Pharma Services Seeks Approval to Import Controlled Substances

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: 2025-13450, Submission for OMB Review; Comment Request

The Department of Agriculture wants your thoughts on a new info collection about dairy markets to help farmers and buyers get better prices and balance supply and demand. If you’re involved in dairy or agriculture, this could affect you! Comments are open until August 18, 2025, and the goal is to keep things clear and easy without costing extra time or money.

Next: 2025-13452, Bulk Manufacturer of Controlled Substances Curia New York, Inc.

Curia New York, Inc. wants to become an official bulk maker of certain controlled drugs. This means they’ll be allowed to produce large amounts of these substances legally. If approved, this could impact companies and regulators by adding a new player in the drug manufacturing scene, with no immediate cost or deadline changes announced.