Aphena Pharma Wants Green Light for Controlled Substance Imports
Published Date: 3/6/2025
Notice
Summary
Aphena Pharma Solutions MD, LLC wants to get official permission to import certain controlled drugs. This affects anyone involved in drug import rules and could change how these medicines come into the U.S. No big money or timing changes are mentioned yet, but keep an eye out for updates!
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.
2026-10380 — Schedules of Controlled Substances: Placement of Diphenidine in Schedule I
The DEA wants to put diphenidine, a drug, into Schedule I, which means it will be treated like the most tightly controlled substances. This change affects anyone who makes, sells, studies, or owns diphenidine, adding strict rules and penalties. You’ve got until June 25, 2026, to share your thoughts before the new rules might kick in.
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.
2026-08588 — 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: 2025-03635 — Importer of Controlled Substances Application: Indivior Inc.
Indivior Inc. wants to become an official importer of certain controlled substances. This means they’ll be allowed to bring in specific drugs that are carefully regulated. If approved, it could affect companies and regulators keeping an eye on drug imports, with no immediate cost changes announced.
Next: 2025-03637 — National Council on the Arts 215th Meeting
The National Council on the Arts is holding its 215th meeting online, open for everyone to watch. Some parts will be private to discuss sensitive topics. This meeting affects artists, arts groups, and anyone interested in arts funding and decisions happening soon.