Drug Enforcement Administration 2024 – Federal Register Recent Federal Regulation Documents
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Importer of Controlled Substances Application: Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Curia Wisconsin, Inc.
Curia Wisconsin, Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2025
The Drug Enforcement Administration (DEA) proposes to establish the 2025 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2024
The Drug Enforcement Administration proposes to adjust the 2024 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act. Additionally, as DEA announced in an April 29, 2024 letter to DEA-registered manufacturers, procurement quotas for commercial manufacturing of a schedule II controlled substance will be calculated on a semi-annual basis, except for injectable drug products containing schedule II controlled substances, which will be calculated on an annual basis.
Importer of Controlled Substances Application: Curium US LLC
Curium US LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Chemtos, LLC
Chemtos, LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories
Eli-Elsohly Laboratories has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Schedules of Controlled Substances: Temporary Placement of N-Pyrrolidino Metonitazene and N-Pyrrolidino Protonitazene in Schedule I
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule two synthetic benzimidazole-opioid substances, N-pyrrolidino metonitazene and N-pyrrolidino protonitazene, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible, in schedule I of the Controlled Substances Act. When it is issued, the temporary scheduling order will impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances 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 these two specified substances.
Importer of Controlled Substances Application: Purisys, LLC
Purisys, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Curia New York, Inc.
Curia New York, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Importer of Controlled Substances Application: Curia New York, Inc.
Curia New York, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Importer of Controlled Substances Application: Cambridge Isotope Laboratories, Inc.
Cambridge Isotope Laboratories, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Importer of Controlled Substances Application: Biopharmaceutical Research Company
Biopharmaceutical Research Company has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Importer of Controlled Substances Application: Bright Green Corporation
Bright Green Corporation has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Adjustment to the Aggregate Production Quota for Lisdexamfetamine and d-Amphetamine (for Conversion) for 2024
The Drug Enforcement Administration is adjusting the 2024 aggregate production quota for the schedule II controlled substances lisdexamfetamine and d-amphetamine (for conversion). In making this determination, DEA has considered the factors set forth in its regulations in accordance with the statutes and is expediting publication of this determination to comply with the timeframes specified in the statutes.
Bulk Manufacturer of Controlled Substances Application: Benuvia Operations, LLC
Benuvia Operations, LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Continuus Pharmaceuticals
Continuus Pharmaceuticals has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Importer of Controlled Substances Application: Indivior Inc.
Indivior Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Biopharmaceutical Research Company
Biopharmaceutical Research Company has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc.
Chattem Chemicals, Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Bright Green Corporation
Bright Green Corporation has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Importer of Controlled Substances Application: Catalent CTS, LLC
Catalent CTS, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Fisher Clinical Services, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Cambrex High Point, Inc
Cambrex High Point, Inc has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Importer of Controlled Substances Application: Chattem Chemicals
Chattem Chemicals has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Cambridge Isotope Laboratories, Inc.
Cambridge Isotope Laboratories, Inc has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Importer of Controlled Substances Application: Amneal Complex Products Research LLC
Amneal Complex Products Research LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Importer of Controlled Substances Application: Caligor Coghlan Pharma Services
Caligor Coghlan Pharma Services has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Schedules of Controlled Substances: Rescheduling of Marijuana
This is notice that the Drug Enforcement Administration will hold a hearing with respect to the proposed rescheduling of marijuana into schedule III of the Controlled Substances Act. The proposed rescheduling of marijuana was initially proposed in a Notice of Proposed Rulemaking published in the Federal Register on May 21, 2024.
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