Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

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Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceutical, Inc.
Document Number: 2017-26507
Type: Notice
Date: 2017-12-08
Agency: Drug Enforcement Administration, Department of Justice
Kofi E. Shaw-Taylor, M.D. Decision and Order
Document Number: 2017-25922
Type: Notice
Date: 2017-12-01
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: ABBVIE LTD
Document Number: 2017-25921
Type: Notice
Date: 2017-12-01
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Nanosyn, Inc.
Document Number: 2017-25916
Type: Notice
Date: 2017-12-01
Agency: Drug Enforcement Administration, Department of Justice
First Choice Surgery Center of Baton Rouge, L.L.C.; Decision and Order
Document Number: 2017-25288
Type: Notice
Date: 2017-11-22
Agency: Drug Enforcement Administration, Department of Justice
Arnold E. Feldman, M.D.; Decision and Order
Document Number: 2017-25287
Type: Notice
Date: 2017-11-22
Agency: Drug Enforcement Administration, Department of Justice
Linda M. Shuck, D.O.; Decision and Order
Document Number: 2017-25286
Type: Notice
Date: 2017-11-22
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2017-25285
Type: Notice
Date: 2017-11-22
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 schedule I and II controlled substances.
Importer of Controlled Substances Registration
Document Number: 2017-25284
Type: Notice
Date: 2017-11-22
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.
Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] in Schedule II
Document Number: 2017-25275
Type: Rule
Date: 2017-11-22
Agency: Drug Enforcement Administration, Department of Justice
This final rule adopts without changes an interim final rule with request for comments published in the Federal Register on March 23, 2017. On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] oral solution. The Drug Enforcement Administration (DEA) maintains FDA- approved products of oral solutions containing dronabinol in schedule II of the Controlled Substances Act.
Schedules of Controlled Substances: Temporary Placement of Cyclopropyl Fentanyl into Schedule I
Document Number: 2017-25077
Type: Proposed Rule
Date: 2017-11-21
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 opioid, N-(1-phenethylpiperidin-4-yl)-N- phenylcyclopropanecarboxamide (cyclopropyl fentanyl), into Schedule I. This action is based on a finding by the Administrator that the placement of this synthetic opioid 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 this synthetic opioid.
Importer of Controlled Substances Application: Anderson Brecon, Inc.
Document Number: 2017-24674
Type: Notice
Date: 2017-11-15
Agency: Drug Enforcement Administration, Department of Justice
Established 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: 2017-24306
Type: Notice
Date: 2017-11-08
Agency: Drug Enforcement Administration, Department of Justice
This final order establishes the initial 2018 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City
Document Number: 2017-24201
Type: Notice
Date: 2017-11-07
Agency: Drug Enforcement Administration, Department of Justice
ChipRX, L.L.C., d/b/a City Center Pharmacy; Decision and Order
Document Number: 2017-24093
Type: Notice
Date: 2017-11-06
Agency: Drug Enforcement Administration, Department of Justice
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Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2017-24090
Type: Notice
Date: 2017-11-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Rhodes Technologies
Document Number: 2017-24012
Type: Notice
Date: 2017-11-03
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of FUB-AMB Into Schedule I
Document Number: 2017-24010
Type: Rule
Date: 2017-11-03
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic cannabinoid, methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3- methylbutanoate [FUB-AMB, MMB-FUBINACA, AMB-FUBINACA], and its optical, positional, and geometric isomers, salts, and salts of isomers 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. 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, FUB-AMB.
Final Adjusted 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: 2017-24009
Type: Notice
Date: 2017-11-03
Agency: Drug Enforcement Administration, Department of Justice
This final order establishes the final adjusted 2017 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Bulk Manufacturer of Controlled Substances Application: Euticals Inc.
Document Number: 2017-23556
Type: Notice
Date: 2017-10-30
Agency: Drug Enforcement Administration, Department of Justice
Lon F. Alexander, M.D.; Decision and Order
Document Number: 2017-23339
Type: Notice
Date: 2017-10-26
Agency: Drug Enforcement Administration, Department of Justice
Harinder Takyar, M.D.; Decision and Order
Document Number: 2017-23338
Type: Notice
Date: 2017-10-26
Agency: Drug Enforcement Administration, Department of Justice
Yoon H. Choi, M.D.; Decision and Order
Document Number: 2017-23329
Type: Notice
Date: 2017-10-26
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Galephar Pharmaceutical Research, Inc.
Document Number: 2017-23328
Type: Notice
Date: 2017-10-26
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: 2017-23206
Type: Rule
Date: 2017-10-26
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling 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-carboxamide (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 ortho- fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl into 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, ortho- fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl.
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