Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

The Acting Administrator of the Drug Enforcement Administration (DEA) is issuing this temporary scheduling order to schedule the synthetic cathinones, N-ethylhexedrone (2-(ethylamino)-1- phenylhexan-1-one); alpha-pyrrolidinohexanophenone (1-phenyl-2- (pyrrolidin-1-yl)hexan-1-one; alpha-pyrrolidinohexiophenone; trivial name: [alpha]-PHP); 4-methyl-alpha-ethylaminopentiophenone (2- (ethylamino)-1-(4-methylphenyl)pentan-1-one; trivial name: 4-MEAP); 4'- methyl-alpha-pyrrolidinohexiophenone (1-(4-methylphenyl)-2-(pyrrolidin- 1-yl)hexan-1-one; 4'-methyl-alpha-pyrrolidinohexanophenone; trivial name: MPHP); alpha-pyrrolidinoheptaphenone (1-phenyl-2-(pyrrolidin-1- yl)heptan-1-one; trivial name: PV8); and 4'-chloro-alpha- pyrrolidinovalerophenone (1-(4-chlorophenyl)-2-(pyrrolidin-1-yl)pentan- 1-one; 4'-chloro-alpha-pyrrolidinopentiophenone; trivial name: 4- chloro-[alpha]-PVP), 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 synthetic cathinones 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, possess, import, export, research, or conduct instructional activities or chemical analysis), or propose to handle, N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro- [alpha]-PVP.

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

On August 26, 2016, the Drug Enforcement Administration (DEA) published in the Federal Register an interim final rule with request for comments placing the substance thiafentanil, including its isomers, esters, ethers, salts and salts of isomers, esters and ethers, in schedule II of the Controlled Substances Act. This final rule adopts that interim final rule without change.

On March 20, 2019, the U.S. Food and Drug Administration approved a new drug application for SUNOSI, a drug product consisting of solriamfetol ((R)-2-amino-3-phenylpropyl carbamate hydrochloride) tablets for oral use. Thereafter, the Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place solriamfetol 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 solriamfetol, 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 registrant listed below has applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of a basic class of 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 and II controlled substances.

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

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

With the issuance of this final rule, the Drug Enforcement Administration places beta-hydroxythiofentanyl (N-[1-[2-hydroxy-2- (thiophen-2-yl)ethyl]piperidin-4-yl]-N-phenylpropionamide), also known as N-[1-[2-hydroxy-2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenyl- propanamide, including its isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. This rule 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 beta-hydroxythiofentanyl.

The Acting Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule the synthetic cathinones, N-ethylhexedrone; alpha- pyrrolidinohexanophenone (trivial name: [alpha]-PHP); 4-methyl-alpha- ethylaminopentiophenone (trivial name: 4-MEAP); 4'-methyl-alpha- pyrrolidinohexiophenone (trivial name: MPHP); alpha- pyrrolidinoheptaphenone (trivial name: PV8); and 4-chloro-alpha- pyrrolidinovalerophenone (trivial name: 4-chloro-[alpha]-PVP), in schedule I. When it is issued, the temporary scheduling order will impose regulatory requirements under the Controlled Substances Act (CSA) on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, conduct of instructional activities, and chemical analysis of these synthetic cathinones, as well as administrative, civil, and criminal remedies with respect to persons who fail to comply with such requirements or otherwise violate the CSA with respect to these substances.