Drug Enforcement Administration June 2019 – Federal Register Recent Federal Regulation Documents
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Schedules of Controlled Substances: Placement of Thiafentanil in Schedule II
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.
Importer of Controlled Substances Registration
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.
Schedules of Controlled Substances: Placement of Solriamfetol in Schedule IV
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.
Schedules of Controlled Substances: Placement of Brexanolone in Schedule IV
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.
Bulk Manufacturer of Controlled Substances Registration
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.
Bulk Manufacturer of Controlled Substances Registration
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.
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