Drug Enforcement Administration 2015 – Federal Register Recent Federal Regulation Documents

Importer of Controlled Substances Application: Johnson Matthey, Inc.
Document Number: 2015-32640
Type: Notice
Date: 2015-12-29
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration: Alltech Associates, Inc.
Document Number: 2015-32370
Type: Notice
Date: 2015-12-24
Agency: Drug Enforcement Administration, Department of Justice
Alltech Associates, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Alltech Associates, Inc. registration as an importer of those controlled substances.
Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI)
Document Number: 2015-32367
Type: Notice
Date: 2015-12-24
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Eluxadoline Into Schedule IV; Correction
Document Number: 2015-31843
Type: Rule
Date: 2015-12-17
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is correcting a final rule that appeared in the Federal Register of November 12, 2015 (80 FR 69861). The document issued an action placing the substance 5- [[[(2S)-2-amino-3-[4-aminocarbonyl)-2,6-dimethylphenyl]-1- oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]meth yl]-2- methoxybenzoic acid (eluxadoline), including its salts, isomers, and salts of isomers, into schedule IV of the Controlled Substances Act. This document inadvertently included a paragraph in the regulatory text that was not intended for publication, and was unable to be removed before being placed on public inspection. This document corrects the final rule by removing this paragraph.
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2015-31672
Type: Notice
Date: 2015-12-17
Agency: Drug Enforcement Administration, Department of Justice
Manufacturer of Controlled Substances Registration: Austin Pharma LLC
Document Number: 2015-31667
Type: Notice
Date: 2015-12-17
Agency: Drug Enforcement Administration, Department of Justice
Austin Pharma LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Austin Pharma LLC registration as a manufacturer of those controlled substances.
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey, Inc.
Document Number: 2015-31665
Type: Notice
Date: 2015-12-17
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cody Laboratories, Inc.
Document Number: 2015-31074
Type: Notice
Date: 2015-12-10
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc.
Document Number: 2015-31073
Type: Notice
Date: 2015-12-10
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration: Cody Laboratories, Inc.
Document Number: 2015-30814
Type: Notice
Date: 2015-12-08
Agency: Drug Enforcement Administration, Department of Justice
Cody Laboratories, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cody Laboratories, Inc. registration as an importer of those controlled substances.
Importer of Controlled Substances Registration: Cambrex Charles City
Document Number: 2015-30813
Type: Notice
Date: 2015-12-08
Agency: Drug Enforcement Administration, Department of Justice
Cambrex Charles City applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cambrex Charles City registration as an importer of those controlled substances.
Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc.
Document Number: 2015-30812
Type: Notice
Date: 2015-12-08
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Pharmaceutical Materials, Inc.
Document Number: 2015-30811
Type: Notice
Date: 2015-12-08
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration: Akorn, Inc.
Document Number: 2015-30559
Type: Notice
Date: 2015-12-03
Agency: Drug Enforcement Administration, Department of Justice
Akorn, Inc. applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Akorn, Inc. registration as an importer of this controlled substance.
Manufacturer of Controlled Substances Registration: Navinta, LLC
Document Number: 2015-30558
Type: Notice
Date: 2015-12-03
Agency: Drug Enforcement Administration, Department of Justice
Navinta, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Navinta, LLC registration as a manufacturer of those controlled substances.
Importer of Controlled Substances Registration: Fresenius Kabi USA, LLC
Document Number: 2015-30556
Type: Notice
Date: 2015-12-03
Agency: Drug Enforcement Administration, Department of Justice
Fresenius Kabi USA, LLC applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Fresenius Kabi USA, LLC registration as an importer of this controlled substance.
Importer of Controlled Substances Application: Mylan Technologies, Inc.
Document Number: 2015-30555
Type: Notice
Date: 2015-12-03
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Organix, Inc.
Document Number: 2015-30554
Type: Notice
Date: 2015-12-03
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Meridian Medical Technologies
Document Number: 2015-30553
Type: Notice
Date: 2015-12-03
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration: United States Pharmacopeial Convention
Document Number: 2015-30552
Type: Notice
Date: 2015-12-03
Agency: Drug Enforcement Administration, Department of Justice
United States Pharmacopeial Convention applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants United States Pharmacopeial Convention registration as an importer of those controlled substances.
Importer of Controlled Substances Registration: Catalent CTS, LLC
Document Number: 2015-30551
Type: Notice
Date: 2015-12-03
Agency: Drug Enforcement Administration, Department of Justice
Catalent CTS, LLC applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Catalent CTS, LLC registration as an importer of this controlled substance.
Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.
Document Number: 2015-30550
Type: Notice
Date: 2015-12-03
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc.
Document Number: 2015-30549
Type: Notice
Date: 2015-12-03
Agency: Drug Enforcement Administration, Department of Justice
Daniel A. Glick, D.D.S.; Decision and Order
Document Number: 2015-30256
Type: Notice
Date: 2015-11-30
Agency: Drug Enforcement Administration, Department of Justice
William Mikaitis, M.D.; Decision and Order
Document Number: 2015-29935
Type: Notice
Date: 2015-11-25
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: VHG Labs DBA LGC Standards Warehouse
Document Number: 2015-29934
Type: Notice
Date: 2015-11-25
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Eluxadoline Into Schedule IV
Document Number: C1-2015-28718
Type: Rule
Date: 2015-11-16
Agency: Drug Enforcement Administration, Department of Justice
Mark William Andrew Holder, M.D.; Decision and Order
Document Number: 2015-28928
Type: Notice
Date: 2015-11-16
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Extension of Temporary Placement of Three Synthetic Phenethylamines in Schedule I
Document Number: 2015-29028
Type: Rule
Date: 2015-11-13
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this final order extending the temporary schedule I status for three synthetic phenethylamines into the Controlled Substances Act pursuant to the temporary scheduling provisions of the Act. The substances are: 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) [hereinafter 25I-NBOMe, 2C-NBOMe, and 25-NBOMe, respectively]. The initial temporary scheduling was based on a finding by the Deputy Administrator that the placement of these synthetic phenethylamines and their optical, positional, and geometric isomers, salts, and salts of isomers into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. The current final order temporarily placing 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe in schedule I is due to expire on November 14, 2015. This final order will extend the temporary scheduling of 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe for one year, or until the permanent scheduling action for these three substances is completed, whichever occurs first. As a result of this order, the full effect of the Controlled Substances Act and its implementing regulations, including criminal, civil and administrative penalties, sanctions, and regulatory controls of schedule I substances will be imposed on the manufacture, distribution, possession, importation, and exportation of these synthetic phenethylamines.
Schedules of Controlled Substances: Placement of Three Synthetic Phenethylamines Into Schedule I
Document Number: 2015-29026
Type: Proposed Rule
Date: 2015-11-13
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing 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) into schedule I of the Controlled Substances Act. This proposed scheduling action is pursuant to the Controlled Substance Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. If finalized, this action would 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, conduct instructional activities or chemical analysis, or possess), or propose to handle 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe.
Christina B. Paylan, M.D.; Decision and Order
Document Number: 2015-28727
Type: Notice
Date: 2015-11-12
Agency: Drug Enforcement Administration, Department of Justice
Perry County Food & Drug Decision and Order
Document Number: 2015-28723
Type: Notice
Date: 2015-11-12
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Eluxadoline Into Schedule IV
Document Number: 2015-28718
Type: Rule
Date: 2015-11-12
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Administrator of the Drug Enforcement Administration places the substance 5-[[[(2S)-2-amino- 3-[4-aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-( 4-phenyl- 1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid (eluxadoline), including its salts, isomers, and salts of isomers, into schedule IV 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 IV controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities, or possess) or propose to handle eluxadoline.
Schedules of Controlled Substances: Table of Excluded Nonnarcotic Products: Vicks® VapoInhaler®
Document Number: 2015-27266
Type: Rule
Date: 2015-10-27
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is amending the table of Excluded Nonnarcotic Products to update the listing for Vicks[supreg] VapoInhaler[supreg], containing 50 mg levmetamfetamine in a nasal decongestant inhaler, marketed by The Proctor & Gamble Company. This over-the-counter, non-narcotic drug product is excluded from provisions of the Controlled Substances Act.
Schedules of Controlled Substances: Table of Excluded Nonnarcotic Products: Nasal Decongestant Inhaler/Vapor Inhaler
Document Number: 2015-27264
Type: Rule
Date: 2015-10-27
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is amending the table of Excluded Nonnarcotic Products to update the company name for the drug product Nasal Decongestant Inhaler/Vapor Inhaler (containing 50 milligrams levmetamfetamine) to Aphena Pharma SolutionsNew York, LLC. This over-the-counter, nonnarcotic drug product is excluded from the provisions of the Controlled Substances Act.
Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc.
Document Number: 2015-26682
Type: Notice
Date: 2015-10-21
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, Inc.
Document Number: 2015-26675
Type: Notice
Date: 2015-10-21
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2015-26674
Type: Notice
Date: 2015-10-21
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cody Laboratories, Inc.
Document Number: 2015-26670
Type: Notice
Date: 2015-10-21
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City
Document Number: 2015-26669
Type: Notice
Date: 2015-10-21
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Sigma-Aldrich International GMBH-Sigma Aldrich Co LLC
Document Number: 2015-26668
Type: Notice
Date: 2015-10-21
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chemicals, Inc.
Document Number: 2015-25882
Type: Notice
Date: 2015-10-13
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration: Unither Manufacturing, LLC
Document Number: 2015-25881
Type: Notice
Date: 2015-10-13
Agency: Drug Enforcement Administration, Department of Justice
Unither Manufacturing, LLC applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Unither Manufacturing, LLC registration as an importer of this controlled substance.
Bulk Manufacturer of Controlled Substances Application: Apertus Pharmaceuticals
Document Number: 2015-25880
Type: Notice
Date: 2015-10-13
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cambridge Isotope Lab
Document Number: 2015-25879
Type: Notice
Date: 2015-10-13
Agency: Drug Enforcement Administration, Department of Justice
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 2016
Document Number: 2015-25373
Type: Notice
Date: 2015-10-06
Agency: Drug Enforcement Administration, Department of Justice
This final order establishes the initial 2016 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 Application: Cerilliant Corporation
Document Number: 2015-24748
Type: Notice
Date: 2015-09-30
Agency: Drug Enforcement Administration, Department of Justice
Manufacturer of Controlled Substances Registration: Noramco, Inc.
Document Number: 2015-24747
Type: Notice
Date: 2015-09-30
Agency: Drug Enforcement Administration, Department of Justice
Noramco, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Noramco, Inc. registration as a manufacturer of those controlled substances.
James Alvin Chaney, M.D.: Decision and Order
Document Number: 2015-24128
Type: Notice
Date: 2015-09-23
Agency: Drug Enforcement Administration, Department of Justice