DEA Approves Health Firm's Bid to Import Controlled Drugs
Published Date: 12/19/2025
Notice
Summary
Groff Health Inc. wants to become an official importer of some powerful controlled substances like psilocybin and psilocyn. People and companies involved with these drugs can share their thoughts or ask for a hearing by January 20, 2026. This move could shake up the market and rules around importing these substances, so keep an eye on the deadline!
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Import Limited to Bulk, Not Finished Drugs
The application states imports would be for bulk substances to support internal research, clinical trials, analytical purposes, and distribution to customers. The registration would not authorize import of FDA-approved or non-approved finished dosage forms for commercial sale.
Application to Import Psilocybin and Psilocyn
Groff Health Inc. applied on November 7, 2025 to be registered as an importer for psilocybin (drug code 7437) and psilocyn (drug code 7438), both listed in Schedule I. If approved, the company could import those bulk controlled substances under that registration.
Comment and Hearing Deadline Jan 20, 2026
Registered bulk manufacturers of the affected drug classes and other applicants may submit electronic comments or objections, or file a written request for a hearing, on or before January 20, 2026. Comments must be submitted through https://www.regulations.gov and hearing requests have specified mailing addresses to the DEA.
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: 2025-23463 — Name of Information Collection: Astronaut's System for Tracking and Requesting Appearances (ASTRA)
NASA is bringing back and updating its Astronaut Appearance system, called ASTRA, which helps schools, groups, and businesses easily book astronauts for in-person, virtual, or recorded visits. This change aims to make the process smoother and less paperwork-heavy for everyone involved. If you want to share your thoughts, be sure to comment by January 20, 2026!
Next: 2025-23467 — Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals, Inc.
Janssen Pharmaceuticals wants to make a lot of methylphenidate, a controlled drug used to treat conditions like ADHD. They’ve applied to get official permission to do this, and anyone who has concerns can speak up by February 17, 2026. This move affects drug makers and buyers and could impact the supply of this medicine.