Drug Enforcement Administration 2014 – Federal Register Recent Federal Regulation Documents

Schedules of Controlled Substances: Temporary Placement of Three Synthetic Cannabinoids Into Schedule I
Document Number: 2014-29651
Type: Proposed Rule
Date: 2014-12-19
Agency: Drug Enforcement Administration, Department of Justice
The Deputy Administrator of the Drug Enforcement Administration is issuing this notice of intent to temporarily schedule three synthetic cannabinoids into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. The substances are: N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H- indazole-3-carboxamide (common name: AB-CHMINACA), N-(1-amino-3-methyl- 1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (common name: AB- PINACA) and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1- yl)methanone (common name: THJ-2201). This action is based on a finding by the Deputy Administrator that the placement of these synthetic cannabinoids into schedule I of the CSA 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 CSA on the manufacture, distribution, possession, importation, exportation, research, and conduct of instructional activities of these synthetic cannabinoids.
Electronic Prescriptions for Controlled Substances: Notice of Approved Certification Process
Document Number: 2014-29118
Type: Notice
Date: 2014-12-12
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is announcing one new DEA- approved certification process for providers of Electronic Prescriptions for Controlled Substances applications. Certifying organizations with an approved certification process are posted on the Drug Enforcement Administration's Web site upon approval.
Manufacturer of Controlled Substances Registration: Sigma Aldrich Research Biochemicals, Inc.
Document Number: 2014-29119
Type: Notice
Date: 2014-12-11
Agency: Drug Enforcement Administration, Department of Justice
Sigma Aldrich Research Biochemicals, Inc., applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Sigma Aldrich Research Biochemicals, Inc. registration as a manufacturer of those controlled substances.
Manufacturer of Controlled Substances Registration: Johnson Matthey Pharmaceutical Materials, Inc.
Document Number: 2014-29117
Type: Notice
Date: 2014-12-11
Agency: Drug Enforcement Administration, Department of Justice
Johnson Matthey Pharmaceutical Materials, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Johnson Matthey Pharmaceutical Materials, Inc. registration as a manufacturer of the controlled substances.
Exemption From Registration for Persons Authorized Under U.S. Nuclear Regulatory Commission or Agreement State Medical Use Licenses or Permits and Administering the Drug Product DaTscanTM
Document Number: 2014-27917
Type: Rule
Date: 2014-11-25
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is amending its regulations to waive the requirement of registration for persons who are authorized under United States Nuclear Regulatory Commission or Agreement State medical use licenses or permits and administer the drug product DaTscan\TM\.
Richard D. Vitalis, D.O.; Decision and Order
Document Number: 2014-27206
Type: Notice
Date: 2014-11-18
Agency: Drug Enforcement Administration, Department of Justice
Manufacturer of Controlled Substances Registration: Alltech Associates, Inc.
Document Number: 2014-26448
Type: Notice
Date: 2014-11-07
Agency: Drug Enforcement Administration, Department of Justice
Alltech Associates, Inc., applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Alltech Associates, Inc. registration as a manufacturer of those controlled substances.
Martin L. Korn, M.D.; Decision and Order
Document Number: 2014-26447
Type: Notice
Date: 2014-11-07
Agency: Drug Enforcement Administration, Department of Justice
Michael A. White, M.D.; Decision and Order
Document Number: 2014-25025
Type: Notice
Date: 2014-10-21
Agency: Drug Enforcement Administration, Department of Justice
Fiaz Afzal, M.D.; Decision And Order
Document Number: 2014-24373
Type: Notice
Date: 2014-10-14
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2014-24081
Type: Notice
Date: 2014-10-08
Agency: Drug Enforcement Administration, Department of Justice
Manufacturer of Controlled Substances Registration: Siemens Healthcare Diagnostics, Inc.
Document Number: 2014-24035
Type: Notice
Date: 2014-10-08
Agency: Drug Enforcement Administration, Department of Justice
Siemens Healthcare Diagnostics, Inc., applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Siemens Healthcare Diagnostics, Inc. registration as a manufacturer of those controlled substances.
Importer of Controlled Substances Registration: Alkermes Gainesville LLC
Document Number: 2014-24032
Type: Notice
Date: 2014-10-08
Agency: Drug Enforcement Administration, Department of Justice
Alkermes Gainesville LLC applied to be registered as an importer of a basic class of controlled substance. The DEA grants Alkermes Gainesville LLC registration as an importer of this controlled substance.
Manufacturer of Controlled Substances Registration: Austin Pharma, LLC
Document Number: 2014-24018
Type: Notice
Date: 2014-10-08
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 DEA grants Austin Pharma, LLC registration as a manufacturer of those controlled substances.
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey, Inc.
Document Number: 2014-23833
Type: Notice
Date: 2014-10-07
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2014-23832
Type: Notice
Date: 2014-10-07
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.
Document Number: 2014-23831
Type: Notice
Date: 2014-10-07
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration: Alltech Associates, Inc.
Document Number: 2014-23830
Type: Notice
Date: 2014-10-07
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 DEA grants Alltech Associates, Inc., registration as an importer of those controlled substances.
Importer of Controlled Substances Registration: R & D Systems, Inc.
Document Number: 2014-23829
Type: Notice
Date: 2014-10-07
Agency: Drug Enforcement Administration, Department of Justice
R & D Systems, Inc., applied to be registered as an importer of certain basic classes of controlled substances. The DEA grants R & D Systems, Inc., registration as an importer of those controlled substances.
Importer of Controlled Substances Registration: Meda Pharmaceuticals, Inc.
Document Number: 2014-23828
Type: Notice
Date: 2014-10-07
Agency: Drug Enforcement Administration, Department of Justice
Meda Pharmaceuticals, Inc., applied to be registered as an importer of a certain basic class of controlled substance. The DEA grants Meda Pharmaceuticals, Inc., registration as an importer of this controlled substance.
Importer of Controlled Substances Application: Chattem Chemicals, Inc.
Document Number: 2014-23827
Type: Notice
Date: 2014-10-07
Agency: Drug Enforcement Administration, Department of Justice
The Medicine Shoppe; Decision and Order
Document Number: 2014-23473
Type: Notice
Date: 2014-10-02
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc.
Document Number: C1-2014-21062
Type: Notice
Date: 2014-09-11
Agency: Drug Enforcement Administration, Department of Justice
Disposal of Controlled Substances
Document Number: 2014-20926
Type: Rule
Date: 2014-09-09
Agency: Drug Enforcement Administration, Department of Justice
This rule governs the secure disposal of controlled substances by registrants and ultimate users. These regulations will implement the Secure and Responsible Drug Disposal Act of 2010 by expanding the options available to collect controlled substances from ultimate users for the purpose of disposal, including: Take-back events, mail-back programs, and collection receptacle locations. These regulations contain specific language allowing law enforcement to voluntarily continue to conduct take-back events, administer mail-back programs, and maintain collection receptacles. These regulations will allow authorized manufacturers, distributors, reverse distributors, narcotic treatment programs (NTPs), hospitals/clinics with an on-site pharmacy, and retail pharmacies to voluntarily administer mail-back programs and maintain collection receptacles. In addition, this rule expands the authority of authorized hospitals/clinics and retail pharmacies to voluntarily maintain collection receptacles at long-term care facilities. This rule also reorganizes and consolidates previously existing regulations on disposal, including the role of reverse distributors.
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 2015
Document Number: 2014-21280
Type: Notice
Date: 2014-09-08
Agency: Drug Enforcement Administration, Department of Justice
This notice establishes the initial 2015 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 Registration: Wildlife Laboratories, Inc.
Document Number: 2014-21087
Type: Notice
Date: 2014-09-04
Agency: Drug Enforcement Administration, Department of Justice
Wildlife Laboratories, Inc., applied to be registered as an importer of certain basic classes of controlled substances. The DEA grants Wildlife Laboratories, Inc., registration as an importer of those controlled substances.
Importer of Controlled Substances Registration: Arizona Department of Corrections, Aspc-Florence
Document Number: 2014-21083
Type: Notice
Date: 2014-09-04
Agency: Drug Enforcement Administration, Department of Justice
Arizona Department of Corrections, ASPC-Florence applied to be registered as an importer of a certain basic class of controlled substance. The DEA grants Arizona Department of Corrections, ASPC- Florence registration as an importer of this controlled substance.
Manufacturer of Controlled Substances Registration: National Center for Natural Products Research (NIDA MProject), Inc.
Document Number: 2014-21077
Type: Notice
Date: 2014-09-04
Agency: Drug Enforcement Administration, Department of Justice
National Center for Natural Products Research (NIDA MProject), Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants National Center for Natural Products Research (NIDA MProject), Inc., registration as a manufacturer of those controlled substances.
Importer of Controlled Substances Registration: Akorn, Inc.
Document Number: 2014-21063
Type: Notice
Date: 2014-09-04
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 DEA grants Akorn, Inc., registration as an importer of this controlled substance.
Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc.
Document Number: 2014-21062
Type: Notice
Date: 2014-09-04
Agency: Drug Enforcement Administration, Department of Justice
Manufacturer of Controlled Substances Registration: Organix, Inc.
Document Number: 2014-21060
Type: Notice
Date: 2014-09-04
Agency: Drug Enforcement Administration, Department of Justice
Organix, Inc. applied to be registered as a manufacturer of certain basic classes of narcotic and non-narcotic controlled substances. The DEA grants Organix, Inc. registration as a manufacturer of those controlled substances.
Importer of Controlled Substances Application: Cody Laboratories, Inc.
Document Number: 2014-21058
Type: Notice
Date: 2014-09-04
Agency: Drug Enforcement Administration, Department of Justice
On July 3, 2014, Cody Laboratories, Inc., Cody, Wyoming, applied to be registered as an importer of basic classes of controlled substances.
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2014-21056
Type: Notice
Date: 2014-09-04
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration: Mylan Technologies, Inc.
Document Number: 2014-21052
Type: Notice
Date: 2014-09-04
Agency: Drug Enforcement Administration, Department of Justice
Mylan Technologies, Inc., applied to be registered as an importer of certain basic classes of controlled substances. The DEA grants Mylan Technologies, Inc., registration as an importer of those controlled substances.
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.