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2026-10-19 · Notice

Bulk Manufacturer of Controlled Substances Application: National Center for Natural Products Research University of Mississippi/NCNPR

Justice Department, Drug Enforcement Administration

Official abstract: National Center for Natural Products Research University of Mississippi/NCNPR 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.

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2026-10-14 · Proposed Rule

Schedules of Controlled Substances: Temporary Placement of 7- Hydroxymitragynine and Mitragynine Pseudoindoxyl Above a Specified Threshold in Schedule I

Justice Department, Drug Enforcement Administration

Official abstract: The Administrator of the Drug Enforcement Administration (DEA) is issuing this notice of intent to publish a temporary order to schedule 7-hydroxymitragynine and mitragynine pseudoindoxyl (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) when either substance alone, or their combined amount if both are present, is above a specified threshold, in schedule I of the Controlled Substances Act (CSA). Based on a different threshold provided by the Department of Health and Human Services (HHS) in July of 2025, DEA published a notice of intent to temporarily schedule 7-hydroxymitragynine above that lower threshold on July 7, 2026. Additionally, DEA published a temporary order placing mitragynine pseudoindoxyl without a threshold in schedule I of the CSA on August 26, 2026. On October 8, 2026, HHS sent a letter recommending that DEA place of the CSA 7-hydroxymitragynine and mitragynine pseudoindoxyl in schedule I when either substance alone, or their combined amount if both are present, is above a new specified threshold. Based on the October 8, 2026 letter, DEA is issuing this notice of intent. While the new threshold recommended by HHS would permit certain products to remain in the marketplace without being subject to schedule I controls, neither HHS nor DEA has made a finding that these substances are safe to use at below-threshold levels. When a temporary order is issued, it 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 and/or mitragynine pseudoindoxyl above the specified threshold. In a separate document contained in this issue of the Federal Register, DEA is withdrawing the July 7, 2026 notice of intent related to 7-hydroxymitragynine. The August 26, 2026 temporary order placing mitragynine pseudoindoxyl in schedule I of the CSA without a threshold remains in effect until either it expires or the new temporary order is published and the previous order is withdrawn, whichever occurs first.

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2026-10-14 · Proposed Rule

Schedules of Controlled Substances: Temporary Placement of MGM-15 and MGM-16 in Schedule I

Justice Department, Drug Enforcement Administration

Official abstract: The Drug Enforcement Administration (DEA) is issuing this notice of intent to publish a temporary order to schedule two 7- hydroxymitragynine-related substances (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 (CSA). On August 26, 2026, DEA published a temporary order placing mitragynine pseudoindoxyl, MGM-15, and MGM-16 in schedule I of the CSA. Today, DEA is providing notice of its intent to publish a new temporary order for MGM-15 and MGM-16 that will maintain the temporary placement of these substances in schedule I of the CSA without change. Separately in this Federal Register, DEA is publishing a notice of intent relating to mitragynine pseudoindoxyl, in response to a letter sent by the Department of Health and Human Services (HHS) dated October 6, 2026. HHS's letter related only to mitragynine pseudoindoxyl. Therefore, DEA is publishing this notice of intent only for the technical and procedural purpose of distinguishing MGM-15 and MGM-16 from mitragynine pseudoindoxyl. When issued, the temporary scheduling order addressing MGM-15 and MGM-16 will continue to 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 two 7-hydroxymitragynine-related substances. The August 26, 2026 temporary order placing these substances in schedule I of the CSA remains in effect until either it expires or the new temporary order is published and the previous order is withdrawn, whichever occurs first.

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2026-10-09 · Rule

Schedules of Controlled Substances; Removal of Exemption Status for Inactive Butalbital Products

Justice Department, Drug Enforcement Administration

Official abstract: The Drug Enforcement Administration (DEA) is revoking the exempted status for certain nonnarcotic prescription products that are currently on DEA's Table of Exempted Prescription Products, but whose National Drug Codes (NDC) are inactive because they are no longer available and/or the company that applied for the exemption no longer exists. These products will be removed from DEA's Table of Exempted Prescription Products and will no longer be considered exempt prescription products under the Controlled Substances Act. This action does not impact exempted prescription products with active NDC numbers.

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2026-10-09 · Rule

Schedules of Controlled Substances: Placement of O-Desmethyltramadol in Schedule I; Correction

Justice Department, Drug Enforcement Administration

Official abstract: On August 12, 2026, the Drug Enforcement Administration (DEA) published a temporary order placing O-desmethyltramadol (other names: O-DSMT; desmetramadol; 3-[(1R,2R)-2-[(dimethylamino)methyl]-1- hydroxycyclohexyl]phenol), 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 specifically noted in the summary that the control of O-desmethyltramadol included its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers are possible, however inadvertently omitted the correct language that should have been included. This document corrects that error, adding the correct language.

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2026-10-01 · Proposed Rule

Extension of Reexportation Period.

Justice Department, Drug Enforcement Administration

Official abstract: This proposed rule would amend the regulations of the Drug Enforcement Administration (DEA) to extend the time allowed for reexports of controlled substances outside of the European Economic Area from 180 days from the date of original release from U.S. Customs and Border Protection to 365 days from that original release date.

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2026-09-23 · Proposed Rule

Schedules of Controlled Substances: Placement of 4-Hydroxy-N,N-Diisopropyltryptamine (4-OH-DiPT), 5-Methoxy-alpha-Methyltryptamine (5-MeO-AMT), 5-Methoxy-N-Methyl-N-Isopropyltryptamine (5-MeO-MiPT), 5-Methoxy-N,N-Diethyltryptamine (5-MeO-DET), and N,N-Diisopropyltryptamine (DiPT) Into Schedule I

Justice Department, Drug Enforcement Administration

Official abstract: The Drug Enforcement Administration proposes placing five tryptamine hallucinogens, 4-hydroxy-N,N-diisopropyltryptamine (other names: 4-OH-DiPT; 3-(2-(diisopropylamino)ethyl)-1H-indol-4- ol), 5-methoxy-alpha-methyltryptamine (other names: 5-MeO-AMT; 1-(5- methoxy-1H-indol-3-yl)propan-2-amine), 5-methoxy-N-methyl-N- isopropyltryptamine (other names: 5-MeO-MiPT; N-(2-(5-methoxy-1H-indol- 3-yl)ethyl)-N-methylpropan-2-amine), 5-methoxy-N,N-diethyltryptamine (other names: 5-MeO-DET; N,N-diethyl-2-(5-methoxy-1H-indol-3- yl)ethanamine), and N,N-diisopropyltryptamine (other names: DiPT; N-(2- (1H-indol-3-yl)ethyl)-N-isopropylpropan-2-amine), 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. 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 these five specific tryptamine hallucinogens.

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2026-09-21 · Rule

Schedules of Controlled Substances: Placement of Diphenidine in Schedule I

Justice Department, Drug Enforcement Administration

Official abstract: With the issuance of this final rule, the Drug Enforcement Administration places the substance 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. 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 diphenidine.

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2026-08-27 · Rule

Schedules of Controlled Substances: Placement of Cipepofol in Schedule IV

Justice Department, Drug Enforcement Administration

Official abstract: On May 29, 2026, the United States Food and Drug Administration (FDA) approved a new drug application for Cypsedo (cipepofol) for induction of general anesthesia in adults undergoing surgery. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place cipepofol, chemically known as 2-[(1R)-1-cyclopropylethyl]-6- isopropylphenol, in schedule IV of the Controlled Substances Act (CSA). In accordance with the CSA, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing cipepofol in schedule IV of the CSA.

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2026-08-27 · Rule

Schedules of Controlled Substances: Temporary Placement of 5,6-Dichloro Brorphine, 5,6-Dichloro Desmethylchlorphine, N-Propionitrile Chlorphine, and Spirochlorphine in Schedule I of the Controlled Substances Act

Justice Department, Drug Enforcement Administration

Official abstract: The Drug Enforcement Administration (DEA) issues this 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, to schedule I under the Controlled Substances Act. DEA bases this action on a finding that placing 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N- propionitrile chlorphine, and spirochlorphine 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.

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2026-08-26 · Rule

Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I

Justice Department, Drug Enforcement Administration

Official abstract: The Drug Enforcement Administration (DEA) is issuing this 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. DEA bases this action on a finding that placing mitragynine pseudoindoxyl, MGM-15, and MGM-16 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 with, or possess) or propose to handle these three 7-hydroxymitragynine-related substances.

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2026-08-25 · Notice

Bulk Manufacturer of Controlled Substances Application: Scottsdale Research Institute SRI Montana Satellite Laboratory

Justice Department, Drug Enforcement Administration

Official abstract: Scottsdale Research Institute SRI Montana Satellite Laboratory 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.

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2026-08-14 · Notice

Exempt Chemical Preparations Under the Controlled Substances Act

Justice Department, Drug Enforcement Administration

Official abstract: The applications for exempt chemical preparations received by the Drug Enforcement Administration between March 1, 2026, and June 30, 2026, as listed below, were accepted for filing and have been approved or denied as indicated. This publication addresses preparations through June 30, 2026, that were not included in previous Federal Register notices, and it does not affect preparations that have been previously published.

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2026-08-12 · Rule

Schedules of Controlled Substances: Temporary Placement of O-Desmethyltramadol in Schedule I

Justice Department, Drug Enforcement Administration

Official abstract: The Drug Enforcement Administration issues this 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. DEA bases this action on a finding that placing O-DSMT 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 with, or possess) or propose to handle O-DSMT.

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2026-08-11 · Proposed Rule

Schedules of Controlled Substances: Rescheduling of Suvorexant, Lemborexant, and Daridorexant From Schedule IV Into Schedule V

Justice Department, Drug Enforcement Administration

Official abstract: The Drug Enforcement Administration proposes to transfer suvorexant ([(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4- diazepan-1-yl]-[5-methyl-2-(triazol-2-yl)phenyl]methanone), lemborexant ((1R,2S)-2-[(2,4-dimethylpyrimidin-5-yl)oxymethyl]-2-(3-fluorophenyl)- N-(5-fluoropyridin-2-yl)cyclopropane-1-carboxamide), and daridorexant ([(2S)-2-(5-chloro-4-methyl-1H-benzimidazol-2-yl)-2-methylpyrrolidin-1- yl]-[5-methoxy-2-(triazol-2-yl)phenyl]methanone) from schedule IV to schedule V of the Controlled Substances Act. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule V 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 suvorexant, lemborexant, and daridorexant.

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2026-08-03 · Proposed Rule

Amendment to 3,4-MDP-2-P Methyl Glycidic Acid, a List I Chemical

Justice Department, Drug Enforcement Administration

Official abstract: The Drug Enforcement Administration is proposing to modify the listing of the list I chemical 3,4-MDP-2-P methyl glycidic acid (also known as PMK glycidic acid) to include esters of 3,4-MDP-2-P methyl glycidic acid, not listed elsewhere in the Controlled Substances Act (CSA), as list I chemicals under the CSA. The current listing of 3,4- MDP-2-P methyl glycidic acid includes its salts, optical and geometric isomers, and salts of isomers. DEA proposes the new listing to read as follows: 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) and its esters, not listed elsewhere in the CSA, its optical and geometric isomers, its salts, salts of its optical and geometric isomers, salts of its esters, not listed elsewhere in the CSA, and any combination thereof, whenever the existence of such is possible.

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