Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

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Schedules of Controlled Substances: Placement of Thiafentanil in Schedule II
Document Number: 2019-12735
Type: Rule
Date: 2019-06-18
Agency: Drug Enforcement Administration, Department of Justice
On August 26, 2016, the Drug Enforcement Administration (DEA) published in the Federal Register an interim final rule with request for comments placing the substance thiafentanil, including its isomers, esters, ethers, salts and salts of isomers, esters and ethers, in schedule II of the Controlled Substances Act. This final rule adopts that interim final rule without change.
Importer of Controlled Substances Registration
Document Number: 2019-12740
Type: Notice
Date: 2019-06-17
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as an importer of schedule I controlled substances.
Schedules of Controlled Substances: Placement of Solriamfetol in Schedule IV
Document Number: 2019-12723
Type: Rule
Date: 2019-06-17
Agency: Drug Enforcement Administration, Department of Justice
On March 20, 2019, the U.S. Food and Drug Administration approved a new drug application for SUNOSI, a drug product consisting of solriamfetol ((R)-2-amino-3-phenylpropyl carbamate hydrochloride) tablets for oral use. Thereafter, the Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place solriamfetol in schedule IV of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing 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.
Schedules of Controlled Substances: Placement of Brexanolone in Schedule IV
Document Number: 2019-12721
Type: Rule
Date: 2019-06-17
Agency: Drug Enforcement Administration, Department of Justice
On March 19, 2019, the U.S. Food and Drug Administration (FDA) approved a new drug application for Zulresso (brexanolone). Brexanolone is chemically known as 3[alpha]-hydroxy-5[alpha]-pregnan-20-one and is also referred to as allopregnanolone. The Department of Health and Human Services (HHS) provided the Drug Enforcement Administration (DEA) with a recommendation that brexanolone be placed in schedule IV of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing brexanolone (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.
Elizabeth C. Korcz, M.D.; Decision and Order
Document Number: 2019-12506
Type: Notice
Date: 2019-06-13
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories
Document Number: 2019-12505
Type: Notice
Date: 2019-06-13
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2019-12504
Type: Notice
Date: 2019-06-13
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of a basic class of schedule II controlled substances.
Bulk Manufacturer of Controlled Substances Application: Sigma Aldrich Research
Document Number: 2019-12503
Type: Notice
Date: 2019-06-13
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2019-11881
Type: Notice
Date: 2019-06-06
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has 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 Application: American Radiolabeled Chem
Document Number: 2019-11878
Type: Notice
Date: 2019-06-06
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: SpecGx LLC
Document Number: 2019-11877
Type: Notice
Date: 2019-06-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Shertech Laboratories, LLC
Document Number: 2019-11876
Type: Notice
Date: 2019-06-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2019-10669
Type: Notice
Date: 2019-05-22
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 schedule II controlled substances.
Importer of Controlled Substances Application: United States Pharmacopeial Convention
Document Number: 2019-10668
Type: Notice
Date: 2019-05-22
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Wildlife Laboratories, Inc.
Document Number: 2019-10030
Type: Notice
Date: 2019-05-15
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2019-10028
Type: Notice
Date: 2019-05-15
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 schedule II controlled substances.
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2019-10026
Type: Notice
Date: 2019-05-15
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 schedule I and II controlled substances.
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2019-10025
Type: Notice
Date: 2019-05-15
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of various classes of schedule I controlled substances.
Fred J. Powell, M.D.; Decision and Order
Document Number: 2019-10019
Type: Notice
Date: 2019-05-15
Agency: Drug Enforcement Administration, Department of Justice
Raquel Skidmore, M.D.; Decision and Order
Document Number: 2019-10015
Type: Notice
Date: 2019-05-15
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2019-10014
Type: Notice
Date: 2019-05-15
Agency: Drug Enforcement Administration, Department of Justice
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of schedule I and II controlled substances.
Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals Virginia, LLC
Document Number: 2019-10013
Type: Notice
Date: 2019-05-15
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Rhodes Technologies
Document Number: 2019-10010
Type: Notice
Date: 2019-05-15
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: S & B Pharma, Inc
Document Number: 2019-10008
Type: Notice
Date: 2019-05-15
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: AndersonBrecon, Inc.
Document Number: 2019-10007
Type: Notice
Date: 2019-05-15
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: AndersonBrecon Inc. DBA PCI of Illinois
Document Number: 2019-10006
Type: Notice
Date: 2019-05-15
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of beta-Hydroxythiofentanyl in Schedule I
Document Number: 2019-09479
Type: Rule
Date: 2019-05-08
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Drug Enforcement Administration places beta-hydroxythiofentanyl (N-[1-[2-hydroxy-2- (thiophen-2-yl)ethyl]piperidin-4-yl]-N-phenylpropionamide), also known as N-[1-[2-hydroxy-2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenyl- propanamide, including its isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. This rule continues 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, or possess), or propose to handle beta-hydroxythiofentanyl.
Schedules of Controlled Substances: Placement of Furanyl Fentanyl, 4-Fluoroisobutyryl Fentanyl, Acryl Fentanyl, Tetrahydrofuranyl Fentanyl, and Ocfentanil in Schedule I; Correction
Document Number: 2019-09477
Type: Rule
Date: 2019-05-08
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is correcting a final order that appeared in the Federal Register on November 29, 2018. The document issued an action maintaining the placement of furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil, including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. A drafting oversight in the amendatory instructions did not correctly update the prefatory language on isomers to reflect the change in the paragraph number for the designation of 3-methylthiofentanyl.
Schedules of Controlled Substances: Temporary Placement of N
Document Number: 2019-08704
Type: Proposed Rule
Date: 2019-05-01
Agency: Drug Enforcement Administration, Department of Justice
The Acting Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule the synthetic cathinones, N-ethylhexedrone; alpha- pyrrolidinohexanophenone (trivial name: [alpha]-PHP); 4-methyl-alpha- ethylaminopentiophenone (trivial name: 4-MEAP); 4'-methyl-alpha- pyrrolidinohexiophenone (trivial name: MPHP); alpha- pyrrolidinoheptaphenone (trivial name: PV8); and 4-chloro-alpha- pyrrolidinovalerophenone (trivial name: 4-chloro-[alpha]-PVP), in schedule I. When it is issued, the temporary scheduling order will impose regulatory requirements under the Controlled Substances Act (CSA) on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, conduct of instructional activities, and chemical analysis of these synthetic cathinones, as well as administrative, civil, and criminal remedies with respect to persons who fail to comply with such requirements or otherwise violate the CSA with respect to these substances.
Interlocutory Appeals in Administrative Hearings
Document Number: 2019-08705
Type: Rule
Date: 2019-04-30
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is amending its hearing regulations to provide that, when the presiding officer of an administrative hearing denies an interlocutory appeal, he shall transmit his determination to the Drug Enforcement Administration Administrator for discretionary review.
Palafox Pharmacy; Decision and Order
Document Number: 2019-08703
Type: Notice
Date: 2019-04-30
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc.
Document Number: 2019-08702
Type: Notice
Date: 2019-04-30
Agency: Drug Enforcement Administration, Department of Justice
Chemical Names of Previously Controlled Fentanyl-Related Substances
Document Number: 2019-07457
Type: Rule
Date: 2019-04-19
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is providing additional descriptive information with respect to five specific substances already covered by a temporary scheduling order that appeared in the Federal Register on February 6, 2018. That order placed fentanyl-related substances temporarily in schedule I of the Controlled Substances Act. The order further stated that if and when DEA identifies a specific new substance that falls under the definition of a fentanyl-related substance, the agency will publish in the Federal Register, and on the agency website, the chemical name of such substance. Consistent therewith, this document provides the chemical names of five substances that fall within the definition of fentanyl- related substances that were temporarily controlled under the scheduling order issued February 6, 2018.
Schedules of Controlled Substances: Temporary Placement of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 into Schedule I
Document Number: 2019-07460
Type: Rule
Date: 2019-04-16
Agency: Drug Enforcement Administration, Department of Justice
The Acting Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic cannabinoids (SC), ethyl 2-(1-(5-fluoropentyl)-1H- indazole-3-carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-EDMB- PINACA); methyl 2-(1-(5-fluoropentyl)-1H-indole-3-carboxamido)-3,3- dimethylbutanoate (trivial name: 5F-MDMB-PICA); N-(adamantan-1-yl)-1- (4-fluorobenzyl)-1H-indazole-3-carboxamide (trivial names: FUB-AKB48; FUB-APINACA; AKB48 N-(4-FLUOROBENZYL)); 1-(5-fluoropentyl)-N-(2- phenylpropan-2-yl)-1H-indazole-3-carboxamide (trivial names: 5F-CUMYL- PINACA; SGT-25); and (1-(4-fluorobenzyl)-1H-indol-3-yl)(2,2,3,3- tetramethylcyclopropyl) methanone (trivial name: FUB-144), and their optical, positional, and geometric isomers, salts, and salts of isomers in schedule I. This action is based on a finding by the Acting Administrator that the placement of these SCs 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, or possess), or propose to handle, 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB- AKB48, 5F-CUMYL-PINACA or FUB-144.
Importer of Controlled Substances Application: Sanyal Biotechnology, LLC
Document Number: 2019-06854
Type: Notice
Date: 2019-04-08
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA in Schedule I
Document Number: 2019-06853
Type: Proposed Rule
Date: 2019-04-08
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing methyl 2- (1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbu tanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole-3- carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5- fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1- amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-ind azole-3- carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1H-indole-3- carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3- dimethylbutanoate [MDMB-FUBINACA], including their 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 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA.
Importer of Controlled Substances Application: SpecGx LLC
Document Number: 2019-06852
Type: Notice
Date: 2019-04-08
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Extension of Temporary Placement of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA in Schedule I of the Controlled Substances Act
Document Number: 2019-06851
Type: Rule
Date: 2019-04-08
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 six synthetic cannabinoids (SC). The substances are: methyl 2-(1-(5-fluoropentyl)-1H-indazole-3- carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2- (1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutano ate [5F- AMB]; N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxami de [5F-APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4- fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1- (cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutan oate [MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1H- indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA], including their optical, positional and geometric isomers, salts, and salts of isomers. The schedule I status of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA will expire on April 10, 2019. This temporary order will extend the temporary scheduling of 5F- ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA for one year or until the permanent scheduling action for these six substances is completed, whichever occurs first.
Importer of Controlled Substances Application: Unither Manufacturing LLC
Document Number: 2019-06850
Type: Notice
Date: 2019-04-08
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Organic Standards Solutions International, LLC
Document Number: 2019-06849
Type: Notice
Date: 2019-04-08
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2019-06848
Type: Notice
Date: 2019-04-08
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has submitted an application for registration to the Drug Enforcement Administration (DEA) to become a bulk manufacturer of various classes of schedule I controlled substances.
Importer of Controlled Substances Registration
Document Number: 2019-06847
Type: Notice
Date: 2019-04-08
Agency: Drug Enforcement Administration, Department of Justice
The applicant listed below has submitted an application for registration to the Drug Enforcement Administration (DEA) to become an importer of schedule I controlled substances.
Bulk Manufacturer of Controlled Substances Application: Synthcon, LLC
Document Number: 2019-06846
Type: Notice
Date: 2019-04-08
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2019-06845
Type: Notice
Date: 2019-04-08
Agency: Drug Enforcement Administration, Department of Justice
The applicant listed below has submitted an application for registration to the Drug Enforcement Administration (DEA) to become an importer of a schedule I controlled substance.
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2019-06844
Type: Notice
Date: 2019-04-08
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of schedule II controlled substances.
Importer of Controlled Substances Registration
Document Number: 2019-06843
Type: Notice
Date: 2019-04-08
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has applied for and been granted a registration by the Drug Enforcement Administration (DEA) as an importer of schedule II controlled substances.
Importer of Controlled Substances Registration
Document Number: 2019-06842
Type: Notice
Date: 2019-04-08
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 or schedule II controlled substances.
Martin A. Barrios, M.D.; Decision and Order
Document Number: 2019-06836
Type: Notice
Date: 2019-04-08
Agency: Drug Enforcement Administration, Department of Justice
Richard Carter, M.D.; Decision and Order
Document Number: 2019-06835
Type: Notice
Date: 2019-04-08
Agency: Drug Enforcement Administration, Department of Justice
Craig M. Weingrow, M.D.; Decision and Order
Document Number: 2019-06834
Type: Notice
Date: 2019-04-08
Agency: Drug Enforcement Administration, Department of Justice