Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

Results 1 - 50 of 2,991
Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc.
Document Number: 2018-03723
Type: Notice
Date: 2018-02-23
Agency: Drug Enforcement Administration, Department of Justice
Robert C. Vidaver, M.D.; Decision and Order
Document Number: 2018-03303
Type: Notice
Date: 2018-02-20
Agency: Drug Enforcement Administration, Department of Justice
James E. Ranochak, M.D.; Decision and Order
Document Number: 2018-03301
Type: Notice
Date: 2018-02-20
Agency: Drug Enforcement Administration, Department of Justice
Kenneth N. Woliner, M.D.; Decision and Order
Document Number: 2018-03299
Type: Notice
Date: 2018-02-20
Agency: Drug Enforcement Administration, Department of Justice
Taylor Animal Shelter; Order
Document Number: 2018-03298
Type: Notice
Date: 2018-02-20
Agency: Drug Enforcement Administration, Department of Justice
Trinity Pharmacy I; Order Terminating Registration
Document Number: 2018-03297
Type: Notice
Date: 2018-02-20
Agency: Drug Enforcement Administration, Department of Justice
Trinity Pharmacy II; Decision and Order
Document Number: 2018-03294
Type: Notice
Date: 2018-02-20
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc.
Document Number: 2018-03293
Type: Notice
Date: 2018-02-20
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Meridian Medical Technologies Inc.
Document Number: 2018-02647
Type: Notice
Date: 2018-02-09
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Noramco, Inc.
Document Number: 2018-02646
Type: Notice
Date: 2018-02-09
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.
Document Number: 2018-02645
Type: Notice
Date: 2018-02-09
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc.
Document Number: 2018-02644
Type: Notice
Date: 2018-02-09
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: INSYS Manufacturing LLC
Document Number: 2018-02643
Type: Notice
Date: 2018-02-09
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics Inc.
Document Number: 2018-02642
Type: Notice
Date: 2018-02-09
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mylan Technologies Inc.
Document Number: 2018-02641
Type: Notice
Date: 2018-02-09
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Johnson Matthey Inc.
Document Number: 2018-02639
Type: Notice
Date: 2018-02-09
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2018-02638
Type: Notice
Date: 2018-02-09
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc.
Document Number: 2018-02637
Type: Notice
Date: 2018-02-09
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc.
Document Number: 2018-02345
Type: Notice
Date: 2018-02-06
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc.
Document Number: 2018-02343
Type: Notice
Date: 2018-02-06
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals
Document Number: 2018-02341
Type: Notice
Date: 2018-02-06
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I
Document Number: 2018-02319
Type: Rule
Date: 2018-02-06
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule fentanyl-related substances that are not currently listed in any schedule of the Controlled Substances Act (CSA) and their 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 these synthetic opioids in schedule I 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 fentanyl-related substances.
Schedules of Controlled Substances: Temporary Placement of Seven Fentanyl-Related Substances in Schedule I
Document Number: 2018-02008
Type: Rule
Date: 2018-02-01
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule seven fentanyl- related substances in schedule I. These seven substances are: N-(1- phenethylpiperidin-4-yl)-N-phenylpentanamide (valeryl fentanyl), N-(4- fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide (para- fluorobutyryl fentanyl), N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4- yl)butyramide (para-methoxybutyryl fentanyl), N-(4-chlorophenyl)-N-(1- phenethylpiperidin-4-yl)isobutyramide (para-chloroisobutyryl fentanyl), N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide (isobutyryl fentanyl), N-(1-phenethylpiperidin-4-yl)-N- phenylcyclopentanecarboxamide (cyclopentyl fentanyl), and N-(2- fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4-yl)acetamid e (ocfentanil). This action is based on a finding by the Administrator that the placement of these seven synthetic opioids 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, valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil.
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2018-02007
Type: Notice
Date: 2018-02-01
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: 2018-02006
Type: Notice
Date: 2018-02-01
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 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
Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals LLC
Document Number: 2017-28178
Type: Notice
Date: 2017-12-29
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cambrex High Point, Inc.
Document Number: 2017-28177
Type: Notice
Date: 2017-12-29
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: ABBVIE LTD; Correction
Document Number: 2017-28176
Type: Notice
Date: 2017-12-29
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) published a document in the Federal Register of December 1, 2017, concerning a notice of application that inadvertently misstated what the firm plans to do with imported tapentadol.
Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I
Document Number: 2017-28114
Type: Proposed Rule
Date: 2017-12-29
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is publishing this notice of intent to issue an order temporarily scheduling fentanyl-related substances that are not currently listed in any schedule of the Controlled Substances Act (CSA). The temporary order will place these substances in schedule I. This action is based on a finding by the Administrator that the placement of these synthetic opioids in schedule I is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose regulatory requirements under the CSA on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of these synthetic opioids, as well as administrative, civil, and criminal remedies with respect to persons who fail to comply with such requirements or otherwise violate the CSA with respect to these substances.
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2017-27512
Type: Notice
Date: 2017-12-21
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.
Michel P. Toret, M.D.; Decision and Order
Document Number: 2017-27186
Type: Notice
Date: 2017-12-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: VHG Labs DBA LGC Standard Warehouse
Document Number: 2017-26855
Type: Notice
Date: 2017-12-13
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of Seven Fentanyl-Related Substances in Schedule I
Document Number: 2017-26854
Type: Proposed Rule
Date: 2017-12-13
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 seven fentanyl-related substances in schedule I. These seven substances are: N-(1-phenethylpiperidin-4-yl)- N-phenylpentanamide (valeryl fentanyl), N-(4-fluorophenyl)- N-(1-phenethylpiperidin- 4-yl)butyramide (para-fluorobutyryl fentanyl), N-(4-methoxyphenyl)- N-(1- phenethylpiperidin-4-yl)butyramide (para-methoxybutyryl fentanyl), N- (4-chlorophenyl)- N-(1-phenethylpiperidin-4-yl)isobutyramide (para- chloroisobutyryl fentanyl), N-(1-phenethylpiperidin- 4-yl)-N- phenylisobutyramide (isobutyryl fentanyl), N-(1-phenethylpiperidin-4- yl)- N-phenylcyclopentane carboxamide (cyclopentyl fentanyl), and N-(2- fluorophenyl)- 2-methoxy-N-(1-phenethylpiperidin- 4-yl)acetamide (ocfentanil). This action is based on a finding by the Administrator that the placement of these seven synthetic opioids in schedule I of the Controlled Substances Act (CSA) 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 CSA 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: Placement of MT-45 Into Schedule I
Document Number: 2017-26853
Type: Rule
Date: 2017-12-13
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final order, the Administrator of the Drug Enforcement Administration places the substance MT-45 (Systematic IUPAC Name: 1-cyclohexyl-4-(1,2-diphenylethyl)piperazine), including its salts, isomers, and salts of isomers into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act and is required in order for the United States to discharge its obligations under the Single Convention on Narcotic Drugs, 1961. This action imposes 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 or conduct instructional activities with, or possess), or propose to handle, MT-45.
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