The Drug Enforcement Administration is proposing the control of phenethyl halides as list I chemicals under the Controlled Substances Act (CSA). Phenethyl halides are important to the illicit manufacture of fentanyl, as well as fentanyl analogues, and fentanyl- related substances as they are often used in synthetic routes to manufacture these substances. Further, in the respective synthetic routes in which they are used to manufacture fentanyl, fentanyl analogues, and fentanyl-related substances, various phenethyl halides, such as phenethyl bromide and phenethyl chloride, can be substituted for each other. If finalized, the proposed rule would subject handlers of phenethyl halides to the chemical regulatory provisions of the CSA and its implementing regulations. This proposed rulemaking does not establish a threshold for domestic and international transactions of phenethyl halides. As such, all transactions of phenethyl halides regardless of size or concentration, shall be regulated and would be subject to control under the CSA.
Comments close Aug 10, 2026
The Drug Enforcement Administration proposes placing the substance tianeptine (7-[(3-chloro-6,11-dihydro-6-methyl-5,5- dioxidodibenzo[c,f][1,2]thiazepin-11-yl)amino]heptanoic acid), including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, salts, and salts of isomers, esters, and ethers is possible, in schedule I of the Controlled Substances Act. 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 tianeptine.
Comments close Aug 7, 2026
The Drug Enforcement Administration proposes placing diphenidine (1-(1,2-diphenylethyl)piperidine), 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 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 diphenidine.
Comments close Jun 25, 2026
The Drug Enforcement Administration (DEA) proposes to revoke the exempted status for certain nonnarcotic prescription products that are currently on DEA's Table of Exempted Prescription Products list but whose National Drug Code (NDC) is inactive because they are no longer available and/or the company that applied for the exemption no longer exists. If finalized, these products would be removed from DEA's Table of Exempted Prescription Products list, and they would no longer be considered exempt prescription products under the Controlled Substances Act. This action will not impact exempted prescription products with active NDC numbers.
Comments close Jun 25, 2026
The Drug Enforcement Administration (DEA) proposes to revise existing regulations relating to the management of quotas for schedule I and II controlled substances and the list I chemicals, ephedrine, pseudoephedrine, and phenylpropanolamine, to be utilized by DEA- registered manufacturers. This rule is being proposed to: restructure DEA's manufacturing and procurement quota regulations for more clarity and consistency; clarify which use-specific subcategories for quotas should be used for controlled substances that will be sold domestically and controlled substances that will be exported; and revise the applications for individual manufacturing and procurement quota. The changes are necessary to increase visibility into the controlled substance supply chain by providing DEA with more detailed information allowing the agency to react more precisely in preventing drug shortages; and to ensure that enough of the schedule I and II controlled substances and three list I chemicals can be manufactured to meet estimated scientific, medical, lawful export, and inventory needs. This rule also contains revisions to use gender neutral language and other non-substantive revisions.
Comments close Jul 20, 2026
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.
Comments close Jan 15, 2026
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.
Comments close Jan 12, 2026
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.
Comments close Nov 3, 2025
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.
Comments close Nov 3, 2025
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.
Comments close Aug 25, 2025
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.
Comments close Jul 10, 2025
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.
Comments close Jul 10, 2025
The Drug Enforcement Administration proposes placing the substance 4-fluoroamphetamine (4-FA; 1-(4-fluorophenyl)propan-2-amine), 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. 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 4-fluoroamphetamine.
Comments close Jul 3, 2025
The Drug Enforcement Administration is proposing the control of propionyl chloride as a list I chemical under the Controlled Substances Act (CSA). The Drug Enforcement Administration finds that propionyl chloride is used in the illicit manufacture of the controlled substances fentanyl, fentanyl analogues and fentanyl-related substances, and is important to the manufacture of these substances. In the respective synthetic pathways in which it is used to manufacture those substances, it is a replacement for propionic anhydride, which is currently a list I chemical. If finalized, the proposed rule would subject handlers of propionyl chloride to the chemical regulatory provisions of the CSA and its implementing regulations. This proposed rulemaking does not establish a threshold for domestic and international transactions of propionyl chloride. As such, all transactions of propionyl chloride, regardless of size, shall be regulated. In addition, chemical mixtures containing propionyl chloride are not exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical mixtures containing any quantity of propionyl chloride shall be regulated pursuant to the CSA. Although no automatic exemption is available, manufacturers may submit an application for exemption.
Comments close Jul 3, 2025
In the January 17, 2025, issue of the Federal Register, the Drug Enforcement Administration and the Department of Health and Human Services published two final rules related to the practice of telemedicine, titled "Expansion of Buprenorphine Treatment via Telemedicine Encounter" and "Continuity of Care via Telemedicine for Veterans Affairs Patients." These final rules were scheduled to become final on February 18, 2025. In accordance with the Presidential Memorandum of January 20, 2025, titled "Regulatory Freeze Pending Review," the Drug Enforcement Administration and the Department of Health and Human Services are delaying the effective dates of these two final rules to March 21, 2025, and are soliciting public comments specifically regarding this delayed effective date.
Comments close Feb 28, 2025
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule three 7-hydroxymitragynine-related substances (mitragynine pseudoindoxyl, MGM-15, and MGM-16), 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 with, or possess) or propose to handle these three 7-hydroxymitragynine-related substances.
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule 7-hydroxymitragynine above a specified threshold, including its 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 with, or possess) or propose to handle 7-hydroxymitragynine above a specified threshold.
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule 1-(1-(1-(4-bromophenyl)ethyl)piperidin-4-yl)-5,6-dichloro-1,3-dihydro- 2H-benzo[d]imidazol-2-one (commonly known as 5,6-dichloro brorphine or SR-14968); 5,6-dichloro-1-(1-(4-chlorobenzyl)piperidin-4-yl)-1,3- dihydro-2H-benzo[d]imidazol-2-one (commonly known as 5,6-dichloro desmethylchlorphine or SR-17018); 3-(3-(1-(1-(4- chlorophenyl)ethyl)piperidin-4-yl)-2-oxo-2,3-dihydro-1H- benzo[d]imidazol-1-yl)propanenitrile (commonly known as N-propionitrile chlorphine or cychlorphine); and 8-(1-(4-chlorophenyl)ethyl)-1-phenyl- 1,3,8-triazaspiro[4.5]decan-4-one (commonly known as spirochlorphine or R-6890), 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 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, or possess) or propose to handle these four specific substances.
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule O-desmethyltramadol (other names: O-DSMT; desmetramadol; 3-[(1R,2R)-2- [(dimethylamino)methyl]-1-hydroxycyclohexyl]phenol), including its isomers, esters, ethers, salts, and salts of isomers, esters and ethers, 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 O-DSMT.
On March 16, 2026, the Drug Enforcement Administration published a temporary order placing 8-bromo-1-methyl-6-phenyl-4H- benzo[f][1,2,4]triazolo[4,3-a][1,4]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. DEA published this temporary order that included an invalid chemical name for bromazolam. This document corrects that error, adding the valid chemical name for bromazolam.
The "Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 (the SUPPORT Act)," which became law on October 24, 2018, amended the Controlled Substances Act to expand the conditions a practitioner must meet to provide medication-assisted treatment for opioid use disorder and expand the options available for a physician to be considered a qualifying physician. The SUPPORT Act also allowed a pharmacy to deliver prescribed controlled substances to a practitioner's registered location for the purpose of maintenance or detoxification treatment to be administered under certain conditions by a practitioner. The Drug Enforcement Administration promulgated an interim final rule with request for comments in November 2020 to amend its regulations to make them consistent with the SUPPORT Act and implement its requirements. On December 29, 2022, the Restoring Hope for Mental Health and Well-Being Act of 2022 removed many of the statutory provisions of the SUPPORT Act. This final rule adopts the provisions of the interim final rule that are still applicable as final, with minor changes. In addition, this final rule implements the related provisions of the Restoring Hope for Mental Health and Well-Being Act of 2022.
The Drug Enforcement Administration (DEA) issues this 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. DEA bases this action on a finding that placing 2-fluorodeschloroketamine in schedule I is necessary to avoid an 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 this substance.
With the issuance of this final rule, the Drug Enforcement Administration places 5-pentyl-2-(2-phenylpropan-2-yl)pyrido[4,3- b]indol-1-one (other names: CUMYL-PEGACLONE; SGT-151), 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. This action imposes 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 Drug Enforcement Administration (DEA) is establishing a specific listing and DEA Controlled Substances Code Number (drug code) for 6,6,9-trimethyl-3-pentyl-6a,7,8,9,10,10a-hexahydro-6H- benzo[c]chromen-1-ol (also known as hexahydrocannabinol, and HHC) in schedule I of the Controlled Substances Act (CSA). Although hexahydrocannabinol 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 under drug code 7370 because it meets the definition of tetrahydrocannabinols, a schedule I hallucinogen. Therefore, DEA is simply amending the schedule I hallucinogenic substances list to separately include hexahydrocannabinol.
With the issuance of this final rule, the Drug Enforcement Administration places methyl 2-[[1-(4-fluorobutyl)indole-3- carbonyl]amino]-3,3-dimethyl-butanoate (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, 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 imposes 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 Department of Justice published a notice of proposed rulemaking in the Federal Register on May 21, 2024, which proposed to transfer marijuana from schedule I of the Controlled Substances Act to schedule III. The Drug Enforcement Administration ("DEA") published a notice of hearing on the proposed rule in the Federal Register on August 29, 2024. Upon further review, DEA is withdrawing the notice of hearing and terminating the pending hearing proceedings. As directed by Executive Order 14370, DEA has determined that the most expeditious manner of completing the rulemaking process in accordance with Federal law is to terminate the pending hearing proceedings and initiate new hearing proceedings. DEA is publishing a new notice of hearing elsewhere in this issue of the Federal Register.
This is notice that the Drug Enforcement Administration ("DEA") will hold a hearing with respect to the proposed rescheduling of marijuana into schedule III of the Controlled Substances Act beginning June 29, 2026. The proposed rescheduling of marijuana was initially proposed in a Notice of Proposed Rulemaking published in the Federal Register on May 21, 2024. In accordance with Executive Order 14370, DEA is completing this process in the most expeditious manner in accordance with Federal law.
With the issuance of this final rule, which constitutes a final order, the Acting Attorney General of the U.S. Department of Justice places drug products containing marijuana that have been approved by the Food and Drug Administration (FDA) in schedule III of the Controlled Substances Act ("CSA"). This action is required to satisfy the responsibility of the Administrator under the CSA to place a drug in the schedule he deems most appropriate to carry out United States obligations under the Single Convention on Narcotic Drugs, 1961. In general, this final rule applies to marijuana as defined in the CSA, marijuana extracts, and delta-9-tetrahydrocannabinol and other compounds derived from the marijuana plant (other than the mature stalks and seeds) that falls outside the definition of hemp, to the extent that any of these are included in an FDA-approved drug product or are subject to a state-issued license to manufacture, distribute, and/or dispense marijuana or products containing marijuana for medical purposes ("state medical marijuana license"). Also consistent therewith, this final rule adds such drugs to the list of substances that may only be imported or exported pursuant to a permit. This final rule also establishes an expedited registration process under 21 CFR part 1301 for entities holding state medical marijuana licenses, enabling such entities to engage in the manufacture, distribution, and/or dispensing of marijuana for medical purposes under federal law consistent with the requirements of the Single Convention.
With the issuance of this final rule, the Drug Enforcement Administration places 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. This action imposes 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 MDMB-4en-PINACA.
The Drug Enforcement Administration is finalizing the control of 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 used in the illicit manufacture of the controlled substances phenylacetone (also known as phenyl-2-propanone or P2P), methamphetamine, and amphetamine, and it is important to the manufacture of these substances. This final rule subjects handlers of P2P methyl glycidic acid to the chemical regulatory provisions of the CSA and its implementing regulations.
Abstract not supplied.
With the issuance of this final rule, the Drug Enforcement Administration places substance 3-methoxyphencyclidine (1-(1-(3- methoxyphenyl)cyclohexyl)piperidine; 3-MeO-PCP), 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 3-MeO-PCP.
On September 30, 2019, the Drug Enforcement Administration (DEA) published the final rule, New Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222). The final rule implemented a new single sheet format for DEA Form 222 and provided for a two-year transition period to switch from the triplicate form. This technical amendment corrects certain regulations erroneously not amended in the final rule which creates ambiguities. The amendment clarifies that a DEA Form 222 Power of Attorney may only be executed or revoked by a registrant, a partner of the registrant, or an officer of a registrant corporate entity. It resolves ambiguity over who may sign a DEA Form 222 and removes the obsolete transition provision for the triplicate version of DEA Form 222. These are conforming revisions that do not make any substantive changes to the regulations.
The Drug Enforcement Administration issues this 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. DEA bases this action on a finding that placing bromazolam in schedule I is necessary to avoid an 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 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 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 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 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.
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.
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 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.
On March 15, 2024, the Drug Enforcement Administration published a final order placing 1-(2-methyl-4-(3-phenylprop-2-en-1- yl)piperazin-1-yl)butan-1-one (commonly known as 2-methyl AP-237), including its optical and geometric isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, in schedule I of the Controlled Substances Act. The effective date of that final order was 30 days after publication in the Federal Register. Before the effective date, DEA published another final order that made the instructions for 2-methyl AP-237 in the March 15 final order invalid. This document corrects that error, adding 2- methyl AP-237 and its drug code 9664 for regulatory purposes.
In the January 17, 2025, issue of the Federal Register, the Drug Enforcement Administration and the Department of Health and Human Services published two final rules related to the practice of telemedicine, titled "Expansion of Buprenorphine Treatment via Telemedicine Encounter" and "Continuity of Care via Telemedicine for Veterans Affairs Patients." These final rules were originally scheduled to become final on February 18, 2025. In accordance with the Presidential Memorandum of January 20, 2025, titled "Regulatory Freeze Pending Review," the Drug Enforcement Administration and the Department of Health and Human Services delayed the effective dates of these two final rules to March 21, 2025, by issuing a final rule; delay of effective dates and request for comments in the February 19, 2025, issue of the Federal Register. The Drug Enforcement Administration received 32 comments in response to the request for public comments regarding the delayed effective date. Considering these comments, the Department of Justice wishes to further postpone the effective dates for the purpose of further reviewing any questions of fact, law, and policy that the rules may raise. Therefore, the Drug Enforcement Administration and the Department of Health and Human Services will delay the effective date of the two final rules titled "Expansion of Buprenorphine Treatment via Telemedicine Encounter" and "Continuity of Care via Telemedicine for Veterans Affairs Patients" to December 31, 2025.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the "Ryan Haight Act") generally requires an in-person medical evaluation prior to the issuance of a prescription of controlled substances but provides an exception to this in-person medical evaluation requirement where the practitioner is engaged in the "practice of telemedicine" within the meaning of the Ryan Haight Act. These proposed regulatory changes would establish a Special Registration framework and authorize three types of Special Registration. This proposed rulemaking also provides for heightened prescription, recordkeeping, and reporting requirements. DEA believes such changes are necessary to effectively expand patient access to controlled substance medications via telemedicine while mitigating the risks of diversion associated with such expansion. A summary of this rule may be found at https://www.regulations.gov/docket/DEA-2023-0029.
The Drug Enforcement Administration and the Department of Health and Human Services are amending their regulations to expand the circumstances under which practitioners registered by the Drug Enforcement Administration are authorized to prescribe schedule III-V controlled substances approved by the Food and Drug Administration for the treatment of opioid use disorder via a telemedicine encounter, including an audio-only telemedicine encounter. Under these new regulations, after a practitioner reviews the patient's prescription drug monitoring program data for the state in which the patient is located during the telemedicine encounter, the practitioner may prescribe an initial six-month supply of such medications (split amongst several prescriptions totaling six calendar months) through audio-only means. Additional prescriptions can be issued under other forms of telemedicine as authorized under the Controlled Substances Act, or after an in-person medical evaluation is conducted. This regulation also requires the pharmacist to verify the identity of the patient prior to filling a prescription. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 generally requires an in- person medical evaluation prior to issuance of a controlled substance prescription. However, this regulation falls under one of the exceptions found within the Ryan Haight Act. Additionally, this regulation does not affect practitioner-patient relationships in cases where an in-person medical evaluation has previously occurred. The purpose of this regulation is to prevent lapses of care by continuing some of the telemedicine flexibilities that currently exist for those patients seeking treatment for opioid use disorder.
This final rule authorizes Department of Veterans Affairs (VA) practitioners acting within the scope of their VA employment to prescribe controlled substances via telemedicine to a VA patient with whom they have not conducted an in-person medical evaluation. VA practitioners are permitted to prescribe controlled substances to VA patients if another VA practitioner has, at any time, previously conducted an in-person medical evaluation of the VA patient, subject to certain conditions.
