Drug Enforcement Administration 2014 – Federal Register Recent Federal Regulation Documents

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.

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.

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.

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.

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.

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.

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.

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.

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.

On July 3, 2014, Cody Laboratories, Inc., Cody, Wyoming, applied to be registered as an importer of basic classes of controlled substances.

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.

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.

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.

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.

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.

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.

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.

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.

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.