Drug Enforcement Administration 2016 – Federal Register Recent Federal Regulation Documents

Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System (ITDS); Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments
Document Number: 2016-28966
Type: Rule
Date: 2016-12-30
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is updating its regulations for the import and export of tableting and encapsulating machines, controlled substances, and listed chemicals, and its regulations relating to reports required for domestic transactions in listed chemicals, gamma-hydroxybutyric acid, and tableting and encapsulating machines. In accordance with Executive Order 13563, the Drug Enforcement Administration has reviewed its import and export regulations and reporting requirements for domestic transactions in listed chemicals (and gamma-hydroxybutyric acid) and tableting and encapsulating machines, and evaluated them for clarity, consistency, continued accuracy, and effectiveness. The amendments clarify certain policies and reflect current procedures and technological advancements. The amendments also allow for the implementation, as applicable to tableting and encapsulating machines, controlled substances, and listed chemicals, of the President's Executive Order 13659 on streamlining the export/import process and requiring the government-wide utilization of the International Trade Data System (ITDS). This rule additionally contains amendments that implement recent changes to the Controlled Substances Import and Export Act (CSIEA) for reexportation of controlled substances among members of the European Economic Area made by the Improving Regulatory Transparency for New Medical Therapies Act. The rule also includes additional substantive and technical and stylistic amendments.
Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceutical, Inc.
Document Number: 2016-31641
Type: Notice
Date: 2016-12-29
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company
Document Number: 2016-31285
Type: Notice
Date: 2016-12-28
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc.
Document Number: 2016-31284
Type: Notice
Date: 2016-12-28
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc.
Document Number: 2016-31283
Type: Notice
Date: 2016-12-28
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Navinta LLC
Document Number: 2016-31282
Type: Notice
Date: 2016-12-28
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Noramco, Inc.
Document Number: 2016-31281
Type: Notice
Date: 2016-12-28
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2016-31280
Type: Notice
Date: 2016-12-28
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: Synthcon, LLC
Document Number: 2016-31279
Type: Notice
Date: 2016-12-28
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2016-31273
Type: Notice
Date: 2016-12-28
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.
Importer of Controlled Substances Application: Wildlife Laboratories, Inc.
Document Number: 2016-31272
Type: Notice
Date: 2016-12-28
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of Six Synthetic Cannabinoids (5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA) Into Schedule I
Document Number: 2016-30595
Type: Rule
Date: 2016-12-21
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to temporarily schedule six synthetic cannabinoids: 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-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-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], into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act (CSA). This action is based on a finding by the Administrator that the placement of these synthetic cannabinoids into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. Any final order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I substances under the Controlled Substances Act on the manufacture, distribution, possession, importation, exportation of, and research and conduct with, instructional activities of these synthetic cannabinoids.
Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute
Document Number: 2016-30368
Type: Notice
Date: 2016-12-19
Agency: Drug Enforcement Administration, Department of Justice
Establishment of a New Drug Code for Marihuana Extract
Document Number: 2016-29941
Type: Rule
Date: 2016-12-14
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is creating a new Administration Controlled Substances Code Number for ``Marihuana Extract.'' This code number will allow DEA and DEA-registered entities to track quantities of this material separately from quantities of marihuana. This, in turn, will aid in complying with relevant treaty provisions. Under international drug control treaties administered by the United Nations, some differences exist between the regulatory controls pertaining to marihuana extract versus those for marihuana and tetrahydrocannabinols. The DEA has previously established separate code numbers for marihuana and for tetrahydrocannabinols, but not for marihuana extract. To better track these materials and comply with treaty provisions, DEA is creating a separate code number for marihuana extract with the following definition: ``Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.'' Extracts of marihuana will continue to be treated as Schedule I controlled substances.
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: 2016-29523
Type: Proposed Rule
Date: 2016-12-12
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is proposing to designate 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. APAAN is used in clandestine laboratories to illicitly manufacture the schedule II controlled substances phenylacetone (also known as phenyl-2-propanone or P2P), methamphetamine, and amphetamine and is important to the manufacture of these controlled substances. This action does not propose the establishment of a threshold for domestic and international transactions of APAAN. As such, all transactions involving APAAN, regardless of size, would be regulated. In addition, this action proposes that chemical mixtures containing APAAN would not be exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical mixtures containing any quantity of APAAN would be regulated pursuant to the Controlled Substances Act.
Schedules of Controlled Substances: Temporary Placement of Furanyl Fentanyl Into Schedule I
Document Number: 2016-28693
Type: Rule
Date: 2016-11-29
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this final order to temporarily schedule the synthetic opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide (furanyl fentanyl), and its isomers, esters, ethers, salts and salts of isomers, esters and ethers, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of furanyl 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, furanyl fentanyl.
Schedules of Controlled Substances: Temporary Placement of U-47700 Into Schedule I
Document Number: 2016-27357
Type: Rule
Date: 2016-11-14
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this final order to temporarily schedule the synthetic opioid, 3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamid e (also known as U-47700), and its isomers, esters, ethers, salts and salts of isomers, esters and ethers, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of U-47700 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, U-47700.
Jones Total Health Care Pharmacy, L.L.C., and SND Health Care, L.L.C.; Decision and Order
Document Number: 2016-27120
Type: Notice
Date: 2016-11-10
Agency: Drug Enforcement Administration, Department of Justice
Waleed Khan, M.D.; Decision and Order
Document Number: 2016-27117
Type: Notice
Date: 2016-11-10
Agency: Drug Enforcement Administration, Department of Justice
Thomas Horiagon, M.D.; Decision and Order
Document Number: 2016-27116
Type: Notice
Date: 2016-11-10
Agency: Drug Enforcement Administration, Department of Justice
Edge Pharmacy; Decision and Order
Document Number: 2016-25226
Type: Notice
Date: 2016-10-19
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc.
Document Number: 2016-25133
Type: Notice
Date: 2016-10-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Anderson Brecon, Inc.
Document Number: 2016-25131
Type: Notice
Date: 2016-10-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Johnson Matthey Inc.
Document Number: 2016-25126
Type: Notice
Date: 2016-10-18
Agency: Drug Enforcement Administration, Department of Justice
Withdrawal of Notice of Intent to Temporarily Place Mitragynine and 7-Hydroxymitragynine Into Schedule I
Document Number: 2016-24659
Type: Proposed Rule
Date: 2016-10-13
Agency: Drug Enforcement Administration, Department of Justice
On August 31, 2016, the Drug Enforcement Administration (DEA) published in the Federal Register a notice of intent to temporarily place mitragynine and 7-hydroxymitragynine, which are the main psychoactive constituents of the plant Mitragyna speciosa, also referred to as kratom, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. Since publishing that notice, DEA has received numerous comments from members of the public challenging the scheduling action and requesting that the agency consider those comments and accompanying information before taking further action. In addition, DEA will receive from the Food and Drug Administration (FDA) a scientific and medical evaluation and scheduling recommendation for these substances, which DEA previously requested. DEA is therefore taking the following actions: DEA is withdrawing the August 31, 2016 notice of intent; and soliciting comments from the public regarding the scheduling of mitragynine and 7-hydroxymitragynine under the Controlled Substances Act.
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 2017
Document Number: 2016-23988
Type: Notice
Date: 2016-10-05
Agency: Drug Enforcement Administration, Department of Justice
This final order establishes the initial 2017 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.
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2016-23887
Type: Notice
Date: 2016-10-04
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Three Synthetic Phenethylamines Into Schedule I
Document Number: 2016-23185
Type: Rule
Date: 2016-09-27
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Administrator of the Drug Enforcement Administration places three synthetic phenethylamines: 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I- NBOMe; 2C-I-NBOMe; 25I; Cimbi-5), 2-(4-chloro-2,5-dimethoxyphenyl)-N- (2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82), and 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B- NBOMe; 2C-B-NBOMe; 25B; Cimbi-36), including their optical, positional, and geometric isomers, salts and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This action continues the application of 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 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe.
Schedules of Controlled Substances: Temporary Placement of Furanyl Fentanyl Into Schedule I
Document Number: 2016-23183
Type: Proposed Rule
Date: 2016-09-27
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to temporarily schedule the synthetic opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide (furanyl fentanyl), into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of this synthetic opioid into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. Any final 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, research, and conduct of, instructional activities of this synthetic opioid.
Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2016-23019
Type: Notice
Date: 2016-09-26
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Catalent CTS, LLC
Document Number: 2016-23017
Type: Notice
Date: 2016-09-26
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Nanosyn, Inc.
Document Number: 2016-22737
Type: Notice
Date: 2016-09-21
Agency: Drug Enforcement Administration, Department of Justice
Richard J. Settles, D.O.; Decision and Order
Document Number: 2016-22680
Type: Notice
Date: 2016-09-21
Agency: Drug Enforcement Administration, Department of Justice
Charles Szyman, D.O.; Decision and Order
Document Number: 2016-22677
Type: Notice
Date: 2016-09-21
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Euticals Inc.
Document Number: 2016-22527
Type: Notice
Date: 2016-09-20
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.
Document Number: 2016-22526
Type: Notice
Date: 2016-09-20
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: R & D Systems, Inc.
Document Number: 2016-22525
Type: Notice
Date: 2016-09-20
Agency: Drug Enforcement Administration, Department of Justice
Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System; Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments
Document Number: 2016-21589
Type: Proposed Rule
Date: 2016-09-15
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is proposing to update its regulations for the import and export of tableting and encapsulating machines, controlled substances, and listed chemicals, and its regulations relating to reports required for domestic transactions in listed chemicals, gamma-hydroxybutyric acid, and tableting and encapsulating machines. In accordance with Executive Order 13563, the Drug Enforcement Administration has reviewed its import and export regulations and reporting requirements for domestic transactions in listed chemicals (and gamma-hydroxybutyric acid) and tableting and encapsulating machines, and evaluated them for clarity, consistency, continued accuracy, and effectiveness. The proposed amendments clarify certain policies and reflect current procedures and technological advancements. The amendments also allow for the implementation, as applicable to tableting and encapsulating machines, controlled substances, and listed chemicals, of the President's Executive Order 13659 on streamlining the export/import process and requiring the government-wide utilization of the International Trade Data System. This proposal additionally contains amendments that would implement recent changes to the Controlled Substances Import and Export Act (CSIEA) for reexportation of controlled substances among members of the European Economic Area made by the Improving Regulatory Transparency for New Medical Therapies Act. The proposal includes additional substantive and technical amendments.
Bulk Manufacturer of Controlled Substances Application: Alcami Wisconsin Corporation
Document Number: 2016-22100
Type: Notice
Date: 2016-09-14
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2016-22083
Type: Notice
Date: 2016-09-14
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.
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2016-22082
Type: Notice
Date: 2016-09-14
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.
Importer of Controlled Substances Application: United States Pharmacopeial Convention
Document Number: 2016-22079
Type: Notice
Date: 2016-09-14
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals LLC
Document Number: 2016-22078
Type: Notice
Date: 2016-09-14
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cambrex Charles City
Document Number: 2016-22077
Type: Notice
Date: 2016-09-14
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Sigma-Aldrich International GMBH-Sigma Aldrich Company LLC
Document Number: 2016-22076
Type: Notice
Date: 2016-09-14
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing LLC
Document Number: 2016-22075
Type: Notice
Date: 2016-09-14
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, Inc.
Document Number: 2016-22074
Type: Notice
Date: 2016-09-14
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Chattem Chemicals, Inc.
Document Number: 2016-21536
Type: Notice
Date: 2016-09-08
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of U-47700 Into Schedule I
Document Number: 2016-21477
Type: Proposed Rule
Date: 2016-09-07
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to temporarily schedule the synthetic opioid, 3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamid e (also known as U-47700), into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of this synthetic opioid into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. Any final 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, research, and conduct of, instructional activities of this synthetic opioid.
Schedules of Controlled Substances: Placement of PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA into Schedule I
Document Number: 2016-21345
Type: Rule
Date: 2016-09-06
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Drug Enforcement Administration places quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC), quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3- carboxylate (5-fluoro-PB-22; 5F-PB-22), N-(1-amino-3-methyl-1-oxobutan- 2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) and N- (1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3 - carboxamide (ADB-PINACA), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This action imposes 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 PB-22, 5F-PB-22, AB- FUBINACA, or ADB-PINACA.