Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

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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.
Lesly Pompy, M.D.; Decision and Order
Document Number: 2019-23503
Type: Notice
Date: 2019-10-28
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Catalent CTS, LLC
Document Number: 2019-23502
Type: Notice
Date: 2019-10-28
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2019-23501
Type: Notice
Date: 2019-10-28
Agency: Drug Enforcement Administration, Department of Justice
The registrants listed below have applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of a various classes of schedule I and II controlled substances.
[Bulk Manufacturer of Controlled Substances Registration
Document Number: 2019-23500
Type: Notice
Date: 2019-10-28
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 bulk manufacturers of various classes of schedule I and II controlled substances.
Bulk Manufacturer of Controlled Substances Application: Euticals Inc.
Document Number: 2019-23499
Type: Notice
Date: 2019-10-28
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Cyclopropyl Fentanyl, Methoxyacetyl fentanyl, ortho-Fluorofentanyl, and para-Fluorobutyryl Fentanyl in Schedule I
Document Number: 2019-23348
Type: Rule
Date: 2019-10-25
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final order, the Acting Administrator of the Drug Enforcement Administration maintains the placement of the substances cyclopropyl fentanyl (N-(1- phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide), methoxyacetyl fentanyl (2-methoxy-N-(1-phenethylpiperidin-4-yl)-N- phenylacetamide), ortho-fluorofentanyl (N-(2-fluorophenyl)-N-(1- phenethylpiperidin-4-yl)propionamide), and para-fluorobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide), including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. This scheduling action discharges the United States' obligations under the Single Convention on Narcotic Drugs (1961). This action continues to 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 or conduct instructional activities with, or possess), or propose to handle, cyclopropyl fentanyl, methoxyacetyl fentanyl, ortho- fluorofentanyl, and para-fluorobutyryl fentanyl.
Management of Quotas for Controlled Substances and List I Chemicals
Document Number: 2019-21989
Type: Proposed Rule
Date: 2019-10-23
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes to revise existing regulations that manage the quotas for controlled substances and the list I chemicals, ephedrine, pseudoephedrine, and phenylpropanolamine, held by DEA-registered manufacturers. This rule is being proposed to: Define the types of quotas, update the method to abandon quota, clarify the current language to ensure that both manufacturers and distributors are required to obtain certification of a buyer's quota, reduce overall inventories, formalize the existing practice of use-specific subcategories for individual manufacturing and procurement quotas, and modify existing deadlines to fix/issue quotas. The DEA is also amending certain regulations to implement updates to the Controlled Substances Act made by the Substance Use-Disorder Prevention that Promotes Opioid Recovery Treatment for Patients and Communities Act. The DEA emphasizes that all of these revisions and amendments would apply to both bulk and dosage-form manufacturers, as well as importers of the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The changes are necessary to reduce the potential for diversion, and would align regulations with current manufacturing business practices.
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey, Inc.
Document Number: 2019-23012
Type: Notice
Date: 2019-10-22
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Applications: Bulk Manufacturers of Marihuana; Correction
Document Number: 2019-22312
Type: Notice
Date: 2019-10-11
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) published a document in the Federal Register on August 27, 2019, concerning a notice of applications. As that document correctly indicated, each of the applicants noticed applied to be registered with DEA to grow marihuana as a bulk manufacturer. However, certain drug codes for some of the applicants were inadvertently omitted by DEA or not listed because applicants had inadvertently omitted them from their applications.
Importer of Controlled Substances Application: Cambridge Isotope Laboratories, Inc.
Document Number: 2019-21829
Type: Notice
Date: 2019-10-07
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2019-21321
Type: Notice
Date: 2019-10-01
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.
Importer of Controlled Substances Application: Noramco Inc.
Document Number: 2019-21320
Type: Notice
Date: 2019-10-01
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Noramco, Inc.
Document Number: 2019-21319
Type: Notice
Date: 2019-10-01
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration; Siemens Healthcare Diagnostics, Inc.
Document Number: 2019-21313
Type: Notice
Date: 2019-10-01
Agency: Drug Enforcement Administration, Department of Justice
The registrants listed below have applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of various classes of schedule I and II controlled substances.
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2019-21312
Type: Notice
Date: 2019-10-01
Agency: Drug Enforcement Administration, Department of Justice
The registrants listed below have applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of a various classes of schedule I and II controlled substances.