Pharma Firm Seeks Approval to Produce Bulk Controlled Drugs
Published Date: 3/17/2025
Notice
Summary
Sterling Pharma USA LLC wants to get official approval to make large amounts of certain controlled drugs. This affects anyone involved in drug manufacturing and regulation, as it could change who supplies these substances. Keep an eye out for updates, as this could impact drug availability and industry rules soon.
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.
2026-12143 — Importer of Controlled Substances Application: AndersonBrecon, Inc. DBA PCI Pharma Services
AndersonBrecon, Inc. DBA PCI Pharma Services wants to become an official importer of certain controlled substances, including some strong drugs like tetrahydrocannabinols. People and companies involved with these drugs can share their thoughts or ask for a hearing by July 17, 2026. This move could impact how these substances are brought into the U.S., but no costs or fees were mentioned yet.
2026-12140 — Importer of Controlled Substances Application: Scottsdale Research Institute
Scottsdale Research Institute wants to become an official importer of some controlled substances like ibogaine and marijuana. People who make or import these drugs can share their thoughts or ask for a hearing by July 17, 2026. This move could affect how these substances are brought into the U.S., but no costs or fees are mentioned yet.
2026-12144 — Importer of Controlled Substances Application: Wedgewood Pharmacy LLC
Wedgewood Pharmacy LLC wants to become an official importer of certain strong controlled substances, like Etorphine HCL and Thiafentanil. This affects drug manufacturers and others in the supply chain who can comment or request a hearing by July 17, 2026. No direct costs are mentioned, but the decision could impact how these drugs enter the U.S. market.
2026-11909 — Importer of Controlled Substances Application: Cerilliant Corporation
Cerilliant Corporation wants to become an official importer of certain controlled substances, including some drugs that need strict government oversight. People and companies involved with these substances can share their thoughts or ask for a hearing by July 15, 2026. This move could affect how these drugs enter the U.S. and might impact businesses handling them.
Previous / Next Documents
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!