Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 3,690
Importer of Controlled Substances Application: Cambridge Isotope Laboratories
Document Number: 2020-19806
Type: Notice
Date: 2020-09-08
Agency: Drug Enforcement Administration, Department of Justice
Cambridge Isotope Laboratories has applied to be registered as an importer of basic class(es) of controlled substances. Refer to Supplemental Information listed below for further drugs information.
Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company
Document Number: 2020-19805
Type: Notice
Date: 2020-09-08
Agency: Drug Enforcement Administration, Department of Justice
Cayman Chemical Company has applied to be registered as a bulk manufacturer of basic class(es) controlled substances. Refer to Supplemental Information listed below for further drug information.
Importer of Controlled Substances Application: Aspen API, Inc.
Document Number: 2020-19804
Type: Notice
Date: 2020-09-08
Agency: Drug Enforcement Administration, Department of Justice
Aspen API, Inc. has applied to be registered as an importer of basic class(es) of controlled substance. Refer to Supplemental Information listed below for further drug information.
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 2020
Document Number: 2020-19308
Type: Notice
Date: 2020-09-01
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes to adjust the 2020 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
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 2021
Document Number: 2020-19285
Type: Notice
Date: 2020-09-01
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes to establish the 2021 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Heavenly Care Pharmacy; Decision and Order
Document Number: 2020-18975
Type: Notice
Date: 2020-08-28
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Extension of Temporary Placement of N-Ethylpentylone in Schedule I of the Controlled Substances Act
Document Number: 2020-19011
Type: Rule
Date: 2020-08-27
Agency: Drug Enforcement Administration, Department of Justice
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
Document Number: 2020-19007
Type: Proposed Rule
Date: 2020-08-27
Agency: Drug Enforcement Administration, Department of Justice
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
Document Number: 2020-17356
Type: Rule
Date: 2020-08-21
Agency: Drug Enforcement Administration, Department of Justice
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
Document Number: 2020-17951
Type: Rule
Date: 2020-08-20
Agency: Drug Enforcement Administration, Department of Justice
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
Document Number: 2020-17357
Type: Rule
Date: 2020-08-20
Agency: Drug Enforcement Administration, Department of Justice
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.
Morning Star Pharmacy & Medical Supply 1; Decision And Order
Document Number: 2020-18083
Type: Notice
Date: 2020-08-19
Agency: Drug Enforcement Administration, Department of Justice
David Mwebe, M.D.; Decision and Order
Document Number: 2020-18082
Type: Notice
Date: 2020-08-19
Agency: Drug Enforcement Administration, Department of Justice
Mark D. Beale, M.D.; Decision and Order
Document Number: 2020-17448
Type: Notice
Date: 2020-08-11
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Purisys, LLC
Document Number: 2020-17438
Type: Notice
Date: 2020-08-11
Agency: Drug Enforcement Administration, Department of Justice
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
Document Number: 2020-17437
Type: Notice
Date: 2020-08-11
Agency: Drug Enforcement Administration, Department of Justice
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.
Document Number: 2020-17436
Type: Notice
Date: 2020-08-11
Agency: Drug Enforcement Administration, Department of Justice
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
Document Number: 2020-17435
Type: Notice
Date: 2020-08-11
Agency: Drug Enforcement Administration, Department of Justice
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
Document Number: 2020-17434
Type: Notice
Date: 2020-08-11
Agency: Drug Enforcement Administration, Department of Justice
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
Document Number: 2020-17432
Type: Notice
Date: 2020-08-11
Agency: Drug Enforcement Administration, Department of Justice
Epic Pharma, LLC applied to be registered as an importer of the following basic class(es) of a controlled substance: Methadone.
Tommy L. Louisville, M.D.; Decision and Order
Document Number: 2020-17373
Type: Notice
Date: 2020-08-10
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chemicals, Inc
Document Number: 2020-16775
Type: Notice
Date: 2020-08-03
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Curium US LLC
Document Number: 2020-16774
Type: Notice
Date: 2020-08-03
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Chattem Chemicals Inc
Document Number: 2020-16773
Type: Notice
Date: 2020-08-03
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Euticals Inc.
Document Number: 2020-16401
Type: Notice
Date: 2020-07-29
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC
Document Number: 2020-16397
Type: Notice
Date: 2020-07-29
Agency: Drug Enforcement Administration, Department of Justice
Salvatore Cavaliere, D.O.; Decision and Order
Document Number: 2020-16388
Type: Notice
Date: 2020-07-29
Agency: Drug Enforcement Administration, Department of Justice
Kaniz F. Khan-Jaffery, M.D.; Decision and Order
Document Number: 2020-16387
Type: Notice
Date: 2020-07-29
Agency: Drug Enforcement Administration, Department of Justice
Hamada Makarita, D.D.S.; Denial of Application
Document Number: 2020-16355
Type: Notice
Date: 2020-07-29
Agency: Drug Enforcement Administration, Department of Justice
Reporting of Theft or Significant Loss of Controlled Substances
Document Number: 2020-15635
Type: Proposed Rule
Date: 2020-07-29
Agency: Drug Enforcement Administration, Department of Justice
This proposed rule would amend Drug Enforcement Administration (DEA) regulations regarding DEA Form 106, used by DEA registrants to report thefts or significant losses of controlled substances, to clarify that all such forms must be submitted electronically. In addition, the proposed rule would add new requirements for the form to be submitted accurately and within a 15-day time period. This proposed rule will not change the requirement that registrants notify the DEA Field Division Office in their area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft.
Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals Virginia, LLC
Document Number: R1-2020-16100
Type: Notice
Date: 2020-07-28
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Ampac Fine Chemicals LLC
Document Number: C1-2020-16104
Type: Notice
Date: 2020-07-28
Agency: Drug Enforcement Administration, Department of Justice
Frederick M. Silvers, M.D.; Decision and Order
Document Number: 2020-16343
Type: Notice
Date: 2020-07-28
Agency: Drug Enforcement Administration, Department of Justice
Frank Joseph Stirlacci, M.D.; Decision and Order
Document Number: 2020-16193
Type: Notice
Date: 2020-07-27
Agency: Drug Enforcement Administration, Department of Justice
Registration and Reregistration Fees for Controlled Substance and List I Chemical Registrants
Document Number: 2020-16169
Type: Rule
Date: 2020-07-24
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is adjusting the fee schedule for registration and reregistration fees necessary to recover the costs of its Diversion Control Program relating to the registration and control of the manufacture, distribution, dispensing, importation and exportation of controlled substances and list I chemicals as mandated by the Controlled Substances Act (CSA). This final rule adopts the notice of proposed rulemaking published on March 16, 2020, to change the fee schedule and codify existing practices of the issuance of refunds by DEA for applicant registration fees, without change.
Bulk Manufacturer of Controlled Substances Application: Ampac Fine Chemicals LLC
Document Number: 2020-16104-2
Type: Notice
Date: 2020-07-24
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Ampac Fine Chemicals LLC
Document Number: 2020-16104
Type: Notice
Date: 2020-07-24
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Arizona Department of Corrections
Document Number: 2020-16103
Type: Notice
Date: 2020-07-24
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: United States Pharmacopeial Convention
Document Number: 2020-15465
Type: Notice
Date: 2020-07-17
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cambrex Charles City
Document Number: 2020-15464
Type: Notice
Date: 2020-07-17
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Extension of Temporary Placement of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA in Schedule I of the Controlled Substances Act
Document Number: 2020-14902
Type: Rule
Date: 2020-07-13
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 naphthalen-1-yl 1-(5-fluoropentyl)-1H- indole-3-carboxylate (trivial names: NM2201; CBL2201), N-(1-amino-3- methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carb oxamide (trivial name: 5F-AB-PINACA), 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)- 1H-indazole-3-carboxamide (trivial names: 4-CN-CUMYL-BUTINACA; 4-cyano- CUMYL-BUTINACA; 4-CN-CUMYL-BINACA; CUMYL-4CN-BINACA, SGT-78), methyl 2- (1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutano ate (trivial names: MMB-CHMICA, AMB-CHMICA), and 1-(5-fluoropentyl)-N-(2- phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide (trivial name: 5F-CUMYL-P7AICA), including their optical, positional, and geometric isomers, salts, and salts of isomers. The schedule I status of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL- P7AICA currently is in effect until July 10, 2020. This temporary order will extend the temporary scheduling of NM2201, 5F-AB-PINACA, 4-CN- CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA for one year or until the permanent scheduling action for these substances is completed, whichever occurs first.
Schedules of Controlled Substances: Placement of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA in Schedule I
Document Number: 2020-14901
Type: Proposed Rule
Date: 2020-07-13
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes placing naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (trivial names: NM2201; CBL2201), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5- fluoropentyl)-1H-indazole-3-carboxamide (trivial name: 5F-AB-PINACA), 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carbox amide (trivial names: 4-CN-CUMYL-BUTINACA; 4-cyano-CUMYL-BUTINACA; 4-CN-CUMYL BINACA; CUMYL-4CN-BINACA, SGT-78), methyl 2-(1-(cyclohexylmethyl)-1H- indole-3-carboxamido)-3-methylbutanoate (trivial names: MMB-CHMICA, AMB-CHMICA), and 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H- pyrrolo[2,3-b]pyridine-3-carboxamide (trivial name: 5F-CUMYL-P7AICA), 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 with, or possess) or propose to handle NM2201, 5F-AB- PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA.
Bulk Manufacturer of Controlled Substances Application: Purisys, LLC
Document Number: 2020-14781
Type: Notice
Date: 2020-07-09
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Usona Institute
Document Number: 2020-14624
Type: Notice
Date: 2020-07-08
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Xcelience
Document Number: 2020-14623
Type: Notice
Date: 2020-07-08
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Galephar Pharmaceutical Research, Inc.
Document Number: 2020-14614
Type: Notice
Date: 2020-07-08
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Lipomed
Document Number: 2020-14605
Type: Notice
Date: 2020-07-07
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Organic Standards Solutions International, LLC
Document Number: 2020-13336
Type: Notice
Date: 2020-06-22
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of Isotonitazene in Schedule I
Document Number: 2020-12304
Type: Proposed Rule
Date: 2020-06-18
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 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 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 isotonitazene.