Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents
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Importer of Controlled Substances Registration: SA INTL GMBH C/O., Sigma Aldrich Co., LLC
SA INTL GMBH C/O., Sigma Aldrich Co., LLC, applied to be registered as an importer of certain basic classes of controlled substances. The DEA grants SA INTL GMBH C/O., Sigma Aldrich Co., LLC, registration as an importer of these controlled substances.
Manufacturer of Controlled Substances Registration: Patheon Pharmaceuticals, Inc.
Patheon Pharmaceuticals, Inc., applied to be registered as a manufacturer of a certain basic class of controlled substance. The DEA grants Patheon Pharmaceuticals, Inc., registration as a manufacturer of the controlled substance.
Manufacturer of Controlled Substances Registration: PCAS-Nanosyn, LLC
PCAS-Nanosyn, LLC applied to be registered as a manufacturer of certain basic classes of narcotic and non-narcotic controlled substances. The DEA grants PCAS-Nanosyn, LLC registration as a manufacturer of those controlled substances.
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 2014
This notice establishes the final adjusted 2014 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, as well as the 2014 aggregate production quotas for three recently temporarily controlled substances.
Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From Schedule III to Schedule II
With the issuance of this final rule, the Administrator of the Drug Enforcement Administration reschedules hydrocodone combination products from schedule III to schedule II 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 II controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities with, conduct chemical analysis with, or possess) or propose to handle hydrocodone combination products.
Electronic Prescriptions for Controlled Substances Notice of Approved Certification Process
The Drug Enforcement Administration (DEA) is announcing one new DEA-approved certification process for providers of Electronic Prescriptions for Controlled Substances (EPCS) applications. Certifying organizations with a certification process approved pursuant to 21 CFR 1311.300(e) are posted on DEA's Web site upon approval.
Importer of Controlled Substances Registration: Penick Corporation
Penick Corporation applied to be registered as an importer of certain basic classes of narcotic controlled substances. The DEA grants Penick Corporation registration as an importer of those controlled substances.
Importer of Controlled Substances Registration: Rhodes Technologies
Rhodes Technologies applied to be registered as an importer of certain basic classes of controlled substances. The DEA grants Rhodes Technologies registration as an importer of those controlled substances.
Importer of Controlled Substances Registration: Almac Clinical Services, Inc. (ACSI)
Almac Clinical Services, Inc. (ACSI) applied to be registered as an importer of certain basic classes of narcotic controlled substances. The Drug Enforcement Administration (DEA) grants Almac Clinical Services, Inc. (ACSI) registration as an importer of those controlled substances.
Importer of Controlled Substances Registration: Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC applied to be registered as an importer of a basic class of narcotic controlled substance. The Drug Enforcement Administration grants Fresenius Kabi USA, LLC registration as an importer of this controlled substance.
Importer of Controlled Substances Registration: Meridian Medical Technologies
Meridian Medical Technologies applied to be registered as an importer of a certain basic class of narcotic controlled substance. The DEA grants Meridian Medical Technologies registration as an importer of this controlled substance.
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 2015
The Drug Enforcement Administration proposes to establish the 2015 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.
Schedules of Controlled Substances: Placement of Tramadol Into Schedule IV
With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration places the substance 2- [(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol (tramadol), 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 with, or possess) or propose to handle tramadol.
Importer of Controlled Substances Registration: CODY LABORATORIES, INC.
Cody Laboratories, Inc. applied to be registered as an importer of certain basic classes of narcotic or non-narcotic controlled substances. The DEA grants Cody Laboratories, Inc. registration as an importer of those controlled substances.
Importer of Controlled Substances Registration: STEPAN COMPANY
Stepan Company applied to be registered as an importer of a basic class of a narcotic controlled substance. The DEA grants Stepan Company registration as an importer of this controlled substance.
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 2014
The Drug Enforcement Administration proposes to adjust the 2014 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.
Controlled Substances: 2014 Established Aggregate Production Quotas for 10 Temporarily Controlled Synthetic Cathinones
This notice establishes the initial 2014 aggregate production quotas for 10 temporarily controlled synthetic cathinones: 4-methyl-N- ethylcathinone (4-MEC); 4-methyl-[alpha]-pyrrolidinopropiophenone (4- MePPP); alpha-pyrrolidinopentiophenone ([alpha]-PVP); 1-(1,3- benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone); 2- (methylamino)-1-phenylpentan-1-one (pentedrone); 1-(1,3-benzodioxol-5- yl)-2-(methylamino)pentan-1-one (pentylone); 4-fluoro-N-methylcathinone (4-FMC); 3-fluoro-N-methylcathinone (3-FMC); naphthylpyrovalerone (naphyrone); and alpha-pyrrolidinobutiophenone ([alpha]-PBP).
Manufacturer of Controlled Substances Registration: Noramco, Inc.
Noramco, Inc. applied to be registered as a manufacturer of certain basic classes of narcotic or non-narcotic controlled substances. The DEA grants Noramco, Inc. registration as a manufacturer of those controlled substances.
Manufacturer of Controlled Substances Registration: Cayman Chemical Company
Cayman Chemical Company applied to be registered as a manufacturer of certain basic classes of narcotic or non-narcotic controlled substances. The DEA grants Cayman Chemical Company registration as a manufacturer of those controlled substances.
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