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Browse 38 rules and proposed rules from the Federal Register.
38
Total Regulations
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The Drug Enforcement Administration is finalizing the control of propionyl chloride as a list I chemical under the Controlled Substances Act (CSA). Propionyl chloride is used in the illicit manufacture of the controlled substances fentanyl, fentanyl analogues, and fentanyl-related substances, and it is important to the manufacture of these substances. This final rule subjects handlers of propionyl chloride to the chemical regulatory provisions of the CSA and its implementing regulations.
With the issuance of this final rule, the Drug Enforcement Administration places clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam and their salts, isomers, and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, in schedule I of the Controlled Substances Act. These five substances were temporarily scheduled in an order dated July 26, 2023, and subsequently extended until July 26, 2026, pursuant to an extension published elsewhere in this issue of the Federal Register. This action also enables the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. This action makes 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, or possess), or propose to handle these five specific controlled substances.
The "Protecting Patient Access to Emergency Medications Act of 2017," (the Act) which became law on November 17, 2017, amended the Controlled Substances Act (CSA) to allow for a new registration category for emergency medical services agencies that handle controlled substances. It also established standards for registering emergency medical services agencies, and set forth new requirements for delivery, storage, and recordkeeping related to their handling of controlled substances. In addition, the Act allows emergency medical services professionals to administer controlled substances outside the physical presence of a medical director or authorizing medical professional pursuant to a valid standing or verbal order. The Drug Enforcement Administration is publishing this final rule to conform its regulations to the statutory amendments of the CSA and to otherwise implement its requirements. This final rule adopts, with minor modifications, the notice of proposed rulemaking published on October 5, 2020.
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule 2-(2-fluorophenyl)-2-(methylamino)cyclohexan-1-one (commonly known as 2-fluorodeschloroketamine or 2-FDCK), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, 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 with, or possess) or propose to handle 2-fluorodeschloroketamine.
The Drug Enforcement Administration is publishing this final rule to amend its regulations related to "cannabimimetic agents" by including the term's definition, identifying 18 additional substances that meet the definition, and consolidating most existing administration controlled substances code numbers (drug codes) into a single drug code number for substances that meet this definition. The listing for two schedule I "cannabimimetic agents" that are under international control, JWH-018 and AM2201, are moved to the "hallucinogens" paragraph of schedule I but retain their existing drug codes to facilitate quota and international reporting requirements. While this final rule does not change the current and continuing schedule I status for the 18 additional substances meeting the definition of "cannabimimetic agents," these and other substances meeting this definition will be assigned a new administration controlled substances code number once this final rule becomes effective.
With the issuance of this final rule, the Drug Enforcement Administration places 4-fluoroamphetamine (4-FA; 1-(4- fluorophenyl)propan-2-amine; para-fluoroamphetamine), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken, in part, 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, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle 4-fluoroamphetamine.
With the issuance of this final order, the Administrator of the Drug Enforcement Administration is permanently placing 2-(4- methoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)-1H-benzimidazole (other names: N-pyrrolidino metonitazene or metonitazepyne) and 5- nitro-2-(4-propoxybenzyl)-1-(2-(pyrrolidin-1-yl)ethyl)-1H-benzimidazole (other names: N-pyrrolidino protonitazene or protonitazepyne), 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 under the Controlled Substances Act. This action is being taken, in part, to enable the United States to meet its obligations under the 1961 Single Convention on Narcotic Drugs. 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 N-pyrrolidino metonitazene and N-pyrrolidino protonitazene.
The Drug Enforcement Administration (DEA) jointly with the Department of Health and Human Services (HHS) is issuing a fourth extension of telemedicine flexibilities for the prescribing of controlled medications through December 31, 2026.
With the issuance of this final order, the Administrator of the Drug Enforcement Administration is permanently placing N-ethyl-2- (2-(4-isopropoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)ethan-1-amine (other name: N-desethyl isotonitazene) and 2-(4-ethoxybenzyl)-5-nitro- 1-(2-(piperidin-1-yl)ethyl)-1H-benzimidazole (other names: N- piperidinyl etonitazene; etonitazepipne), 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 under 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 N-desethyl isotonitazene and N-piperidinyl etonitazene.
The Drug Enforcement Administration proposes placing methyl 2- [[1-(4-fluorobutyl)indole-3-carbonyl]amino]-3,3-dimethylbutanoate (other names: 4F-MDMB-BUTICA; 4F-MDMB-BICA), N-(1-amino-3,3-dimethyl-1- oxobutan-2-yl)-1-(pent-4-en-1-yl)-1H-indazole-3-carboxamide (other name: ADB-4en-PINACA), ethyl 2-[[1-(5-fluoropentyl)indole-3- carbonyl]amino]-3,3-dimethyl-butanoate (other names: 5F-EDMB-PICA; 5F- EDMB-2201), and methyl 2-(1-(4-fluorobenzyl)-1H-indole-3-carboxamido)- 3-methyl butanoate (other name: MMB-FUBICA), including their salts, isomers (including optical, positional, and geometric isomers), and salts of isomers, in schedule I of the Controlled Substances Act. 4F- MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA were temporarily scheduled in an order dated December 12, 2023. 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 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, or MMB-FUBICA.
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA. The schedule I status of 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA is in effect through December 12, 2025. This temporary order will extend the temporary scheduling of these four substances for one year, or until the permanent scheduling action for these substances is completed, whichever occurs first. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will continue to be imposed 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 4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA.
The Administrator of the Drug Enforcement Administration is issuing this notification of intent to publish a temporary order to schedule 8-bromo-1-methyl-6-phenyl-4H-benzo[f][1,2,4]triazolo[4,3-a][l, 4]diazepine (commonly known as bromazolam), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers are 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 bromazolam.
The Drug Enforcement Administration proposes placing the substance CUMYL-PEGACLONE (SGT-151; 5-pentyl-2-(2-phenylpropan-2- yl)pyrido[4,3-b]indol-1-one), including its salts, isomers (including optical, positional, and geometric isomers), and salts of isomers, in schedule I of the Controlled Substances Act. CUMYL-PEGACLONE was temporarily scheduled in an order dated December 12, 2023. This action is being taken, in part, to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. 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 CUMYL-PEGACLONE.
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of MDMB-4en-PINACA. The schedule I status of MDMB- 4en-PINACA is in effect through December 12, 2025. This temporary order will extend the temporary scheduling of MDMB-4en-PINACA for one year, or until the permanent scheduling action for this substance is completed, whichever occurs first. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will continue to be imposed 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 MDMB-4en-PINACA.
The Administrator of the Drug Enforcement Administration (DEA) is issuing this temporary scheduling order to extend the temporary schedule I status of CUMYL-PEGACLONE. In an order dated December 12, 2023, DEA temporarily placed CUMYL-PEGACLONE in schedule I of the Controlled Substances Act. This temporary order will extend the temporary scheduling of CUMYL-PEGACLONE for one year, or until the permanent scheduling action for this substance is completed, whichever occurs first. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will continue to be imposed 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 CUMYL-PEGACLONE.
With the issuance of this final rule, the Drug Enforcement Administration places 4-chloromethcathinone (4-CMC, 1-(4-chlorophenyl)- 2-(methylamino)propan-1-one), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken, in part, 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, reverse distribute, import export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle 4- chloromethcathinone.
The Drug Enforcement Administration issues this temporary order to schedule seven benzimidazole-opioids, as identified in this order, in schedule I of the Controlled Substances Act. DEA bases this action on a finding that placing these substances in schedule I is necessary to avoid imminent hazard to public safety. This order imposes 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 substances.
The Drug Enforcement Administration (DEA) is establishing a specific listing and DEA Chemical Code Number for tert-butyl 4- oxopiperidine-1-carboxylate (also known as 1-boc-4-piperidone; and CAS Number: 79099-07-3) and its salts as a list I chemical under the Controlled Substances Act (CSA). Although 1-boc-4-piperidone is not specifically listed as a list I chemical of the CSA with its own unique Chemical Code Number, it has been regulated as a list I chemical in the United States as a carbamate of 4-piperidone, a list I chemical, since May 12, 2023. Therefore, DEA is simply amending the list of list I chemicals in its regulations to separately include 1-boc-4-piperidone.
This final rule updates an existing Drug Enforcement Administration (DEA) regulation by removing the reference to paper payments by check or money order for all applications for DEA registrations and renewal of those registrations. This action makes no substantive changes to this regulation.
This rule is amending the Drug Enforcement Administration's (DEA) regulations to conform to the Controlled Substances Ordering System (CSOS) modernization effort by requiring all CSOS enrollment applications and supporting materials to be submitted through the Diversion Control Division secure online portal. These amendments improve the enrollment process by aligning it with DEA's current requirements for other online form submissions. The online submission of enrollment applications and supporting material through the secure online portal increases the efficiency of the enrollment, modification, and revocation processes, and ensures DEA's receipt of accurate documentation in a more timely and organized manner.
The Drug Enforcement Administration proposes placing methyl 3,3-dimethyl-2-(1-(pent-4-en-1-yl)-1H-indazole-3-carboxamido)butanoate (other name: MDMB-4en-PINACA), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. This action is being taken, in part, to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. 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, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle MDMB-4en-PINACA.
The Drug Enforcement Administration is proposing the control of the chemical 2-methyl-3-phenyloxirane-2-carboxylic acid (also known as P2P methyl glycidic acid and BMK glycidic acid) and its esters, its optical and geometric isomers, its salts, salts of its optical and geometric isomers and its esters, and any combination thereof, whenever the existence of such is possible, as a list I chemical under the Controlled Substances Act (CSA). P2P methyl glycidic acid is important to the manufacture of the schedule II controlled substances phenylacetone (also known as phenyl-2-propanone or P2P), methamphetamine, and amphetamine, and it is used in clandestine laboratories to illicitly manufacture these controlled substances. If finalized, this proposed rule would subject handlers of P2P methyl glycidic acid to the chemical regulatory provisions of the CSA and its implementing regulations. This rulemaking does not establish a threshold for domestic and international transactions of P2P methyl glycidic acid. As such, all transactions of P2P methyl glycidic acid, regardless of size, shall be regulated. In addition, chemical mixtures containing P2P methyl glycidic acid are not exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical mixtures containing any quantity of P2P methyl glycidic acid shall be regulated pursuant to the CSA. However, manufacturers may submit an application for exemption for those mixtures that do not qualify for automatic exemption.
The Drug Enforcement Administration places seven fentanyl- related substances, as identified in this final rule, including their isomers, esters, ethers, salts and salts of isomers, esters and ethers in schedule I of the Controlled Substances Act. 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 these seven specific controlled substances will continue to apply as a result of this action.
The Drug Enforcement Administration issues this temporary order to schedule two benzimidazole-opioids in schedule I of the Controlled Substances Act. DEA bases this action on a finding that placing these substances in schedule I is necessary to avoid imminent hazard to public safety. This order imposes 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 substances.
The Drug Enforcement Administration (DEA) is establishing a specific listing and DEA Controlled Substances Code Number (drug code) for 1-(1,3-benzodioxol-5-yl)-2-(dimethylamino)pentan-1-one (dipentylone; N,N-dimethylpentylone) in schedule I of the Controlled Substances Act (CSA). Although dipentylone is not specifically listed in schedule I of the CSA with its own unique drug code, it is a schedule I controlled substances in the United States because it is a positional isomer of N-ethylpenthylone (controlled August 31, 2018), which is a schedule I hallucinogen. Therefore, DEA is simply amending the schedule I hallucinogenic substances list in its regulations to separately include dipentylone.
The Acting Administrator of the Drug Enforcement Administration (DEA) is issuing this temporary scheduling order to extend the temporary schedule I status of five designer benzodiazepines--clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam. In an order dated July 26, 2023, DEA temporarily placed these five substances in schedule I of the Controlled Substances Act. This temporary order will extend the temporary scheduling of five designer benzodiazepines for one year, or until the permanent scheduling action for these substances is completed, whichever occurs first. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will continue to be imposed 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 five specified controlled substances.
The Drug Enforcement Administration proposes placing clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam and their salts, isomers, and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, as identified in this proposed rule, in schedule I of the Controlled Substances Act. These five substances were temporarily scheduled in an order dated July 26, 2023, and subsequently extended until July 26, 2026, pursuant to an extension published elsewhere in this issue of the Federal Register. This action will also enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. 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, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle these five specific controlled substances.
The Acting Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule seven benzimidazole-opioid substances in schedule I of the Controlled Substances Act. When it is finalized, 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 seven specified substances.
The Drug Enforcement Administration proposes placing 3- methoxyphencyclidine, including its salts, isomers, and salts of isomers, an arylcyclohexylamine hallucinogen, in schedule I of the Controlled Substances Act. This action is proposed to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would 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 with, or possess), or propose to handle 3-methoxyphencyclidine.
The Drug Enforcement Administration proposes placing three fentanyl-related substances, as identified in this proposed rule, in schedule I of the Controlled Substances Act. These three substances fall within the definition of fentanyl-related substances set forth in the February 6, 2018 temporary scheduling order. Through the Temporary Reauthorization and Study of Emergency Scheduling of Fentanyl Analogues Act, which became law on February 6, 2020, Congress extended the temporary control of fentanyl-related substances until May 6, 2021. This temporary order was subsequently extended multiple times, most recently on March 15, 2025, which extended the order until September 30, 2025. 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, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle these three specific controlled substances.