Drug Enforcement Administration 2023 – Federal Register Recent Federal Regulation Documents
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Bulk Manufacturer of Controlled Substances Application: Kinetochem LLC
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
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.
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
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.
Specific Listing for Three Currently Controlled Schedule I Substances
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
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
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
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
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
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
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
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
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
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
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: Organix Chemistry Solutions, LLC
Organix Chemistry Solutions, 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
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.
Bulk Manufacturer of Controlled Substances Application: Groff NA Hemplex LLC
Groff NA Hemplex 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: VHG Labs DBA LGC Standards
VHG Labs DBA LGC Standards 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: Sigma Aldrich Research Biochemicals, Inc.
Sigma Aldrich Research Biochemicals, 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.
Bulk Manufacturer of Controlled Substances Application: Curia Missouri, Inc.
Curia Missouri 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: Noramco
Noramco 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: Noramco
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: Groff NA Hemplex LLC
Groff NA Hemplex 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: Mylan Technologies Inc.
Mylan Technologies Inc. as 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.
Proposed 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
The Drug Enforcement Administration (DEA) proposes to establish the 2024 aggregate production quotas (APQ) for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs (AAN) for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. For the 2024 quota year, DEA intends to allocate procurement quotas to DEA-registered manufacturers of schedule II controlled substances on a quarterly basis. In order to address domestic drug shortages of controlled substances, procurement quota allocations will be divided between quantities authorized for domestic sales and quantities authorized for export sales.
Proposed Adjustments to the 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 2023
The Drug Enforcement Administration (DEA) proposes to adjust the 2023 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemical phenylpropanolamine.
Designation of Halides of 4-Anilinopiperidine as List I Chemicals
The Drug Enforcement Administration (DEA) is finalizing the modification of the listing of the list I chemical, N-phenylpiperidin- 4-amine (also known as 4-anilinopiperidine; N-phenyl-4-piperidinamine; 4-AP) (hereinafter referred to as 4-anilinopiperidine), to include halides of 4-anilinopiperidine. This rule finalizes the modification of the listing of 4-anilinopiperidine as a list I chemical.
Controlled Substance Destruction Alternatives to Incineration
The Drug Enforcement Administration (DEA) is seeking information about destruction processes which may be used to render controlled substances to a non-retrievable state. DEA invites comment from stakeholders in the controlled substance disposal industry, as well as registrants engaged in the destruction and disposal of controlled substances in their possession or inventory, to the questions provided below.
Schedules of Controlled Substances: Placement of Zuranolone in Schedule IV
On August 4, 2023, the United States Food and Drug Administration approved a new drug application for ZURZUVAE (zuranolone) capsules for the treatment of post-partum depression. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place zuranolone and its salts in schedule IV of the Controlled Substances Act (CSA). In accordance with the CSA, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing zuranolone, including its salts, in schedule IV of the CSA. This action facilitates the public availability of zuranolone as a schedule IV controlled substance.
Schedules of Controlled Substances: Temporary Placement of N-Desethyl Isotonitazene and N-Piperidinyl Etonitazene in Schedule I
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule two 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 two specified substances.
Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals
The Controlled Substances Act provides for civil penalties for the distribution of a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, if that distribution was made with reckless disregard for the illegal uses to which such laboratory supply will be put. The term laboratory supply is defined as a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General which contains chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals. The Drug Enforcement Administration is hereby publishing a final notice to update the Special Surveillance List.
Additions to Listing of Exempt Chemical Mixtures
Under this direct final rule, the Drug Enforcement Administration (DEA) is updating the Table of Exempt Chemical Mixtures to include the listing of nine additional preparations. This action is in response to DEA's review of new applications for exemption. Having reviewed applications and relevant information, DEA has found that these preparations meet the applicable exemption criteria. Therefore, this rule amends the regulations to codify that these products are exempted from the application of certain provisions of the Controlled Substances Act.
Importer of Controlled Substances Application: Nexus Pharmaceuticals, Inc.
Nexus 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: Fresenius Kabi USA, LLC
Fresenius Kabi 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.
Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company
Cayman Chemical 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.
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