I
Document Number: 2017-17639
Type: Proposed Rule
Date: 2017-09-11
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule the synthetic cannabinoid, Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3- carboxamido)-3-methylbutanoate [FUB-AMB, MMB-FUBINACA, AMB-FUBINACA], into Schedule I. This action is based on a finding by the Administrator that the placement of this synthetic cannabinoid into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to Schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, possession, importation, exportation of, and research and conduct with, instructional activities of this synthetic cannabinoid.
Importer of Controlled Substances Application: Akorn, Inc.
Document Number: 2017-18803
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Siegfried USA, LLC
Document Number: 2017-18802
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc.
Document Number: 2017-18801
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Stepan Company
Document Number: 2017-18789
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Spex Certiprep Group, LLC
Document Number: 2017-18788
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: KVK-Tech, Inc.
Document Number: 2017-18787
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2017-18785
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Marcus W. Anderson, M.D.; Decision and Order
Document Number: 2017-18784
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cody Laboratories, Inc.
Document Number: 2017-18316
Type: Notice
Date: 2017-08-29
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.
Document Number: 2017-18315
Type: Notice
Date: 2017-08-29
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cambrex Charles City
Document Number: 2017-18314
Type: Notice
Date: 2017-08-29
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Stepan Company
Document Number: 2017-18313
Type: Notice
Date: 2017-08-29
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Fresenius Kabi USA, LLC
Document Number: 2017-18312
Type: Notice
Date: 2017-08-29
Agency: Drug Enforcement Administration, Department of Justice
Binh M. Chung, M.D.; Decision and Order
Document Number: 2017-18081
Type: Notice
Date: 2017-08-25
Agency: Drug Enforcement Administration, Department of Justice
Arnold E. Feldman, M.D.; Decision and Order
Document Number: 2017-17640
Type: Notice
Date: 2017-08-21
Agency: Drug Enforcement Administration, Department of Justice
Masters Pharmaceutical, Inc.; Order
Document Number: 2017-17638
Type: Notice
Date: 2017-08-21
Agency: Drug Enforcement Administration, Department of Justice
Raman I. Popli, M.D.; Decision and Order
Document Number: 2017-17146
Type: Notice
Date: 2017-08-15
Agency: Drug Enforcement Administration, Department of Justice
Luis C B Gomez, D.D.S. Decision and Order
Document Number: 2017-17011
Type: Notice
Date: 2017-08-11
Agency: Drug Enforcement Administration, Department of Justice
Leia A. Frickey, M.D.; Decision and Order
Document Number: 2017-16700
Type: Notice
Date: 2017-08-08
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI)
Document Number: 2017-16699
Type: Notice
Date: 2017-08-08
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2017-16698
Type: Notice
Date: 2017-08-08
Agency: Drug Enforcement Administration, Department of Justice
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of various classes of schedule I or II controlled substances.
Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2018
Document Number: 2017-16439
Type: Notice
Date: 2017-08-07
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes to establish the 2018 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
John D. Bray-Morris, M.D.; Decision and Order
Document Number: 2017-16446
Type: Notice
Date: 2017-08-04
Agency: Drug Enforcement Administration, Department of Justice
Marcia L. Sills, M.D.; Decision and Order
Document Number: 2017-16442
Type: Notice
Date: 2017-08-04
Agency: Drug Enforcement Administration, Department of Justice
Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2017
Document Number: 2017-16440
Type: Notice
Date: 2017-08-04
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes to adjust the 2017 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Importer of Controlled Substances Application: Cambrex High Point, Inc.
Document Number: 2017-16058
Type: Notice
Date: 2017-08-02
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: R & D Systems, Inc.
Document Number: 2017-16064
Type: Notice
Date: 2017-07-31
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Isosciences, LLC
Document Number: 2017-16060
Type: Notice
Date: 2017-07-31
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Sigma-Aldrich International GMBH
Document Number: 2017-16059
Type: Notice
Date: 2017-07-31
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: United States Pharmacopeial Convention
Document Number: 2017-15693
Type: Notice
Date: 2017-07-26
Agency: Drug Enforcement Administration, Department of Justice