Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents
Results 501 - 550 of 4,490
Bulk Manufacturer of Controlled Substances Application: Vici Health Sciences, LLC
Vici Health Sciences, 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.
Schedules of Controlled Substances: Placement of Amineptine in Schedule I
With the issuance of this final rule, the Drug Enforcement Administration places amineptine (chemical name: 7-[(10,11-dihydro-5H- dibenzo[a,d]cyclohepten-5-yl)amino]heptanoic acid), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. This action imposes 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 amineptine.
Default Provisions for Hearing Proceedings Relating to the Revocation, Suspension, or Denial of a Registration
The Drug Enforcement Administration (DEA) is amending its regulations by adding and revising provisions which enable DEA to hold registrants or applicants in default when they fail to timely request a hearing, or otherwise fail to participate in hearings. DEA is also amending its regulations to include an answer provision which will regulate how registrants respond to an Order to Show Cause (OTSC). These changes involve the revocation, suspension, or denial of a registration and do not affect other types of hearings.
Schedules of Controlled Substances: Placement of Ganaxolone in Schedule V
This final rule adopts, without change, an interim final rule with request for comments published in the Federal Register on June 1, 2022, placing ganaxolone (3[alpha]-hydroxy-3[beta]-methyl-5[alpha]- pregnan-20-one) and its salts in schedule V of the Controlled Substances Act. With the issuance of this final rule, the Drug Enforcement Administration maintains ganaxolone, including its salts, in schedule V of the Controlled Substances Act.
Specific Listing for 1-boc-4-AP, a Currently Controlled List I Chemical
The Drug Enforcement Administration (DEA) is establishing a specific listing and DEA Chemical Control Number for tert-butyl 4- (phenylamino)piperidine-1-carboxylate (also known as 1-boc-4-AP; and CAS Number: 125541-22-2) and its salts as a list I chemical under the Controlled Substances Act. Although 1-boc-4-AP is not specifically listed as a list I chemical of the Controlled Substances Act with its own unique Chemical Control Number, it has been regulated as a list I chemical in the United States since May 15, 2020, as a carbamate of N- phenylpiperidin-4-amine, a list I chemical. Therefore, DEA is simply amending the list I chemicals list in its regulations to include a separate listing for 1-boc-4-AP, a currently controlled list I chemical.
Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc.; Correction
The Drug Enforcement Administration (DEA) published a document in the Federal Register on October 11, 2022, concerning a notice of application that inadvertently did not include the controlled substance Cocaine (9041).
Technical Correction to Regulation Regarding Registration Exception for Officials
This final rule updates a Drug Enforcement Administration regulation involving exemption from registration for law enforcement officials by removing an inapposite cross-reference listing. This action makes no substantive changes to this regulation.
Bulk Manufacturer of Controlled Substances Application: Organix Chemistry Solutions LLC
Organix Chemistry Solutions 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: Noramco
Noramco 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: Mylan Technologies, Inc.
Mylan Technologies, 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: 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.
Bulk Manufacturer of Controlled Substances Application: Nanosyn Inc.
Nanoysn 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: Benuvia Manufacturing, Inc.
Benuvia Manufacturing 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: Bulk Manufacturer of Marihuana: Morrison Newfound Valley Manufacturing
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: Nexus Pharmaceuticals, Inc.
Nexus Pharmaceuticals, 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: 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: Bulk Manufacturer of Marihuana: Rocky Mountain Biotech, LLC
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: Organic Standards Solutions International, LLC
Organic Standards Solutions International, 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: National Center for Natural Products Research
National Center for Natural Products Research 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 2023
The Drug Enforcement Administration (DEA) proposes to establish the 2023 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.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Irvine Labs, 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: 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.
Importer of Controlled Substances Application: National Center for Natural Products Research
National Center for Natural Products Research 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: Groff NA Hemplex LLC
Groff NA Hemplex 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: 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.
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: Hybrid Pharma
Hybrid Pharma 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: 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.
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: Chattem Chemicals, Inc.
Chattem Chemicals, 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: Groff NA Hemplex LLC
Groff NA Hemplex 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: Curia Wisconsin, Inc.
Curia Wisconsin, 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: 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.
Schedules of Controlled Substances: Placement of Daridorexant in Schedule IV
This final rule adopts without change an interim final rule with request for comments published in the Federal Register on April 7, 2022, placing daridorexant ([(S)-2-(5-chloro-4-methyl-1H- benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl](5-methoxy-2-( 2H-1,2,3- triazol-2-yl)phenyl)methanone), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of such isomers is possible, in schedule IV of the Controlled Substances Act (CSA). With the issuance of this final rule, the Drug Enforcement Administration maintains daridorexant in schedule IV of the CSA.
Designation of 4-Piperidone as a List I Chemical
The Drug Enforcement Administration is proposing the control of 4-piperidone, its acetals, its amides, its carbamates, its salts, and salts of its acetals, its amides, and its carbamates, whenever the existence of such is possible, as a list I chemical under the Controlled Substances Act. The Drug Enforcement Administration finds that 4-piperidone is used in the illicit manufacture of the controlled substance fentanyl, and is important to the manufacture of the controlled substance fentanyl because it cannot be replaced by other chemicals in its respective synthetic pathways which are used in the illicit manufacture of fentanyl. If finalized, this action would subject handlers of 4-piperidone to the chemical regulatory provisions of the Controlled Substances Act and its implementing regulations. This rulemaking does not establish a threshold for domestic and international transactions of 4-piperidone. As such, all transactions of chemical mixtures containing 4-piperidone will be regulated at any concentration and will be subject to control under the Controlled Substances Act.
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.
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.
Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company
Cayman Chemical 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.
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.
Importer of Controlled Substances Application: Experic LLC
Experic 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.
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