Drug Enforcement Administration August 2020 – Federal Register Recent Federal Regulation Documents
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Schedules of Controlled Substances: Extension of Temporary Placement of N-Ethylpentylone in Schedule I of the Controlled Substances Act
The Acting Administrator of the Drug Enforcement Administration is issuing this order to extend the temporary schedule I status of a synthetic cathinone, 1-(1,3-benzodioxol-5-yl)-2- (ethylamino)pentan-1-one (N-ethylpentylone, ephylone), including its optical, positional and geometric isomers, salts, and salts of isomers. The schedule I status of N-ethylpentylone currently is in effect until August 31, 2020. This order extends the temporary scheduling of N- ethylpentylone for one year, or until the permanent scheduling action for this substance is completed, whichever occurs first.
Schedules of Controlled Substances: Placement of N-Ethylpentylone in Schedule I
The Drug Enforcement Administration proposes placing 1-(1,3- benzodioxol-5-yl)-2-(ethylamino)pentan-1-one (N-ethylpentylone, ephylone) and its optical, positional, and geometric isomers, salts, 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, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle N-ethylpentylone.
Implementation of the Agriculture Improvement Act of 2018
The purpose of this interim final rule is to codify in the Drug Enforcement Administration (DEA) regulations the statutory amendments to the Controlled Substances Act (CSA) made by the Agriculture Improvement Act of 2018 (AIA), regarding the scope of regulatory controls over marihuana, tetrahydrocannabinols, and other marihuana-related constituents. This interim final rule merely conforms DEA's regulations to the statutory amendments to the CSA that have already taken effect, and it does not add additional requirements to the regulations.
Schedules of Controlled Substances: Temporary Placement of Isotonitazene in Schedule I
The Acting Administrator of the Drug Enforcement Administration is issuing this temporary order to schedule N,N-diethyl- 2-(2-(4 isopropoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)ethan-1-amine (commonly known as isotonitazene), including its 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. This action is based on a finding by the Acting Administrator that the placement of isotonitazene in schedule I of the Controlled Substances Act is necessary to avoid an 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 will be imposed 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 isotonitazene.
Schedules of Controlled Substances: Placement of Cenobamate in Schedule V
This final rule adopts, without change, an interim final rule with request for comments published in the Federal Register on March 10, 2020, placing cenobamate [(1R)-1-(2-chlorophenyl)-2-(tetrazol-2- yl)ethyl] carbamate, including its salts, in schedule V of the Controlled Substances Act (CSA). With the issuance of this final rule, the Drug Enforcement Administration maintains cenobamate, including its salts, in schedule V of the CSA.
Bulk Manufacturer of Controlled Substances Application: Purisys, LLC
Purisys, LLC applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: Lysergic acid diethylamide and Pentobarbital.
Importer of Controlled Substances Application: GE Healthcare
GE Healthcare applied to be registered as an importer of the following basic class(es) of a controlled substance: Cocaine.
Importer of Controlled Substances Application: Cambrex High Point, Inc.
Cambrex High Point, Inc. applied to be registered as an importer of the following basic class(es) of a controlled substance: Poppy Straw Concentrate.
Importer of Controlled Substances Application: Catalent CTS, LLC
Catalent, CTS LLC applied to be registered as an importer of the following basic class(es) of controlled substances: Gamma Hydroxybutyric Acid, Marihuana Extract, Marihuana, and Tetrahydrocannabinols.
Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals
Cedarburg Pharmaceuticals applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: Tetrahydrocannabinol, Methylphenidate, Nabilone, 4-Anilino-N-phenethyl- 4-piperidine (ANPP), and Fentanyl.
Importer of Controlled Substances Application: Epic Pharma, LLC
Epic Pharma, LLC applied to be registered as an importer of the following basic class(es) of a controlled substance: Methadone.
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