Pharma Firm Seeks Approval to Produce Bulk Controlled Drugs

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.

2026-17531, 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

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.

2026-17429, Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I

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.

2026-17385, Importer of Controlled Substances Application: Experic LLC

Experic LLC wants to become an official importer of some controlled substances, including certain drugs like tetrahydrocannabinols and nabilone. People and companies already registered can share their thoughts or ask for a hearing by September 25, 2026. This move could impact businesses dealing with these substances, so keep an eye on the deadline to have your say!

2026-17276, Importer of Controlled Substances Application: Biopharmaceutical Research Company

Biopharmaceutical Research Company has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

Previous: 2025-04283, North Pacific Fishery Management Council; Public Meeting

The North Pacific Fishery Management Council’s Crab Plan Team is meeting from May 12-15, 2025 to talk about managing crab fishing in the Bering Sea and Aleutian Islands. This affects crab fishermen, seafood businesses, and communities relying on crab fishing. They’ll discuss important rules and plans that could change how crab fishing works and impact the crab market and local jobs.

Next: 2025-04285, Importer of Controlled Substance Application: Fisher Clinical Services, Inc.

Fisher Clinical Services, Inc. wants to get official approval to bring in certain controlled substances into the U.S. This means they’ll be able to import these drugs legally, which could speed up medical research and treatments. Keep an eye out for any updates or deadlines related to their application process!