Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

The Drug Enforcement Administration (DEA) is providing notice of certain applications it has received from entities applying to be registered to manufacture in bulk a basic class of controlled substances listed in schedule I. Prior to making decisions on these pending applications, DEA intends to promulgate regulations that govern the program of growing marihuana for scientific and medical research under DEA registration. In addition, this notice informs applicants that they may withdraw their applications if they no longer need to obtain a registration because of the recent amendments made by the Agriculture Improvement Act of 2018 to the definition of marihuana to no longer include ``hemp'' as defined by law.

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

The Drug Enforcement Administration (DEA) proposes to remove (5[alpha],6[beta])-17-(cyclopropylmethyl)-4,5-epoxymorphinan- 3,6,14- triol (6[beta]-naltrexol) and its salts from the schedules of the Controlled Substances Act (CSA). This scheduling action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. 6[beta]-Naltrexol is currently a schedule II controlled substance because it can be derived from opium alkaloids. This action would remove the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle 6[beta]-naltrexol.

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.