Drug Enforcement Administration March 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
Schedules of Controlled Substances: Placement of FUB-AMB in Schedule I
The Drug Enforcement Administration (DEA) places methyl 2-(1- (4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. This action continues the imposition of 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 FUB-AMB.
Controls To Enhance the Cultivation of Marihuana for Research in the United States
The Drug Enforcement Administration is proposing to amend its regulations to comply with the requirements of the Controlled Substances Act, including consistency with treaty obligations, in order to facilitate the cultivation of marihuana for research purposes and other licit purposes. Specifically, this proposed rule would amend the provisions of the regulations governing applications by persons seeking to become registered with DEA to grow marihuana as bulk manufacturers and add provisions related to the purchase and sale of this marihuana by DEA.
Registration and Reregistration Fees for Controlled Substance and List I Chemical Registrants
The Drug Enforcement Administration proposes adjusting the fee schedule for registration and reregistration fees necessary to recover the costs of its Diversion Control Program relating to the registration and control of the manufacture, distribution, dispensing, importation and exportation of controlled substances and list I chemicals as mandated by the Controlled Substances Act.
Schedules of Controlled Substances: Placement of Cenobamate in Schedule V
On November 21, 2019, the U.S. Food and Drug Administration (FDA) approved a new drug application for XCOPRI (cenobamate) tablets. Cenobamate is chemically known as [(1R)-1-(2-chlorophenyl)-2-(tetrazol- 2-yl)ethyl] carbamate. Thereafter, the Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place cenobamate in schedule V of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing cenobamate, including its salts, in schedule V of the CSA.
Bulk Manufacturer of Controlled Substances Application: S&B Pharma, Inc.; Correction
The Drug Enforcement Administration (DEA) published a document in the Federal Register on November 22, 2019, concerning a notice of application. As that document correctly indicated, the applicant, S&B Pharma, Inc., DBA Norac Pharma, 405 South Motor Avenue, Azusa, California 91702-3232 applied to be registered as a bulk manufacturer of a number of controlled substances, to include applying for authorization in order to synthetically manufacture using drug code 7360 (marihuana). However, on the notice of application published, drug code 7360 was inadvertently identified and listed as Gamma Hydroxybutyric Acid instead of Marihuana.
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