Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 4,445
Bulk Manufacturer of Controlled Substances Application: Curia Missouri Inc.
Curia Missouri 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: Arizona Department of Corrections
Arizona Department of Corrections 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: AndersonBrecon Inc. DBA PCI Pharma Services
AndersonBrecon, Inc. DBA PCI 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.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Lily's Eden Garden Farms Corporation
The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.
Announcement of Stayed Hearing: Schedules of Controlled Substances: Placement of 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) in Schedule I
This is a notification that the Drug Enforcement Administration has stayed the June 10, 2024 hearing on the proposed placement of two phenethylamine hallucinogens, as identified in the proposed rule, in schedule I of the Controlled Substances Act.
Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chem
American Radiolabeled Chem 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: Veranova, L.P.
Veranova, L.P., 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: Usona Institute
Usona Institute 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: Unither Manufacturing LLC
Unither Manufacturing 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: ANI Pharmaceuticals, Inc.
ANI Pharmaceuticals, 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: Royal Emerald Pharmaceuticals
Royal Emerald Pharmaceuticals 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: United States Pharmacopeial Convention
United States Pharmacopeial Convention 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: Quagen Pharmaceuticals LLC
Quagen Pharmaceuticals 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: Skalar Pharma, LLC
Skalar Pharma, 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: AMPAC Fine Chemicals Virginia LLC
AMPAC Fine Chemicals Virginia 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: Royal Emerald Pharmaceuticals
Royal Emerald 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: VA Cooperative Studies Program
VA Cooperative Studies Program 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: ANI Pharmaceuticals Inc.
ANI Pharmaceuticals Inc., 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: Revvity, Inc.
Revvity, 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: Veranova, L.P.
Veranova, L.P. 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: Vici Health Sciences, LLC
Vici Health Sciences, 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: Almac Clinical Services Incorporate
Almac Clinical Services Incorp (ACSI) 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: Pharmaron Manufacturing Services (US) LLC; Correction
The Drug Enforcement Administration (DEA) published a document in the Federal Register on May 6, 2024, concerning an application for a Bulk Manufacturer of Controlled Substances. A request was made for the removal of the following information: "The company plans to bulk manufacture the listed controlled substances for the purpose of producing material for clinical trials." Please correct notice to read as follows as stated under Supplementary Information.
Schedules of Controlled Substances: Rescheduling of Marijuana
The Department of Justice ("DOJ") proposes to transfer marijuana from schedule I of the Controlled Substances Act ("CSA") to schedule III of the CSA, consistent with the view of the Department of Health and Human Services ("HHS") that marijuana has a currently accepted medical use as well as HHS's views about marijuana's abuse potential and level of physical or psychological dependence. The CSA requires that such actions be made through formal rulemaking on the record after opportunity for a hearing. If the transfer to schedule III is finalized, the regulatory controls applicable to schedule III controlled substances would apply, as appropriate, along with existing marijuana-specific requirements and any additional controls that might be implemented, including those that might be implemented to meet U.S. treaty obligations. If marijuana is transferred into schedule III, the manufacture, distribution, dispensing, and possession of marijuana would remain subject to the applicable criminal prohibitions of the CSA. Any drugs containing a substance within the CSA's definition of "marijuana" would also remain subject to the applicable prohibitions in the Federal Food, Drug, and Cosmetic Act ("FDCA"). DOJ is soliciting comments on this proposal.
Exempt Chemical Preparations Under the Controlled Substances Act
The applications for exempt chemical preparations received by the Drug Enforcement Administration between April 28, 2022, and September 30, 2023, as listed below, were accepted for filing and have been approved or denied as indicated.
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.
Bulk Manufacturer of Controlled Substances Application: Veranova, L.P.
Veranova, L.P. 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: Wedgewood Village Pharmacy, LLC
Wedgewood Village Pharmacy, 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: Pharmaron Manufacturing Services (US) LLC
Pharmaron Manufacturing Services (US) 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.
Importer of Controlled Substances Application: Restek Corporation
Restek 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.
Importer of Controlled Substances Application: Lipomed
Lipomed 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: Bulk Manufacturer of Marihuana: Entheogen Pharmaceuticals Inc
The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.
Importer of Controlled Substances Application: AndersonBrecon dba PCI Pharma Services
AndersonBrecon dba PCI 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.
Importer of Controlled Substances Application: AndersonBrecon dba PCI Pharma Services; Correction
The Drug Enforcement Administration (DEA) published a document in the Federal Register on March 6, 2024, concerning an application for an Importer of Controlled Substances. The document request removal of Dimethyltrytamine.
Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute
Research Triangle Institute 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: NSI Lab Solutions, Inc.
NSI Lab Solutions, 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: Pisgah Laboratories Inc.
Pisgah 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.
Schedules of Controlled Substances: Placement of Etodesnitazene, N-Pyrrolidino Etonitazene, and Protonitazene in Schedule I
With the issuance of this final order, the Administrator of the Drug Enforcement Administration is permanently placing 2-(2-(4- ethoxybenzyl)-1H-benzimidazol-1-yl)-N,N-diethylethan-1-amine (other names: etodesnitazene; etazene), 2-(4-ethoxybenzyl)-5-nitro-1-(2- (pyrrolidin-1-yl)ethyl)-1H-benzimidazole (other names: N-pyrrolidino etonitazene; etonitazepyne), and N,N-diethyl-2-(5-nitro-2-(4- propoxybenzyl)-1H-benzimidazol-1-yl)ethan-1-amine (other name: protonitazene), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts are possible within the specific chemical designation, in schedule I of the Controlled Substances Act. This scheduling action discharges the United States' obligations under the Single Convention on Narcotic Drugs (1961). This action imposes permanent 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 or conduct instructional activities with, or possess), or handle etodesnitazene, N-pyrrolidino etonitazene, and protonitazene.
Schedules of Controlled Substances: Placement of Butonitazene, Flunitazene, and Metodesnitazene Substances in Schedule I
The Drug Enforcement Administration proposes placing butonitazene, flunitazene, and metodesnitazene including their isomers, esters, ethers, salts and salts of isomers, esters and ethers 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, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle these three specific controlled substances.
Schedules of Controlled Substances: Extension of Temporary Placement of Butonitazene, Flunitazene, and Metodesnitazene in Schedule I of the Controlled Substances Act
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of butonitazene, flunitazene, and metodesnitazene, as identified in this order. The schedule I status of these three substances currently is in effect through April 12, 2024. This temporary order will extend the temporary scheduling of these three substances for one year, or until the permanent scheduling action for these substances is completed, whichever occurs first.
Importer of Controlled Substances Application: Lyndra Therapeutics
Lyndra Therapeutics 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: VHG Labs dba LGC Standards
VHG Labs dba LGC Standards 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.
Announcement of Hearing: Schedules of Controlled Substances: Placement of 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) inSchedule I
This is notification that the Drug Enforcement Administration will hold a hearing with respect to the proposed placement of two phenethylamine hallucinogens, as identified in the proposed rule, in schedule I of the Controlled Substances Act.
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