DEA Okays Bulk GHB Production for Sleep Disorder Pills?
Published Date: 3/13/2025
Notice
Summary
Patheon Pharmaceuticals wants to make a special controlled drug called Gamma Hydroxybutyric Acid in large amounts. If approved, they’ll produce it as a key ingredient for FDA-approved medicines. People can share their thoughts or ask for a hearing by May 12, 2025, so keep an eye on that deadline!
No Economic Impacts Identified for this Document
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.
2025-05007, Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients
Starting December 31, 2025, veterans can get buprenorphine treatment and follow-up care through telemedicine, making it easier to access help for opioid use disorder without leaving home. This change affects veterans using VA health services and aims to improve treatment access while the government reviews feedback and policies. No new costs are mentioned, but the delay gives agencies time to ensure the rules work well.
2025-02793, Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients
The government is giving veterans easier access to buprenorphine treatment through telemedicine, letting them get care remotely. This change affects veterans using VA health services and aims to make treatment smoother and more convenient. The new rules were supposed to start February 18, 2025, but now they’ll kick in on March 21, 2025, while the government gathers public feedback.
2026-20226, By Grace Inc. Counseling Services; Decision and Order
By Grace Inc. Counseling Services in Baltimore faced losing its DEA license because it didn’t keep good records and lied about its owner’s past drug conviction. After a hearing, the DEA decided to revoke their registration, meaning they can’t legally handle controlled substances anymore. This affects the clinic’s ability to operate and could impact patients relying on their services.
2026-20227, St. Michael's Pharmacy; Decision and Order
St. Michael's Pharmacy in Texas had its DEA license suspended and is facing revocation because it kept filling risky drug prescriptions without fixing obvious warning signs of abuse. This affects the pharmacy’s ability to legally handle controlled substances and could impact patients relying on it. The pharmacy must now deal with these serious legal actions, which started in late 2025 and could lead to permanent closure or fines.
Previous / Next Documents
Previous: 2025-04044, Bulk Manufacturer of Controlled Substances Application: Sigma Aldrich Research Biochemicals Inc.
Sigma Aldrich Research Biochemicals Inc. wants to become a big-time maker of certain controlled substances, including some well-known drugs like LSD and THC. People and companies involved with these substances can share their thoughts or ask for a hearing by May 12, 2025. This move could impact how these drugs are produced and regulated, but no direct costs are mentioned yet.
Next: 2025-04046, Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Fisher Clinical Services, Inc. wants to become an official importer of certain controlled substances like marijuana and related compounds. People and companies already registered can comment or object by April 14, 2025, and even request a hearing. This move could impact businesses dealing with these substances and involves a formal review process with deadlines to keep in mind.