Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

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Schedules of Controlled Substances: Placement of 2-Methyl AP-237 in Schedule I
Document Number: 2024-05543
Type: Rule
Date: 2024-03-15
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final order, the Administrator of the Drug Enforcement Administration is permanently placing 1-(2-methyl- 4-(3-phenylprop-2-en-1-yl)piperazin-1-yl)butan-1-one (commonly known as 2-methyl AP-237), including its optical and geometric isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, 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 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 2-methyl AP-237.
Mark Fenzl, D.O.; Decision and Order
Document Number: 2024-05099
Type: Notice
Date: 2024-03-11
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Sterling Pharma USA LLC
Document Number: 2024-04747
Type: Notice
Date: 2024-03-06
Agency: Drug Enforcement Administration, Department of Justice
Sterling Pharma 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: Bulk Manufacturer of Marihuana: Nusachi Labs, LLC
Document Number: 2024-04743
Type: Notice
Date: 2024-03-06
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 class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.
Importer of Controlled Substances Application: Benuvia Operations, LLC
Document Number: 2024-04757
Type: Notice
Date: 2024-03-06
Agency: Drug Enforcement Administration, Department of Justice
Benuvia Operations, 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: Sigma Aldrich Company LLC
Document Number: 2024-04756
Type: Notice
Date: 2024-03-06
Agency: Drug Enforcement Administration, Department of Justice
Sigma Aldrich Company 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.
Bulk Manufacturer of Controlled Substances Application: Organic Consultants LLC DBA Cascade Chemistry
Document Number: 2024-04755
Type: Notice
Date: 2024-03-06
Agency: Drug Enforcement Administration, Department of Justice
Organic Consultants LLC DBA Cascade Chemistry 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: Stepan Company
Document Number: 2024-04754
Type: Notice
Date: 2024-03-06
Agency: Drug Enforcement Administration, Department of Justice
Stepan Company 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: AndersonBrecon Inc. dba PCI Pharma Services
Document Number: 2024-04753
Type: Notice
Date: 2024-03-06
Agency: Drug Enforcement Administration, Department of Justice
AndersonBrecon Inc. dba PCI Pharma Services 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: S&B Pharma LLC
Document Number: 2024-03719
Type: Notice
Date: 2024-02-23
Agency: Drug Enforcement Administration, Department of Justice
S&B Pharma 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: S&B Pharma LLC DBA Norac Pharma
Document Number: 2024-03718
Type: Notice
Date: 2024-02-23
Agency: Drug Enforcement Administration, Department of Justice
S&B Pharma LLC DBA Norac Pharma 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: Meridian Medical Technologies, LLC
Document Number: 2024-03714
Type: Notice
Date: 2024-02-23
Agency: Drug Enforcement Administration, Department of Justice
Meridian Medical Technologies, 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.
Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics Inc.
Document Number: 2024-03712
Type: Notice
Date: 2024-02-23
Agency: Drug Enforcement Administration, Department of Justice
Siemens Healthcare Diagnostics Inc. 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: Patheon API Services, Inc.
Document Number: 2024-03688
Type: Notice
Date: 2024-02-23
Agency: Drug Enforcement Administration, Department of Justice
Patheon API 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: Patheon API Services Inc.
Document Number: 2024-03686
Type: Notice
Date: 2024-02-23
Agency: Drug Enforcement Administration, Department of Justice
Patheon API Services Inc. 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: Pall Life Sciences PR, LLC
Document Number: 2024-03683
Type: Notice
Date: 2024-02-23
Agency: Drug Enforcement Administration, Department of Justice
Pall Life Sciences PR, 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: Pfizer, Inc.
Document Number: 2024-03709
Type: Notice
Date: 2024-02-23
Agency: Drug Enforcement Administration, Department of Justice
Pfizer, 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: Janssen Pharmaceuticals Inc.
Document Number: 2024-03689
Type: Notice
Date: 2024-02-23
Agency: Drug Enforcement Administration, Department of Justice
Janssen 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.
Henry Manning Pickett, M.D.; Default Decision and Order
Document Number: 2024-03548
Type: Notice
Date: 2024-02-22
Agency: Drug Enforcement Administration, Department of Justice
Conforming Amendment Regarding the Veterinary Medicine Mobility Act of 2014
Document Number: 2024-02322
Type: Rule
Date: 2024-02-08
Agency: Drug Enforcement Administration, Department of Justice
The Veterinary Medicine Mobility Act of 2014 (VMMA), which became law on August 1, 2014, amended the Controlled Substances Act to address separate registration requirements for veterinarians. The VMMA allows a veterinarian to transport and dispense controlled substances in the usual course of veterinary practice at a site other than the veterinarian's registered principal place of business or professional practice without obtaining a separate registration, subject to certain limitations. The Drug Enforcement Administration is amending its regulations to codify the VMMA. This rule merely conforms DEA regulations to statutory amendments of the Controlled Substances Act that have already taken effect and makes no substantive change to existing legal requirements.
Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc.
Document Number: 2024-01137
Type: Notice
Date: 2024-01-23
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.
Importer of Controlled Substances Application: Mylan Inc.
Document Number: 2024-01136
Type: Notice
Date: 2024-01-23
Agency: Drug Enforcement Administration, Department of Justice
Mylan 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: Invizyne Technologies, Inc.
Document Number: 2024-01135
Type: Notice
Date: 2024-01-23
Agency: Drug Enforcement Administration, Department of Justice
Invizyne Technologies, 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.
Importer of Controlled Substances Application: Myonex Inc.
Document Number: 2024-01134
Type: Notice
Date: 2024-01-23
Agency: Drug Enforcement Administration, Department of Justice
Myonex 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: Medi-Physics Inc. DBA GE Healthcare
Document Number: 2024-01133
Type: Notice
Date: 2024-01-23
Agency: Drug Enforcement Administration, Department of Justice
Medi-Physics Inc. DBA GE Healthcare 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: Maridose, LLC
Document Number: 2024-01132
Type: Notice
Date: 2024-01-23
Agency: Drug Enforcement Administration, Department of Justice
Maridose, 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: Arista Biologicals
Document Number: 2024-00994
Type: Notice
Date: 2024-01-19
Agency: Drug Enforcement Administration, Department of Justice
Arista Biologicals 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: Siegfried USA, LLC
Document Number: 2024-00990
Type: Notice
Date: 2024-01-19
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.
Controlled Substance Destruction Alternatives to Incineration; Extension of Comment Period
Document Number: 2023-28964
Type: Proposed Rule
Date: 2024-01-03
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) published an advance notice of proposed rulemaking entitled ``Controlled Substance Destruction Alternatives to Incineration'' in the Federal Register on October 31, 2023. DEA is extending the comment period on that advance notice until April 1, 2024.
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 2024
Document Number: 2023-28962
Type: Notice
Date: 2024-01-03
Agency: Drug Enforcement Administration, Department of Justice
This final order establishes the initial 2024 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.
Mark Young, M.D.; Decision and Order
Document Number: 2023-28016
Type: Notice
Date: 2023-12-21
Agency: Drug Enforcement Administration, Department of Justice
Frank A. Hooper, D.V.M.; Decision and Order
Document Number: 2023-28015
Type: Notice
Date: 2023-12-21
Agency: Drug Enforcement Administration, Department of Justice
Joeseph Potter, D.D.S.; Decision and Order
Document Number: 2023-28013
Type: Notice
Date: 2023-12-21
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Kinetochem LLC
Document Number: 2023-27708
Type: Notice
Date: 2023-12-18
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.
Bulk Manufacturer of Controlled Substances Application: AJNA BioSciences
Document Number: 2023-27707
Type: Notice
Date: 2023-12-18
Agency: Drug Enforcement Administration, Department of Justice
AJNA BioSciences 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: Groff Health, Inc.
Document Number: 2023-27706
Type: Notice
Date: 2023-12-18
Agency: Drug Enforcement Administration, Department of Justice
Groff Health, Inc. 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: Siegfried USA, LLC
Document Number: 2023-27705
Type: Notice
Date: 2023-12-18
Agency: Drug Enforcement Administration, Department of Justice
Siegfried USA, 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.
APEXX Pharmacy, LLC; Decision and Order
Document Number: 2023-27524
Type: Notice
Date: 2023-12-15
Agency: Drug Enforcement Administration, Department of Justice
Gary R. Wisner, M.D.; Decision and Order
Document Number: 2023-27522
Type: Notice
Date: 2023-12-15
Agency: Drug Enforcement Administration, Department of Justice
Specific Listing for Three Currently Controlled Schedule I Substances
Document Number: 2023-27292
Type: Rule
Date: 2023-12-13
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is establishing a specific listing and DEA Controlled Substances Code Number (drug code) for three substances: N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-butyl- 1H-indazole-3-carboxamide (also known as ADB-BUTINACA); 4-methyl-1- phenyl-2-(pyrrolidin-1-yl)pentan-1-one (also known as [alpha]-PiHP or alpha-PiHP); and 2-(methylamino)-1-(3-methylphenyl)propan-1-one (also known as 3-MMC or 3-methylmethcathinone) in schedule I of the Controlled Substances Act (CSA). Although ADB-BUTINACA, [alpha]-PiHP, and 3-MMC are not specifically listed in schedule I of the CSA with their own unique drug codes, they are schedule I controlled substances in the United States because they are positional isomers of AB-PINACA (controlled January 30, 2015), [alpha]-PHP (controlled July 18, 2019), and mephedrone (controlled as a hallucinogen July 9, 2012), respectively, each of which are schedule I hallucinogens. Therefore, DEA is simply amending the schedule I hallucinogenic substances list in its regulations to separately include ADB-BUTINACA, [alpha]-PiHP, and 3-MMC.
Schedules of Controlled Substances: Placement of 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) in Schedule I
Document Number: 2023-27289
Type: Proposed Rule
Date: 2023-12-13
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing two phenethylamine hallucinogens, as identified in this proposed rule, in schedule I of the Controlled Substances Act. This action is being taken, in part, to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances for one of these substances 2,5-dimethoxy-4-chloroamphetamine. 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 two specific controlled substances.
Schedules of Controlled Substances: Temporary Placement of MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA into Schedule I
Document Number: 2023-27243
Type: Rule
Date: 2023-12-12
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this temporary order to schedule six synthetic cannabinoids and their optical and geometric isomers, salts, and salts of isomers, whenever the existence of such isomers and salts is possible, in schedule I under the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of these six substances in schedule I is necessary to avoid 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 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 six specified controlled substances.
Schedules of Controlled Substances: Placement of Nine Specific Fentanyl-Related Substances in Schedule I
Document Number: 2023-26694
Type: Rule
Date: 2023-12-07
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Drug Enforcement Administration places nine fentanyl-related substances, as identified in this final rule, 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. These nine fentanyl-related substances are currently listed in schedule I pursuant to a temporary scheduling order. This action makes permanent 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 with, or possess), or propose to handle these nine specific fentanyl-related controlled substances.
Importer of Controlled Substances Application: Caligor Coghlan Pharma Services
Document Number: 2023-26558
Type: Notice
Date: 2023-12-04
Agency: Drug Enforcement Administration, Department of Justice
Caligor Coghlan Pharma Services, 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: Restek Corporation
Document Number: 2023-26555
Type: Notice
Date: 2023-12-04
Agency: Drug Enforcement Administration, Department of Justice
Restek Corporation 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: Element Materials Technology Santa Rosa
Document Number: 2023-26553
Type: Notice
Date: 2023-12-04
Agency: Drug Enforcement Administration, Department of Justice
Element Materials Technology Santa Rosa 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: Pharmaron Manufacturing Services (US) LLC
Document Number: 2023-26343
Type: Notice
Date: 2023-11-30
Agency: Drug Enforcement Administration, Department of Justice
Pharmaron Manufacturing Services (US) 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: Pharmaron Manufacturing Services (US) LLC
Document Number: 2023-26342
Type: Notice
Date: 2023-11-30
Agency: Drug Enforcement Administration, Department of Justice
Pharmaron Manufacturing Services (US) 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: Organic Standards Solutions International, LLC
Document Number: 2023-25948
Type: Notice
Date: 2023-11-24
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.
Bulk Manufacturer of Controlled Substances Application: Isosciences, LLC
Document Number: 2023-25947
Type: Notice
Date: 2023-11-24
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.
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