DEA Schedules Two Potent Synthetic Opioids in Strictest Ban Category
Published Date: 12/23/2025
Rule
Summary
Starting January 22, 2026, two powerful drugs called N-desethyl isotonitazene and N-piperidinyl etonitazene will be officially banned and placed in the toughest drug category, Schedule I. This means anyone making, selling, or using these drugs will face serious legal trouble. This move helps the U.S. follow international drug rules and keeps communities safer without adding new costs.
Analyzed Economic Effects
3 provisions identified: 0 benefits, 3 costs, 0 mixed.
Manufacturers and Distributors Face Schedule I Controls
Starting January 22, 2026, manufacturers, distributors, importers, and exporters of N-desethyl isotonitazene and N-piperidinyl etonitazene must be registered with the DEA and follow Schedule I rules. That includes following 21 U.S.C. registration and quota rules, keeping inventories (initial inventory and new inventories every two years), meeting security and labeling rules, submitting reports to the Automation of Reports and Consolidated Order System, and obeying order-form, import/export, and disposal rules; violations may bring administrative, civil, or criminal penalties.
Researchers and Instructional Users Must Register
From January 22, 2026, anyone who engages in research or instructional activities with these two substances must register with DEA and follow Schedule I requirements such as security screening, labeling and packaging rules, disposal under 21 CFR part 1317, and recordkeeping and reporting obligations. All research or instructional use is subject to the same inventory, security, and reporting rules that apply to Schedule I controlled substances.
Possession or Retail Sales Will Be Unlawful
Effective January 22, 2026, possession of any quantity of N-desethyl isotonitazene or N-piperidinyl etonitazene without DEA authorization is unlawful and may lead to prosecution, and retail sales of Schedule I substances to the general public are not allowed under the Controlled Substances Act. Unauthorized activities involving these substances may result in administrative, civil, and criminal sanctions.
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: 2025-23685, Safety Zone; West of Cyril E. King Airport, St. Thomas, VI
Starting January 1, 2026, the Coast Guard is setting up a temporary safety zone in the waters west of Cyril E. King Airport in St. Thomas to keep boats and people safe from low-flying planes. No one can enter this zone without special permission until March 31, 2026. This rule helps prevent accidents and protects the environment, with no extra costs for the public.
Next: 2025-23738, Amendment of Colored Federal Airway Green 8, Jet Route J-115, United States Area Navigation (RNAV) Route T-227 and Establishment of RNAV Route Q-188 in Alaska; Correction
The FAA fixed some mix-ups in their recent Alaska flight route updates involving Green 8, Jet Route J-115, and RNAV Route T-227, plus the new RNAV Route Q-188. These changes help pilots navigate better after the Shemya radio beacon is retired. The corrected rules kick in January 22, 2026, with no extra costs for airlines or travelers.