Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

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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
Steven W. Easley, M.D.; Decision and Order
Document Number: 2017-11796
Type: Notice
Date: 2017-06-07
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Acetyl Fentanyl Into Schedule I
Document Number: 2017-11795
Type: Rule
Date: 2017-06-07
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final order, the Administrator of the Drug Enforcement Administration will maintain the placement of the substance acetyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- phenylacetamide), including its isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act and is required in order for the United States to discharge its 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, acetyl fentanyl.
Schedules of Controlled Substances: Temporary Placement of Acryl Fentanyl Into Schedule I
Document Number: 2017-11215
Type: Proposed Rule
Date: 2017-06-02
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to issue a temporary order to schedule the synthetic opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide (acryl fentanyl or acryloylfentanyl), 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. 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 this synthetic opioid.
Importer of Controlled Substances Registration
Document Number: 2017-11388
Type: Notice
Date: 2017-06-01
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: Cerilliant Corporation
Document Number: 2017-11387
Type: Notice
Date: 2017-06-01
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Chemtos, LLC
Document Number: 2017-11385
Type: Notice
Date: 2017-06-01
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2017-11383
Type: Notice
Date: 2017-06-01
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.
Josip Pasic, M.D.; Order
Document Number: 2017-10742
Type: Notice
Date: 2017-05-25
Agency: Drug Enforcement Administration, Department of Justice
Shakeel A. Kahn, M.D.; Decision and Order
Document Number: 2017-10386
Type: Notice
Date: 2017-05-22
Agency: Drug Enforcement Administration, Department of Justice
Steven Bernhard, D.O.; Decision and Order
Document Number: 2017-10363
Type: Notice
Date: 2017-05-22
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Whatever LLC
Document Number: 2017-10243
Type: Notice
Date: 2017-05-19
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mallinckrodt LLC
Document Number: 2017-10242
Type: Notice
Date: 2017-05-19
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories
Document Number: 2017-10241
Type: Notice
Date: 2017-05-19
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chemicals
Document Number: 2017-10240
Type: Notice
Date: 2017-05-19
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc.
Document Number: 2017-10238
Type: Notice
Date: 2017-05-19
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Galephar Pharmaceutical Research, Inc.
Document Number: 2017-10234
Type: Notice
Date: 2017-05-19
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Pharmaceutical Materials, Inc.
Document Number: 2017-10233
Type: Notice
Date: 2017-05-19
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Chemtos, LLC
Document Number: 2017-10231
Type: Notice
Date: 2017-05-19
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing, LLC
Document Number: 2017-10230
Type: Notice
Date: 2017-05-19
Agency: Drug Enforcement Administration, Department of Justice
Roberto Zayas, M.D., Decision and Order
Document Number: 2017-09285
Type: Notice
Date: 2017-05-08
Agency: Drug Enforcement Administration, Department of Justice
Judson J. Somerville, M.D.; Decision and Order
Document Number: 2017-09284
Type: Notice
Date: 2017-05-08
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of 4-Fluoroisobutyryl Fentanyl into Schedule I
Document Number: 2017-08943
Type: Rule
Date: 2017-05-03
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-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide (4-fluoroisobutyryl fentanyl or para-fluoroisobutyryl 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 4-fluoroisobutyryl 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, 4- fluoroisobutyryl fentanyl.
David D. Moon, D.O.; Decision and Order
Document Number: 2017-08452
Type: Notice
Date: 2017-04-27
Agency: Drug Enforcement Administration, Department of Justice
Robert Clark Maiocco, M.D.; Decision and Order
Document Number: 2017-08450
Type: Notice
Date: 2017-04-27
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC
Document Number: 2017-08347
Type: Notice
Date: 2017-04-25
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cambridge Isotope Laboratories
Document Number: 2017-08346
Type: Notice
Date: 2017-04-25
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Janssen Ortho LLC
Document Number: 2017-08345
Type: Notice
Date: 2017-04-25
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Sigma Aldrich Research Biochemicals, Inc.
Document Number: 2017-08344
Type: Notice
Date: 2017-04-25
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals
Document Number: 2017-08343
Type: Notice
Date: 2017-04-25
Agency: Drug Enforcement Administration, Department of Justice
William H. Wyttenbach, M.D.; Decision and Order
Document Number: 2017-08013
Type: Notice
Date: 2017-04-21
Agency: Drug Enforcement Administration, Department of Justice
Richard Jay Blackburn, D.O.; Decision and Order
Document Number: 2017-08014
Type: Notice
Date: 2017-04-20
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: 2017-07118
Type: Rule
Date: 2017-04-10
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to 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], and their optical, positional, and geometric isomers, salts, and salts of isomers 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 these synthetic cannabinoids 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, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA or MDMB-FUBINACA.
Importer of Controlled Substances Application: Xcelience
Document Number: 2017-06555
Type: Notice
Date: 2017-04-04
Agency: Drug Enforcement Administration, Department of Justice
Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension With or Without Change, of a Previously Approved Collection Drug Questionnaire (DEA-341)
Document Number: 2017-06079
Type: Notice
Date: 2017-03-28
Agency: Drug Enforcement Administration, Department of Justice
The Department of Justice (DOJ), Drug Enforcement Administration (DEA), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] in Schedule II
Document Number: 2017-05809
Type: Rule
Date: 2017-03-23
Agency: Drug Enforcement Administration, Department of Justice
On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] oral solution. Thereafter, the Department of Health and Human Services (HHS) provided the Drug Enforcement Administration (DEA) with a scheduling recommendation that would result in Syndros (and other oral solutions containing dronabinol) being placed in schedule II 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 FDA-approved products of oral solutions containing dronabinol in schedule II of the CSA.
Importer of Controlled Substances Registration
Document Number: 2017-05730
Type: Notice
Date: 2017-03-23
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: 2017-05729
Type: Notice
Date: 2017-03-23
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of 4-Fluoroisobutyryl Fentanyl Into Schedule I
Document Number: 2017-05728
Type: Proposed Rule
Date: 2017-03-23
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to issue a temporary order to schedule the synthetic opioid, N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4- yl)isobutyramide (4-fluoroisobutyryl fentanyl or para-fluoroisobutyryl 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. 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 this synthetic opioid.
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2017-05727
Type: Notice
Date: 2017-03-23
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.
Wesley Pope, M.D.; Decision and Order
Document Number: 2017-05676
Type: Notice
Date: 2017-03-23
Agency: Drug Enforcement Administration, Department of Justice
Program To Hire Special Assistant United States Attorneys in Targeted Federal Judicial Districts Utilizing Diversion Control Fee Account Funds
Document Number: 2017-05396
Type: Proposed Rule
Date: 2017-03-21
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is proposing a rule that would expand and enhance the enforcement component of the Diversion Control Program (DCP) as previously outlined in the December 30, 1996, Federal Register document ``Registration and Reregistration Application Fees,'' hereinafter referred to as the 1996 Rule. The 1996 Rule specified six types of investigations involving the diversion of controlled substances, which could be pursued by the DCP utilizing funding from the Diversion Control Fee Account (DCFA). Those investigations included the theft or robbery of pharmaceutical controlled substances, the acquisition of pharmaceutical controlled substances through fraud or deceit, and other illegal diversion activities. The 1996 Rule also authorized the continued use and expansion by the DCP of Tactical Diversion Squads (TDSs), defined as, ``enforcement teams consisting of Federal, state, and local law enforcement personnel fully dedicated to the investigation and prosecution of persons involved in the diversion of controlled substances.''
Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics, Inc.
Document Number: 2017-04875
Type: Notice
Date: 2017-03-13
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Brivaracetam Into Schedule V
Document Number: 2017-04698
Type: Rule
Date: 2017-03-09
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 May 12, 2016. The Drug Enforcement Administration is placing the substance brivaracetam ((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide) (also referred to as BRV; UCB-34714; Briviact) (including its salts) into schedule V of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act, as revised by the Improving Regulatory Transparency for New Medical Therapies Act which was signed into law on November 25, 2015.
Importer of Controlled Substances Application: Meda Pharmaceuticals, Inc.
Document Number: 2017-04648
Type: Notice
Date: 2017-03-09
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Meridian Medical Technologies
Document Number: 2017-04647
Type: Notice
Date: 2017-03-09
Agency: Drug Enforcement Administration, Department of Justice