Drug Enforcement Administration 2019 – Federal Register Recent Federal Regulation Documents

The registrant listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as an importer of schedule I controlled substances.

On March 19, 2019, the U.S. Food and Drug Administration (FDA) approved a new drug application for Zulresso (brexanolone). Brexanolone is chemically known as 3[alpha]-hydroxy-5[alpha]-pregnan-20-one and is also referred to as allopregnanolone. The Department of Health and Human Services (HHS) provided the Drug Enforcement Administration (DEA) with a recommendation that brexanolone be placed in schedule IV 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 brexanolone (including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible) in schedule IV of the CSA.

The registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of schedule I and schedule II controlled substances.

The registrant listed below has applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of various classes of schedule I controlled substances.

The Drug Enforcement Administration is correcting a final order that appeared in the Federal Register on November 29, 2018. The document issued an action maintaining the placement of furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil, including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. A drafting oversight in the amendatory instructions did not correctly update the prefatory language on isomers to reflect the change in the paragraph number for the designation of 3-methylthiofentanyl.

The Drug Enforcement Administration is amending its hearing regulations to provide that, when the presiding officer of an administrative hearing denies an interlocutory appeal, he shall transmit his determination to the Drug Enforcement Administration Administrator for discretionary review.

The Acting Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic cannabinoids (SC), ethyl 2-(1-(5-fluoropentyl)-1H- indazole-3-carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-EDMB- PINACA); methyl 2-(1-(5-fluoropentyl)-1H-indole-3-carboxamido)-3,3- dimethylbutanoate (trivial name: 5F-MDMB-PICA); N-(adamantan-1-yl)-1- (4-fluorobenzyl)-1H-indazole-3-carboxamide (trivial names: FUB-AKB48; FUB-APINACA; AKB48 N-(4-FLUOROBENZYL)); 1-(5-fluoropentyl)-N-(2- phenylpropan-2-yl)-1H-indazole-3-carboxamide (trivial names: 5F-CUMYL- PINACA; SGT-25); and (1-(4-fluorobenzyl)-1H-indol-3-yl)(2,2,3,3- tetramethylcyclopropyl) methanone (trivial name: FUB-144), and their optical, positional, and geometric isomers, salts, and salts of isomers in schedule I. This action is based on a finding by the Acting Administrator that the placement of these SCs in schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB- AKB48, 5F-CUMYL-PINACA or FUB-144.

The Drug Enforcement Administration proposes placing methyl 2- (1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbu tanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole-3- carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5- fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1- amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-ind azole-3- carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1H-indole-3- carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3- dimethylbutanoate [MDMB-FUBINACA], including their 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. If finalized, this action would make permanent the existing 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 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA.

The Acting Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of six synthetic cannabinoids (SC). The substances are: methyl 2-(1-(5-fluoropentyl)-1H-indazole-3- carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2- (1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutano ate [5F- AMB]; N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxami de [5F-APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4- fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1- (cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutan oate [MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1H- indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA], including their optical, positional and geometric isomers, salts, and salts of isomers. The schedule I status of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA will expire on April 10, 2019. This temporary order will extend the temporary scheduling of 5F- ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA for one year or until the permanent scheduling action for these six substances is completed, whichever occurs first.

The applicant listed below has submitted an application for registration to the Drug Enforcement Administration (DEA) to become an importer of schedule I controlled substances.