Drug Enforcement Administration 2018 – Federal Register Recent Federal Regulation Documents

Schedules of Controlled Substances: Temporary Placement of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 in Schedule I
Document Number: 2018-28110
Type: Proposed Rule
Date: 2018-12-28
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 cannabinoids (SCs), ethyl 2-(1-(5- fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoat e (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 name: FUB-AKB48; FUB-APINACA; AKB48 N-(4-FLUOROBENZYL)); 1-(5- fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxami de (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), 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 (CSA) is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose regulatory requirements under the CSA on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of these SCs, 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.
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 2019
Document Number: 2018-28108
Type: Notice
Date: 2018-12-28
Agency: Drug Enforcement Administration, Department of Justice
This final order establishes the initial 2019 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.
Importer of Controlled Substances Application: Myoderm
Document Number: 2018-28081
Type: Notice
Date: 2018-12-27
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Agilent Technologies
Document Number: 2018-28080
Type: Notice
Date: 2018-12-27
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2018-28078
Type: Notice
Date: 2018-12-27
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has applied for and been granted registration by the Drug Enforcement Administration (DEA) as an importer of various classes of schedule I or II controlled substances.
Importer of Controlled Substances Registration
Document Number: 2018-28076
Type: Notice
Date: 2018-12-27
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has applied for and been granted registration by the Drug Enforcement Administration (DEA) as an importer of schedule I or schedule II controlled substances.
Importer of Controlled Substances Application: Johnson Matthey Inc.
Document Number: 2018-28073
Type: Notice
Date: 2018-12-27
Agency: Drug Enforcement Administration, Department of Justice
Stephen R. Kovacs, D.O.; Decision and Order
Document Number: 2018-28072
Type: Notice
Date: 2018-12-27
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Usona Institute
Document Number: 2018-27133
Type: Notice
Date: 2018-12-14
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Usona Institute
Document Number: 2018-27132
Type: Notice
Date: 2018-12-14
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Arizona Department of Corrections
Document Number: 2018-27131
Type: Notice
Date: 2018-12-14
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cambrex High Point, Inc.
Document Number: 2018-27039
Type: Notice
Date: 2018-12-13
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Noramco Inc.
Document Number: 2018-27037
Type: Notice
Date: 2018-12-13
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc.
Document Number: 2018-27036
Type: Notice
Date: 2018-12-13
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mylan Technologies, Inc.
Document Number: 2018-27034
Type: Notice
Date: 2018-12-13
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Siegfried USA, LLC
Document Number: 2018-27032
Type: Notice
Date: 2018-12-13
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories
Document Number: 2018-27029
Type: Notice
Date: 2018-12-13
Agency: Drug Enforcement Administration, Department of Justice
Final Adjusted 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 2018
Document Number: 2018-26587
Type: Notice
Date: 2018-12-10
Agency: Drug Enforcement Administration, Department of Justice
This final order establishes the final adjusted 2018 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2018-26509
Type: Notice
Date: 2018-12-06
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 a schedule I controlled substance.
Decision and Order: Zelideh I. Cordova-Velazco, M.D.
Document Number: 2018-26485
Type: Notice
Date: 2018-12-06
Agency: Drug Enforcement Administration, Department of Justice
Exempt Chemical Preparations Under the Controlled Substances Act
Document Number: 2018-26067
Type: Notice
Date: 2018-12-03
Agency: Drug Enforcement Administration, Department of Justice
The applications for exempt chemical preparations received by the Drug Enforcement Administration (DEA) between January 1, 2017, and June 30, 2018, as listed below, were accepted for filing and have been approved or denied as indicated.
Narciso A. Reyes, M.D.; Decision and Order
Document Number: 2018-26047
Type: Notice
Date: 2018-11-30
Agency: Drug Enforcement Administration, Department of Justice
Steve Fanto, M.D.; Decision and Order
Document Number: 2018-26046
Type: Notice
Date: 2018-11-30
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Furanyl Fentanyl, 4-Fluoroisobutyryl Fentanyl, Acryl Fentanyl, Tetrahydrofuranyl Fentanyl, and Ocfentanil in Schedule I
Document Number: 2018-26045
Type: Rule
Date: 2018-11-29
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final order, the Acting Administrator of the Drug Enforcement Administration maintains the placement of the substances furanyl fentanyl [N-(1-phenethylpiperidin- 4-yl)-N-phenylfuran-2-carboxamide], 4-fluoroisobutyryl fentanyl or para-fluoroisobutyryl fentanyl [N-(4-fluorophenyl)-N-(1- phenethylpiperidin-4-yl)isobutyramide], acryl fentanyl or acryloylfentanyl [N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide], tetrahydrofuranyl fentanyl [N-(1-phenethylpiperidin-4-yl)-N- phenyltetrahydrofuran-2-carboxamide], and ocfentanil [N-(2- fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4-yl)acetamid e], including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, 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 continues to impose 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, furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil.
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2018-25875
Type: Notice
Date: 2018-11-27
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk a manufacturer of various classes of schedule I and II controlled substances.
Bulk Manufacturer of Controlled Substances Application: Noramco Inc.
Document Number: 2018-25874
Type: Notice
Date: 2018-11-27
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Akorn, Inc.
Document Number: 2018-25873
Type: Notice
Date: 2018-11-27
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2018-25872
Type: Notice
Date: 2018-11-27
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cambridge Isotope Laboratories
Document Number: 2018-25869
Type: Notice
Date: 2018-11-27
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Sigma Aldrich Co., LLC
Document Number: 2018-25867
Type: Notice
Date: 2018-11-27
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2018-25866
Type: Notice
Date: 2018-11-27
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has applied for and been granted registration by the Drug Enforcement Administration (DEA) as an importer of various classes of schedule I or II controlled substances.
Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company
Document Number: 2018-25865
Type: Notice
Date: 2018-11-27
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: GE Healthcare
Document Number: 2018-25864
Type: Notice
Date: 2018-11-27
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2018-25863
Type: Notice
Date: 2018-11-27
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has applied for and has been granted registration by the Drug Enforcement Administration (DEA) as an importer of schedule I or II controlled substances.
Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing, LLC
Document Number: 2018-25862
Type: Notice
Date: 2018-11-27
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals
Document Number: 2018-24485
Type: Notice
Date: 2018-11-09
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2018-24484
Type: Notice
Date: 2018-11-09
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has applied for and been granted 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: Janssen Pharmaceuticals, Inc.
Document Number: 2018-24006
Type: Notice
Date: 2018-11-02
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2018-24005
Type: Notice
Date: 2018-11-02
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 various classes of schedule I and II controlled substances.
Eric Lee Knight, M.D.; Decision and Order
Document Number: 2018-23708
Type: Notice
Date: 2018-10-30
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Sharp (Bethlehem), LLC
Document Number: 2018-23705
Type: Notice
Date: 2018-10-30
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2018-23702
Type: Notice
Date: 2018-10-30
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: United States Pharmacopeial Convention
Document Number: 2018-23701
Type: Notice
Date: 2018-10-30
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cambrex High Point, Inc.
Document Number: 2018-23699
Type: Notice
Date: 2018-10-30
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2018-23698
Type: Notice
Date: 2018-10-30
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 various classes of schedule I and II controlled substances.
Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing, LLC
Document Number: 2018-23696
Type: Notice
Date: 2018-10-30
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Sigma Aldrich Research
Document Number: 2018-23695
Type: Notice
Date: 2018-10-30
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Catalent CTS, LLC
Document Number: 2018-23686
Type: Notice
Date: 2018-10-30
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2018-23684
Type: Notice
Date: 2018-10-30
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has applied for and been granted registration by the Drug Enforcement Administration (DEA) as an importer of schedule I or schedule II controlled substances.
Hisham M. Shawish, M.D.; Decision and Order
Document Number: 2018-23273
Type: Notice
Date: 2018-10-25
Agency: Drug Enforcement Administration, Department of Justice