Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 3,540
Theresa L. Wendt, N.P.; Decision and Order
Document Number: 2020-01970
Type: Notice
Date: 2020-02-03
Agency: Drug Enforcement Administration, Department of Justice
Kambiz Haghighi, M.D.; Decision and Order
Document Number: 2020-01969
Type: Notice
Date: 2020-02-03
Agency: Drug Enforcement Administration, Department of Justice
Andrzej Kazimierz Zielke, M.D.; Decision and Order
Document Number: 2020-01968
Type: Notice
Date: 2020-02-03
Agency: Drug Enforcement Administration, Department of Justice
Shelton W. Barnes, M.D.; Decision and Order
Document Number: 2020-01967
Type: Notice
Date: 2020-02-03
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturers of Marihuana: Spocannabis LLC
Document Number: 2020-01966
Type: Notice
Date: 2020-02-03
Agency: Drug Enforcement Administration, Department of Justice
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 classes of controlled substances listed in schedule I. Prior to making decisions on this and other pending applications, DEA intends to promulgate regulations that govern the program of growing marihuana for scientific and medical research under DEA registration.
Bulk Manufacturer of Controlled Substances Application: IsoSciences, LLC
Document Number: 2020-01960
Type: Notice
Date: 2020-02-03
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Noramco Inc.
Document Number: 2020-01959
Type: Notice
Date: 2020-02-03
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Stepan Company
Document Number: 2020-01958
Type: Notice
Date: 2020-02-03
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Lasmiditan in Schedule V
Document Number: 2020-01957
Type: Rule
Date: 2020-01-31
Agency: Drug Enforcement Administration, Department of Justice
On October 11, 2019, the U.S. Food and Drug Administration approved a new drug application for Reyvow (lasmiditan) tablets for oral use. Lasmiditan is chemically known as [2,4,6-trifluoro-N-(6-(1- methylpiperidine-4-carbonyl)pyridine-2-yl-benzamide]. Thereafter, the Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place lasmiditan in schedule V of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing lasmiditan, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule V of the CSA.
Schedules of Controlled Substances: Extension of Temporary Placement of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl in Schedule I of the Controlled Substances Act
Document Number: 2020-01683
Type: Rule
Date: 2020-01-30
Agency: Drug Enforcement Administration, Department of Justice
The Acting Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of cyclopentyl fentanyl (N-(1- phenethylpiperidin-4-yl)-N-phenylcyclopentanecarboxamide), isobutyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide), para- chloroisobutyryl fentanyl (N-(4-chlorophenyl)-N-(1-phenethylpiperidin- 4-yl)isobutyramide), para-methoxybutyryl fentanyl (N-(4-methoxyphenyl)- N-(1-phenethylpiperidin-4-yl)butyramide), and valeryl fentanyl (N-(1- phenethylpiperidin-4-yl)-N-phenylpentanamide) including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers. The schedule I status of cyclopentyl fentanyl, isobutyryl fentanyl, para- chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl currently is in effect until February 1, 2020. This temporary order will extend the temporary scheduling of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para- methoxybutyryl fentanyl, and valeryl fentanyl for one year, or until the permanent scheduling action for these substances is completed, whichever occurs first.
Schedules of Controlled Substances: Placement of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl Into Schedule I
Document Number: 2020-01681
Type: Proposed Rule
Date: 2020-01-30
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing cyclopentyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- phenylcyclopentanecarboxamide), isobutyryl fentanyl (N-(1- phenethylpiperidin-4-yl)-N-phenylisobutyramide), para-chloroisobutyryl fentanyl (N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4- yl)isobutyramide), para-methoxybutyryl fentanyl (N-(4-methoxyphenyl)-N- (1-phenethylpiperidin-4-yl)butyramide), and valeryl fentanyl (N-(1- phenethylpiperidin-4-yl)-N-phenylpentanamide), including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers whenever the existence of such isomers, esters, ethers and salts is possible, in schedule I of the Controlled Substances Act. If finalized, this action would make permanent the existing 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 cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para- methoxybutyryl fentanyl, and valeryl fentanyl.
Additions to Listing of Exempt Chemical Mixtures
Document Number: 2020-00667
Type: Rule
Date: 2020-01-27
Agency: Drug Enforcement Administration, Department of Justice
Under this direct final rule, the Drug Enforcement Administration (DEA) is updating the Table of Exempt Chemical Mixtures to include the listing of 15 additional preparations. This action is in response to DEA's review of new applications for exemption. Having reviewed applications and relevant information, DEA finds that these preparations meet the applicable exemption criteria. Therefore, these products are exempted from the application of certain provisions of the Controlled Substances Act.
Schedules of Controlled Substances: Placement of Brexanolone in Schedule IV
Document Number: 2020-00669
Type: Rule
Date: 2020-01-24
Agency: Drug Enforcement Administration, Department of Justice
This final rule adopts without change an interim final rule with request for comments published in the Federal Register on June 17, 2019. That interim final rule placed the substance brexanolone (3[alpha]-hydroxy-5[alpha]-pregnan-20-one), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the Controlled Substances Act. With the issuance of this final rule, the Drug Enforcement Administration maintains brexanolone in schedule IV of the Controlled Substances Act.
Schedules of Controlled Substances: Placement of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA in Schedule I
Document Number: 2020-00665
Type: Rule
Date: 2020-01-24
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration places methyl 2-(1-(5- fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoat e [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole-3- carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5- fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1- amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-ind azole-3- carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1H-indole-3- carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA]; and methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3- dimethylbutanoate [MDMB-FUBINACA], including their 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. This action 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 5F- ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA.
Schedules of Controlled Substances: Removal of 6β-Naltrexol From Control
Document Number: 2020-00664
Type: Rule
Date: 2020-01-24
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Acting Administrator of the Drug Enforcement Administration removes (5[alpha],6[beta])-17- (cyclopropylmethyl)-4,5-epoxymorphinan-3,6,14-triol (6[beta]-naltrexol) and its salts from the schedules of the Controlled Substances Act (CSA). This scheduling action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. Prior to the effective date of this rule, 6[beta]-naltrexol 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 6[beta]-naltrexol.
Importer of Controlled Substances Application: S&B Pharma, Inc.
Document Number: 2020-00661
Type: Notice
Date: 2020-01-17
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Solriamfetol in Schedule IV
Document Number: 2019-27955
Type: Rule
Date: 2020-01-07
Agency: Drug Enforcement Administration, Department of Justice
This final rule adopts, without change, an interim final rule with request for comments published in the Federal Register on June 17, 2019, placing solriamfetol (2-amino-3-phenylpropyl carbamate), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the Controlled Substances Act. With the issuance of this final rule, the Drug Enforcement Administration maintains solriamfetol, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the CSA.
Importer of Controlled Substances Application: Myoderm
Document Number: 2019-27954
Type: Notice
Date: 2019-12-27
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Siegfried USA, LLC
Document Number: 2019-27953
Type: Notice
Date: 2019-12-27
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals Inc.
Document Number: 2019-27952
Type: Notice
Date: 2019-12-27
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Pharmaceutical Materials Inc.
Document Number: 2019-27951
Type: Notice
Date: 2019-12-27
Agency: Drug Enforcement Administration, Department of Justice
Lisa Hamilton, N.P.; Decision and Order
Document Number: 2019-27945
Type: Notice
Date: 2019-12-27
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Kinetochem LLC
Document Number: 2019-27784
Type: Notice
Date: 2019-12-26
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturers of Marihuana: Royal Emerald Pharmaceuticals Research and Development
Document Number: 2019-27783
Type: Notice
Date: 2019-12-26
Agency: Drug Enforcement Administration, Department of Justice
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 classes of controlled substances listed in schedule I. Prior to making decisions on this and other pending applications, DEA intends to promulgate regulations that govern the program of growing marihuana for scientific and medical research under DEA registration.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturers of Marihuana: Stanley Brothers Bio Tec Inc.
Document Number: 2019-27782
Type: Notice
Date: 2019-12-26
Agency: Drug Enforcement Administration, Department of Justice
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 classes of controlled substances listed in schedule I. Prior to making decisions on this and other pending applications, DEA intends to promulgate regulations that govern the program of growing marihuana for scientific and medical research under DEA registration.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturers of Marihuana: Agronomed Pharmaceuticals
Document Number: 2019-27781
Type: Notice
Date: 2019-12-26
Agency: Drug Enforcement Administration, Department of Justice
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 classes of controlled substances listed in schedule I. Prior to making decisions on this and other pending applications, DEA intends to promulgate regulations that govern the program of growing marihuana for scientific and medical research under DEA registration.
Technical Correction to Regulation Regarding Registration
Document Number: 2019-27097
Type: Rule
Date: 2019-12-16
Agency: Drug Enforcement Administration, Department of Justice
This final rule corrects an erroneous cross-reference in a Drug Enforcement Administration regulation involving registration and ocean vessels, aircraft, and other entities. This change will provide clarity.
Jeffrey D. Olsen, M.D.; Decision and Order
Document Number: 2019-27096
Type: Notice
Date: 2019-12-16
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Novitium Pharma LLC
Document Number: 2019-27095
Type: Notice
Date: 2019-12-16
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc.
Document Number: 2019-27094
Type: Notice
Date: 2019-12-16
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Meridian Medical Technologies
Document Number: 2019-27093
Type: Notice
Date: 2019-12-16
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 2020
Document Number: 2019-26119
Type: Notice
Date: 2019-12-02
Agency: Drug Enforcement Administration, Department of Justice
This final order establishes the initial 2020 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.
Importer of Controlled Substances Application: Janssen Pharmaceuticals, Inc.
Document Number: 2019-25407
Type: Notice
Date: 2019-11-22
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Epic Pharma, LLC
Document Number: 2019-25406
Type: Notice
Date: 2019-11-22
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mylan Technologies Inc.
Document Number: 2019-25405
Type: Notice
Date: 2019-11-22
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: GE Healthcare
Document Number: 2019-25404
Type: Notice
Date: 2019-11-22
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Fresenius Kabi USA, LLC
Document Number: 2019-25403
Type: Notice
Date: 2019-11-22
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: S&B Pharma, Inc.
Document Number: 2019-25402
Type: Notice
Date: 2019-11-22
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.
Document Number: 2019-25401
Type: Notice
Date: 2019-11-22
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals
Document Number: 2019-25400
Type: Notice
Date: 2019-11-22
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Rhodes Technologies
Document Number: 2019-24545
Type: Notice
Date: 2019-11-12
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cambridge Isotope Lab
Document Number: 2019-24544
Type: Notice
Date: 2019-11-12
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City
Document Number: 2019-24543
Type: Notice
Date: 2019-11-12
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Solriamfetol in Schedule IV
Document Number: C1-2019-12723
Type: Rule
Date: 2019-11-08
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceuticals, Inc.
Document Number: 2019-24108
Type: Notice
Date: 2019-11-05
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Organix, Inc.
Document Number: 2019-24107
Type: Notice
Date: 2019-11-05
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Noramco Inc.
Document Number: 2019-24106
Type: Notice
Date: 2019-11-05
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2019-24105
Type: Notice
Date: 2019-11-05
Agency: Drug Enforcement Administration, Department of Justice
The registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of schedule I and II controlled substances. The companies listed below applied to be registered as an importers of various basic classes of schedule I and II controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted and no requests for a hearing were submitted for these notices.
Schedules of Controlled Substances: Placement of FUB-AMB in Schedule I
Document Number: 2019-23626
Type: Proposed Rule
Date: 2019-10-30
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing methyl 2- (1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutano ate (other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA), 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 make permanent the existing 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 FUB-AMB.
Schedules of Controlled Substances: Extension of Temporary Placement of FUB-AMB in Schedule I of the Controlled Substances Act
Document Number: 2019-23372
Type: Rule
Date: 2019-10-30
Agency: Drug Enforcement Administration, Department of Justice
The Acting Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of a synthetic cannabinoid, methyl 2-(1-(4- fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA), including its optical, positional and geometric isomers, salts, and salts of isomers. The schedule I status of FUB-AMB currently is in effect until November 4, 2019. This temporary order will extend the temporary scheduling of FUB- AMB for one year, or until the permanent scheduling action for this substance is completed, whichever occurs first.