Drug Enforcement Administration 2017 – Federal Register Recent Federal Regulation Documents

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Importer of Controlled Substances Application: Specgx LLC
Document Number: 2017-19784
Type: Notice
Date: 2017-09-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2017-19067
Type: Notice
Date: 2017-09-15
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of Ortho-Fluorofentanyl, Tetrahydrofuranyl Fentanyl, and Methoxyacetyl Fentanyl Into Schedule I
Document Number: 2017-19283
Type: Proposed Rule
Date: 2017-09-12
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule the synthetic opioids, N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4- yl)propionamide (ortho-fluorofentanyl or 2-fluorofentanyl), N-(1- phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamid e (tetrahydrofuranyl fentanyl), and 2-methoxy-N-(1-phenethylpiperidin-4- yl)-N-phenylacetamide (methoxyacetyl fentanyl), into Schedule I. This action is based on a finding by the Administrator that the placement of these synthetic opioids into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to Schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of these synthetic opioids.
Schedules of Controlled Substances: Temporary Placement of FUB-AMB Into Schedule I
Document Number: 2017-17639
Type: Proposed Rule
Date: 2017-09-11
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule the synthetic cannabinoid, Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3- carboxamido)-3-methylbutanoate [FUB-AMB, MMB-FUBINACA, AMB-FUBINACA], into Schedule I. This action is based on a finding by the Administrator that the placement of this synthetic cannabinoid into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to Schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, possession, importation, exportation of, and research and conduct with, instructional activities of this synthetic cannabinoid.
Importer of Controlled Substances Application: Akorn, Inc.
Document Number: 2017-18803
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Siegfried USA, LLC
Document Number: 2017-18802
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc.
Document Number: 2017-18801
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Stepan Company
Document Number: 2017-18789
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Spex Certiprep Group, LLC
Document Number: 2017-18788
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: KVK-Tech, Inc.
Document Number: 2017-18787
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2017-18785
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Marcus W. Anderson, M.D.; Decision and Order
Document Number: 2017-18784
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cody Laboratories, Inc.
Document Number: 2017-18316
Type: Notice
Date: 2017-08-29
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.
Document Number: 2017-18315
Type: Notice
Date: 2017-08-29
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cambrex Charles City
Document Number: 2017-18314
Type: Notice
Date: 2017-08-29
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Stepan Company
Document Number: 2017-18313
Type: Notice
Date: 2017-08-29
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Fresenius Kabi USA, LLC
Document Number: 2017-18312
Type: Notice
Date: 2017-08-29
Agency: Drug Enforcement Administration, Department of Justice
Binh M. Chung, M.D.; Decision and Order
Document Number: 2017-18081
Type: Notice
Date: 2017-08-25
Agency: Drug Enforcement Administration, Department of Justice
Arnold E. Feldman, M.D.; Decision and Order
Document Number: 2017-17640
Type: Notice
Date: 2017-08-21
Agency: Drug Enforcement Administration, Department of Justice
Masters Pharmaceutical, Inc.; Order
Document Number: 2017-17638
Type: Notice
Date: 2017-08-21
Agency: Drug Enforcement Administration, Department of Justice
Raman I. Popli, M.D.; Decision and Order
Document Number: 2017-17146
Type: Notice
Date: 2017-08-15
Agency: Drug Enforcement Administration, Department of Justice
Luis C B Gomez, D.D.S. Decision and Order
Document Number: 2017-17011
Type: Notice
Date: 2017-08-11
Agency: Drug Enforcement Administration, Department of Justice
Leia A. Frickey, M.D.; Decision and Order
Document Number: 2017-16700
Type: Notice
Date: 2017-08-08
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI)
Document Number: 2017-16699
Type: Notice
Date: 2017-08-08
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2017-16698
Type: Notice
Date: 2017-08-08
Agency: Drug Enforcement Administration, Department of Justice
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of various classes of schedule I or II controlled substances.
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 2018
Document Number: 2017-16439
Type: Notice
Date: 2017-08-07
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes to establish the 2018 aggregate production quotas for 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.
John D. Bray-Morris, M.D.; Decision and Order
Document Number: 2017-16446
Type: Notice
Date: 2017-08-04
Agency: Drug Enforcement Administration, Department of Justice
Marcia L. Sills, M.D.; Decision and Order
Document Number: 2017-16442
Type: Notice
Date: 2017-08-04
Agency: Drug Enforcement Administration, Department of Justice
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 2017
Document Number: 2017-16440
Type: Notice
Date: 2017-08-04
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes to adjust the 2017 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.
Importer of Controlled Substances Application: Cambrex High Point, Inc.
Document Number: 2017-16058
Type: Notice
Date: 2017-08-02
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: R & D Systems, Inc.
Document Number: 2017-16064
Type: Notice
Date: 2017-07-31
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Isosciences, LLC
Document Number: 2017-16060
Type: Notice
Date: 2017-07-31
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Sigma-Aldrich International GMBH
Document Number: 2017-16059
Type: Notice
Date: 2017-07-31
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: United States Pharmacopeial Convention
Document Number: 2017-15693
Type: Notice
Date: 2017-07-26
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2017-15692
Type: Notice
Date: 2017-07-26
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 controlled substances.
Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company
Document Number: 2017-15691
Type: Notice
Date: 2017-07-26
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Organic Consultants, Inc.
Document Number: 2017-15690
Type: Notice
Date: 2017-07-26
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: AMRI Rensselaer, Inc.
Document Number: 2017-15689
Type: Notice
Date: 2017-07-26
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc.
Document Number: 2017-15688
Type: Notice
Date: 2017-07-26
Agency: Drug Enforcement Administration, Department of Justice
Mohammed S. Aljanaby, M.D.; Decision and Order
Document Number: 2017-15494
Type: Notice
Date: 2017-07-25
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of Acryl Fentanyl Into Schedule I
Document Number: 2017-14880
Type: Rule
Date: 2017-07-14
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide (acryl fentanyl or acryloylfentanyl), and its isomers, esters, ethers, salts and salts of isomers, esters, and ethers, into Schedule I. This action is based on a finding by the Administrator that the placement of acryl fentanyl into 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, acryl fentanyl.
Designation of Alpha-Phenylacetoacetonitrile (APAAN), a Precursor Chemical Used in the Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as a List I Chemical
Document Number: 2017-14878
Type: Rule
Date: 2017-07-14
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is finalizing the designation of the chemical alpha-phenylacetoacetonitrile (APAAN) and its salts, optical isomers, and salts of optical isomers, as a list I chemical under the Controlled Substances Act (CSA). The DEA proposed control of APAAN, due to its use in clandestine laboratories to illicitly manufacture the schedule II controlled substances phenylacetone (also known as phenyl-2-propanone or P2P), methamphetamine, and amphetamine. This rulemaking finalizes, without change, the control of APAAN as a list I chemical. This action does not establish a threshold for domestic and international transactions of APAAN. As such, all transactions involving APAAN, regardless of size, shall be regulated. In addition, chemical mixtures containing APAAN are not exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical mixtures containing any quantity of APAAN shall be regulated pursuant to the CSA. However, manufacturers may submit an application for exemption for those mixtures that do not qualify for automatic exemption.
Sassan Bassiri, D.D.S.; Decision and Order
Document Number: 2017-14597
Type: Notice
Date: 2017-07-12
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Removal of Naldemedine From Control
Document Number: 2017-14482
Type: Proposed Rule
Date: 2017-07-12
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes to remove naldemedine (4R,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,7,9-trihydroxy- N-(2-(3-phenyl-1,2,4-oxadiazol-5-yl)propan-2-yl)-2,3,4,4a,5,7 a- hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-6-carbo xamide) including its salts from the schedules of the Controlled Substances Act (CSA). This action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. Naldemedine is currently a schedule II controlled substance because it can be derived from opium alkaloids. This action would remove the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle naldemedine.
Phong Tran, M.D.; Decision and Order
Document Number: 2017-14070
Type: Notice
Date: 2017-07-05
Agency: Drug Enforcement Administration, Department of Justice
John Warren Cox, M.D.; Decision and Order
Document Number: 2017-13527
Type: Notice
Date: 2017-06-28
Agency: Drug Enforcement Administration, Department of Justice
Peter F. Kelly, D.P.M.; Decision and Order
Document Number: 2017-13158
Type: Notice
Date: 2017-06-23
Agency: Drug Enforcement Administration, Department of Justice
Exempt Chemical Preparations Under the Controlled Substances Act
Document Number: 2017-12110
Type: Notice
Date: 2017-06-12
Agency: Drug Enforcement Administration, Department of Justice
The applications for exempt chemical preparations received by the Drug Enforcement Administration (DEA) between April 1, 2016, and December 31, 2016, as listed below, were accepted for filing and have been approved or denied as indicated.
Patricia A. Newton, M.D.; Order
Document Number: 2017-11798
Type: Notice
Date: 2017-06-07
Agency: Drug Enforcement Administration, Department of Justice
Emmanuel O. Nwaokocha, M.D.; Decision and Order
Document Number: 2017-11797
Type: Notice
Date: 2017-06-07
Agency: Drug Enforcement Administration, Department of Justice