Pharma Firm Seeks Bulk GHB Okay for Legit Medicines
Published Date: 5/4/2026
Notice
Summary
Patheon Pharmaceuticals wants to make a big batch of a controlled drug called Gamma Hydroxybutyric Acid (GHB) to help create FDA-approved medicines. People and companies involved with controlled substances can share their thoughts or ask for a hearing by July 6, 2026. This move could speed up medicine production but also means careful government checks and rules.
No Economic Impacts Identified for this Document
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions 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.
2026-13364 — 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
Starting July 1, 2026, the DEA is temporarily putting four new substances—5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N-propionitrile chlorphine, and spirochlorphine—into Schedule I, the strictest drug category. This means anyone making, selling, or using these chemicals will face tough legal rules and penalties. The move helps keep these potentially dangerous drugs off the streets while the DEA studies them further.
2026-13145 — Importer of Controlled Substances Application: Almac Clinical Services Incorp. (ACSI)
Almac Clinical Services Incorp. (ACSI) wants to become an official importer of certain controlled substances, including psilocybin and oxycodone. This affects drug manufacturers and others in the industry who can comment or request a hearing by July 30, 2026. No direct costs are mentioned, but the decision could impact how these substances enter the U.S. market.
2026-13144 — Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC
Catalent Pharma Solutions wants to become an official importer of some powerful controlled substances like LSD and psilocybin. People who make or use these drugs can share their thoughts or ask for a hearing by July 30, 2026. This move could impact companies involved in these substances and the government’s control over them.
2026-12653 — Schedules of Controlled Substances: Placement of Bromazolam in Schedule I; Correction
The DEA fixed a typo in the official chemical name of bromazolam, a drug they put in the strictest Schedule I category starting March 16, 2026. This correction makes the rules clear for everyone involved, especially law enforcement and drug handlers. No new fees or deadlines, just a clean-up to keep things accurate and official.
Previous / Next Documents
Previous: 2026-08584 — Submission for Office of Management and Budget Review; Safe Access for Victims' Economic Security, Data Collection for Safety in Child Support Program Research (New Collection)
The government is gathering info to make child support programs safer for domestic violence survivors. They’ll talk to survivors, advocates, and child support workers to find out what works and what doesn’t. This effort affects 12 states and one tribal area, with public comments open until June 3, 2026, and aims to improve safety without extra costs to the public.
Next: 2026-08586 — Bulk Manufacturer of Controlled Substances Application: ANI Pharmaceuticals Inc.
ANI Pharmaceuticals wants to make a big batch of a strong medicine called Levorphanol, which is a controlled substance. This affects people in the drug manufacturing and regulation world, and the public can share their thoughts or ask for a hearing by July 6, 2026. If approved, ANI will help develop new medicines, but no other activities with this drug are allowed under this registration.