DEA Temporarily Bans Two Potent Synthetic Nitazenes in Schedule I
Published Date: 8/15/2025
Rule
Summary
The DEA is temporarily putting two dangerous drugs, N-pyrrolidino metonitazene and N-pyrrolidino protonitazene, into Schedule I to keep everyone safe. This means strict rules and serious penalties now apply to anyone making, selling, or using these drugs. The change kicks in right away to stop harm before it happens.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Schedule I controls and penalties applied
The DEA temporarily placed N-pyrrolidino metonitazene and N-pyrrolidino protonitazene into Schedule I. That means the strict regulatory controls and the administrative, civil, and criminal sanctions that apply to Schedule I substances now apply to anyone who manufactures, distributes, imports, exports, conducts research or instructional activities, performs chemical analysis, reverse distributes, or possesses these drugs.
Immediate action to protect public safety
The DEA says placing N-pyrrolidino metonitazene and N-pyrrolidino protonitazene in Schedule I is necessary "to avoid imminent hazard to public safety," and the temporary scheduling is effective immediately. This action is intended to prevent harms from these two benzimidazole-opioids while the scheduling is in effect.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-11526, Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment
Starting July 9, 2026, new rules make it easier for doctors and pharmacies to provide medicine that helps people recover from opioid addiction. These changes affect healthcare providers by expanding who can give medication-assisted treatment and how pharmacies can deliver these medicines. The goal? Faster, safer access to treatment with clear rules that save time and support recovery.
2026-10128, Revision of Applications for Manufacturing and Procurement Quotas
The DEA wants to update how companies apply for permission to make and buy certain controlled drugs and chemicals. These changes will make the rules clearer, help prevent drug shortages, and ensure enough supply for medical and scientific needs. If you’re a manufacturer or involved in this process, get ready to follow new steps and share your thoughts by July 20, 2026.
2026-16665, Exempt Chemical Preparations Under the Controlled Substances Act
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.
2026-16413, Schedules of Controlled Substances: Temporary Placement of O-Desmethyltramadol in Schedule I
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.
2026-16375, Schedules of Controlled Substances: Rescheduling of Suvorexant, Lemborexant, and Daridorexant From Schedule IV Into Schedule V
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.
2026-15624, Amendment to 3,4-MDP-2-P Methyl Glycidic Acid, a List I Chemical
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.
Previous / Next Documents
Previous: 2025-15565, Interim Enforcement Policy for Enforcement Discretion for General Licensee Adoption of Certificate of Compliance Holder-Generated Changes
The NRC is giving general license holders a break by not punishing certain rule slip-ups when they adopt changes made by the Certificate of Compliance holder. This temporary policy helps licensees adjust without stress while keeping safety in check. It affects anyone using these licenses and could save time and money during this transition period.
Next: 2025-15609, Endangered and Threatened Species; Designation of Critical Habitat for Five Species of Threatened Indo-Pacific Corals; Correction
The National Marine Fisheries Service fixed a small mistake in their July 2025 rule about protecting five threatened Indo-Pacific coral species. They corrected the section numbers that point to important habitat areas, making sure everything matches up perfectly. This update helps keep coral protection clear and on track, with no extra costs or delays.