DEA Reviews Patheon API's Controlled Substances Import Application
Published Date: 5/20/2025
Notice
Summary
Patheon API Inc. wants to get official approval to import certain controlled substances. This means they’ll be able to bring in specific drugs that need special handling. If approved, it could affect companies and regulators by adding a new player in the controlled substances import game, with timing and money details to follow.
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
2026-10128 — 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.
2026-10253 — Schedules of Controlled Substances: Temporary Placement of 2-Fluorodeschloroketamine in Schedule I
Starting May 22, 2026, the DEA is putting 2-fluorodeschloroketamine (2-FDCK) into Schedule I, meaning it’s now treated like the most dangerous drugs. This affects anyone who makes, sells, or uses it, adding strict rules and serious penalties. The temporary ban lasts two years, giving the government time to decide if it should stay permanent.
2026-10090 — Exempt Chemical Preparations Under the Controlled Substances Act
The Drug Enforcement Administration (DEA) reviewed and decided on applications for special chemical mixtures that don’t fall under strict drug rules, covering requests from July 2025 to March 2026. Some mixtures got approved, others denied, and a few listings were fixed from earlier notices. If you’re involved with these chemicals, you’ve got until July 20, 2026, to share your thoughts—no fees or big costs involved, just your voice!
2026-09566 — Schedules of Controlled Substances: Placement of CUMYL-PEGACLONE in Schedule I
Starting May 13, 2026, the DEA officially puts CUMYL-PEGACLONE—a chemical that can be risky—into Schedule I, the strictest drug category. This means anyone making, selling, or using it now faces tough rules and penalties. This move helps the U.S. follow international drug laws and keeps communities safer without any new fees or costs.
2026-08587 — Importer of Controlled Substances Application: ANI Pharmaceuticals Inc.
ANI Pharmaceuticals wants to import certain controlled drugs like Levorphanol and Tapentadol. People who make or use these drugs can share their thoughts or ask for a hearing by June 3, 2026. This move could affect drug availability and regulation, so keep an eye on the deadline to have your say!
2026-08588 — Bulk Manufacturer of Controlled Substances Application: Patheon API Inc.
Patheon API Inc. wants to make large amounts of special research drugs like dimethyltryptamine and psilocybin. This affects researchers and companies involved in clinical trials, with a chance to comment or ask for a hearing by July 6, 2026. No money changes are mentioned, but this move could speed up important medical studies.
Previous / Next Documents
Previous: 2025-08987 — Ferrosilicon From Kazakhstan: Amended Final Countervailing Duty Determination; Ferrosilicon From Brazil, Kazakhstan, and Malaysia: Countervailing Duty Orders
The U.S. is putting special taxes on ferrosilicon imports from Brazil, Kazakhstan, and Malaysia to keep things fair for American businesses. They also fixed a small mistake in the Kazakhstan tax decision. These changes mean importers will need to pay extra fees starting now, helping U.S. producers compete better.
Next: 2025-08991 — Open Meeting of the Taxpayer Advocacy Panel's Special Projects Committee
The Taxpayer Advocacy Panel's Special Projects Committee is holding a virtual meeting to gather ideas from the public on how to make the IRS better and easier to use. If you pay taxes or help others with taxes, your input can help shape improvements. The meeting is online, so anyone interested can join and share their thoughts without leaving home!