Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

Results 401 - 450 of 4,287
Exempt Chemical Preparations Under the Controlled Substances Act
Document Number: C1-2022-01112
Type: Notice
Date: 2022-02-03
Agency: Drug Enforcement Administration, Department of Justice
Bradley H. Chesler, M.D.; Decision and Order
Document Number: 2022-01838
Type: Notice
Date: 2022-01-31
Agency: Drug Enforcement Administration, Department of Justice
Austin J. Kosier, M.D.; Decision and Order
Document Number: 2022-01834
Type: Notice
Date: 2022-01-31
Agency: Drug Enforcement Administration, Department of Justice
Michael E. Smith, D.V.M.; Decision and Order
Document Number: 2022-01840
Type: Notice
Date: 2022-01-31
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc.
Document Number: 2022-01817
Type: Notice
Date: 2022-01-31
Agency: Drug Enforcement Administration, Department of Justice
Mylan Pharmaceuticals Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC
Document Number: 2022-01816
Type: Notice
Date: 2022-01-31
Agency: Drug Enforcement Administration, Department of Justice
Siegfried USA, LLC. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Navinta LLC
Document Number: 2022-01815
Type: Notice
Date: 2022-01-31
Agency: Drug Enforcement Administration, Department of Justice
Navinta LLC, has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Importer of Controlled Substances Application: Globyz Pharma, LLC; Correction
Document Number: 2022-00852
Type: Notice
Date: 2022-01-24
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) published a document in the Federal Register on August 12, 2021, concerning a notice of application. The document indicated the approved drug code (1205 Lisdexamfetamine) as a schedule I. The correct drug schedule should read schedule II.
Daniel R. Nevarre, M.D.; Decision and Order
Document Number: 2022-01112
Type: Notice
Date: 2022-01-21
Agency: Drug Enforcement Administration, Department of Justice
Alex E. Torres, M.D.; Decision and Order
Document Number: 2022-01109
Type: Notice
Date: 2022-01-21
Agency: Drug Enforcement Administration, Department of Justice
Stephen E. Owusu, D.P.M.; Decision and Order
Document Number: 2022-01108
Type: Notice
Date: 2022-01-21
Agency: Drug Enforcement Administration, Department of Justice
Exempt Chemical Preparations Under the Controlled Substances Act
Document Number: 2022-01125
Type: Notice
Date: 2022-01-21
Agency: Drug Enforcement Administration, Department of Justice
The applications for exempt chemical preparations received by the Drug Enforcement Administration between April 1, 2021, and June 30, 2021, as listed below, were accepted for filing and have been approved or denied as indicated.
Tel-Pharmacy; Decision and Order
Document Number: 2022-00956
Type: Notice
Date: 2022-01-19
Agency: Drug Enforcement Administration, Department of Justice
AARRIC, Inc. d/b/a at Cost RX; Decision and Order
Document Number: 2022-00955
Type: Notice
Date: 2022-01-19
Agency: Drug Enforcement Administration, Department of Justice
Samson K. Orusa, M.D.; Decision and Order
Document Number: 2022-00952
Type: Notice
Date: 2022-01-19
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of 4-hydroxy-N,N
Document Number: 2022-00713
Type: Proposed Rule
Date: 2022-01-14
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing five tryptamine hallucinogens, as identified in this proposed rule, 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, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle these five specific controlled substances.
Importer of Controlled Substances Application: Organic Standards Solutions International, LLC
Document Number: 2022-00652
Type: Notice
Date: 2022-01-14
Agency: Drug Enforcement Administration, Department of Justice
Organic Standards Solutions International, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Importer of Controlled Substances Application: Nexus Pharmaceuticals, Inc.
Document Number: 2022-00329
Type: Notice
Date: 2022-01-11
Agency: Drug Enforcement Administration, Department of Justice
Nexus Pharmaceuticals, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey, Inc.
Document Number: 2022-00326
Type: Notice
Date: 2022-01-11
Agency: Drug Enforcement Administration, Department of Justice
Johnson Matthey, Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Curia Missouri Inc.
Document Number: 2022-00325
Type: Notice
Date: 2022-01-11
Agency: Drug Enforcement Administration, Department of Justice
Curia Missouri Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Gulf Med Pharmacy; Decision and Order
Document Number: 2021-27718
Type: Notice
Date: 2021-12-22
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Organix Inc.
Document Number: 2021-27635
Type: Notice
Date: 2021-12-21
Agency: Drug Enforcement Administration, Department of Justice
Organix Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Washington Bryan, M.D.; Decision and Order
Document Number: 2021-27431
Type: Notice
Date: 2021-12-20
Agency: Drug Enforcement Administration, Department of Justice
Peter S. Klainer, M.D.; Decision and Order
Document Number: 2021-27430
Type: Notice
Date: 2021-12-20
Agency: Drug Enforcement Administration, Department of Justice
Cypress Creek Pharmacy, LLC; Order
Document Number: 2021-27486
Type: Notice
Date: 2021-12-20
Agency: Drug Enforcement Administration, Department of Justice
Timothy C. Sapp, M.D.; Decision and Order
Document Number: 2021-27485
Type: Notice
Date: 2021-12-20
Agency: Drug Enforcement Administration, Department of Justice
Medical Pharmacy Decision and Order
Document Number: 2021-27416
Type: Notice
Date: 2021-12-20
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: SpecGX, LLC
Document Number: 2021-26907
Type: Notice
Date: 2021-12-13
Agency: Drug Enforcement Administration, Department of Justice
SpecGX, LLC, has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Importer of Controlled Substances Application: Noramco, Inc.
Document Number: 2021-26906
Type: Notice
Date: 2021-12-13
Agency: Drug Enforcement Administration, Department of Justice
Noramco, Inc., has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC
Document Number: 2021-26678
Type: Notice
Date: 2021-12-09
Agency: Drug Enforcement Administration, Department of Justice
Catalent Pharma Solutions, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Importer of Controlled Substances Application: Fresenius Kabi USA, LLC
Document Number: 2021-26677
Type: Notice
Date: 2021-12-09
Agency: Drug Enforcement Administration, Department of Justice
Fresenius Kabi USA, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Noramco Coventry LLC
Document Number: 2021-26676
Type: Notice
Date: 2021-12-09
Agency: Drug Enforcement Administration, Department of Justice
Noramco Coventry LLC, has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Tamika Mayo, M.D.; Decision and Order
Document Number: 2021-26533
Type: Notice
Date: 2021-12-08
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Methoxetamine (MXE) in Schedule I
Document Number: 2021-26293
Type: Proposed Rule
Date: 2021-12-07
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing 2- (ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-one (methoxetamine, MXE), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, in schedule I of the Controlled Substances Act. This action is being taken to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. 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, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle, methoxetamine.
Schedules of Controlled Substances: Temporary Placement of Butonitazene, Etodesnitazene, Flunitazene, Metodesnitazene, Metonitazene, N-pyrrolidino etonitazene, and Protonitazene in Schedule I
Document Number: 2021-26263
Type: Proposed Rule
Date: 2021-12-07
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 synthetic benzimidazole-opioid substances, 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. When it is issued, the temporary scheduling order will impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances 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 these seven specified controlled substances.
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2021-26364
Type: Notice
Date: 2021-12-06
Agency: Drug Enforcement Administration, Department of Justice
Fisher Clinical Services, Inc., has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Kinetochem LLC
Document Number: 2021-26363
Type: Notice
Date: 2021-12-06
Agency: Drug Enforcement Administration, Department of Justice
Kinetochem LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Importer of Controlled Substances Application: Johnson Matthey Inc.
Document Number: 2021-26361
Type: Notice
Date: 2021-12-06
Agency: Drug Enforcement Administration, Department of Justice
Johnson Matthey Inc., has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
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 2022
Document Number: 2021-26227
Type: Notice
Date: 2021-12-02
Agency: Drug Enforcement Administration, Department of Justice
This final order establishes the initial 2022 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: IsoSciences, LLC
Document Number: 2021-25954
Type: Notice
Date: 2021-11-29
Agency: Drug Enforcement Administration, Department of Justice
IsoSciences, LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.
Document Number: 2021-25950
Type: Notice
Date: 2021-11-29
Agency: Drug Enforcement Administration, Department of Justice
Patheon API Manufacturing, Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Pisgah Laboratories Inc.
Document Number: 2021-25949
Type: Notice
Date: 2021-11-29
Agency: Drug Enforcement Administration, Department of Justice
Pisgah Laboratories Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Noramco
Document Number: 2021-25578
Type: Notice
Date: 2021-11-23
Agency: Drug Enforcement Administration, Department of Justice
Noramco, has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Importer of Controlled Substances Application: Mylan Technologies, Inc.
Document Number: 2021-25575
Type: Notice
Date: 2021-11-23
Agency: Drug Enforcement Administration, Department of Justice
Mylan Technologies, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Pronto Pharmacy, LLC; Decision and Order
Document Number: 2021-25133
Type: Notice
Date: 2021-11-18
Agency: Drug Enforcement Administration, Department of Justice
Designation of Methyl alpha-phenylacetoacetate, a Precursor Chemical Used in the Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as a List I Chemical
Document Number: 2021-24952
Type: Rule
Date: 2021-11-18
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is finalizing, without change, a March 30, 2021, notice of proposed rulemaking to designate the chemical methyl alpha-phenylacetoacetate (also known as MAPA; methyl 3-oxo-2-phenylbutanoate; methyl 2-phenylacetoacetate; [alpha]- acetyl-benzeneacetic acid, methyl ester; and CAS Number: 16648-44-5) and its optical isomers as a list I chemical under the Controlled Substances Act (CSA). Methyl alpha-phenylacetoacetate is used in clandestine laboratories to illicitly manufacture the schedule II controlled substances phenylacetone (also known as phenyl-2-propanone, P2P, or benzyl methyl ketone), methamphetamine, and amphetamine and is important to the manufacture of these controlled substances. This final rulemaking subjects handlers (manufacturers, distributors, importers, and exporters) of MAPA to the chemical regulatory provisions of the CSA and its implementing regulations.
Regulation of Telepharmacy Practice
Document Number: 2021-24948
Type: Proposed Rule
Date: 2021-11-17
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is issuing this advanced notice of proposed rulemaking to obtain further information regarding the practice of telepharmacy. Telepharmacy is not specifically defined by the Controlled Substances Act (CSA) or DEA regulations; however, to the extent telepharmacies dispense controlled substances, they are under the purview of the CSA and DEA. DEA is considering promulgating regulations regarding telepharmacy and seeks to be fully informed about the practice, industry, and state regulation of telepharmacy.
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 2021
Document Number: 2021-24921
Type: Notice
Date: 2021-11-15
Agency: Drug Enforcement Administration, Department of Justice
This final order establishes the final adjusted 2021 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.
Larry C. Daniels, M.D.; Decision and Order
Document Number: 2021-24206
Type: Notice
Date: 2021-11-05
Agency: Drug Enforcement Administration, Department of Justice
George Roussis, M.D.; Decision and Order
Document Number: 2021-24205
Type: Notice
Date: 2021-11-05
Agency: Drug Enforcement Administration, Department of Justice
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