Drug Enforcement Administration August 2014 – Federal Register Recent Federal Regulation Documents

Schedules of Controlled Substances: Placement of Suvorexant into Schedule IV
Document Number: 2014-20515
Type: Rule
Date: 2014-08-28
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance [(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan- 1-yl][5- methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone (suvorexant), 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 suvorexant.
Controlled Substances: Adjustment to the Established 2014 Aggregate Production Quota for Marijuana
Document Number: 2014-20317
Type: Notice
Date: 2014-08-26
Agency: Drug Enforcement Administration, Department of Justice
This notice addresses a comment received as a result of a notice with request for comments published May 5, 2014, adjusting the established 2014 aggregate production quota for marijuana, a schedule I controlled substance under the Controlled Substances Act.
Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2014-20201
Type: Notice
Date: 2014-08-26
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration: SA INTL GMBH C/O., Sigma Aldrich Co., LLC
Document Number: 2014-20200
Type: Notice
Date: 2014-08-26
Agency: Drug Enforcement Administration, Department of Justice
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.
Document Number: 2014-20198
Type: Notice
Date: 2014-08-26
Agency: Drug Enforcement Administration, Department of Justice
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
Document Number: 2014-20196
Type: Notice
Date: 2014-08-26
Agency: Drug Enforcement Administration, Department of Justice
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.
Bulk Manufacturer of Controlled Substances Application: Chemtos, LLC
Document Number: 2014-20195
Type: Notice
Date: 2014-08-26
Agency: Drug Enforcement Administration, Department of Justice
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
Document Number: 2014-20137
Type: Notice
Date: 2014-08-25
Agency: Drug Enforcement Administration, Department of Justice
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.
Importer of Controlled Substances Application: CATALENT CTS, LLC; Correction
Document Number: 2014-20119
Type: Notice
Date: 2014-08-25
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From Schedule III to Schedule II
Document Number: 2014-19922
Type: Rule
Date: 2014-08-22
Agency: Drug Enforcement Administration, Department of Justice
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.
Glenn R. Unger, D.D.S.; Declaratory Order
Document Number: 2014-19785
Type: Notice
Date: 2014-08-20
Agency: Drug Enforcement Administration, Department of Justice
Electronic Prescriptions for Controlled Substances Notice of Approved Certification Process
Document Number: 2014-19783
Type: Notice
Date: 2014-08-20
Agency: Drug Enforcement Administration, Department of Justice
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 Application: United States Pharmacopeial Convention
Document Number: 2014-19775
Type: Notice
Date: 2014-08-20
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration: Penick Corporation
Document Number: 2014-19762
Type: Notice
Date: 2014-08-20
Agency: Drug Enforcement Administration, Department of Justice
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.
Bulk Manufacturer of Controlled Substances Application: Catalent CTS, LLC
Document Number: 2014-19447
Type: Notice
Date: 2014-08-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration: Rhodes Technologies
Document Number: 2014-19432
Type: Notice
Date: 2014-08-18
Agency: Drug Enforcement Administration, Department of Justice
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)
Document Number: 2014-18279
Type: Notice
Date: 2014-08-01
Agency: Drug Enforcement Administration, Department of Justice
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.