2025-21179Notice

Importer of Controlled Substances Application: Caligor Coghlan Pharma Services

Published Date: 11/26/2025

Notice

Summary

Caligor Coghlan Pharma Services wants to become an official importer of certain controlled substances, including some powerful drugs like LSD. People and companies involved with these drugs can share their thoughts or ask for a hearing by December 26, 2025. This move could impact how these substances are brought into the U.S., but no costs or fees are mentioned yet.

Analyzed Economic Effects

3 provisions identified: 2 benefits, 1 costs, 0 mixed.

Importer Application for Schedule I Drugs

Caligor Coghlan Pharma Services applied on July 24, 2025 to be registered to import these Schedule I finished dosage units for clinical trials: lysergic acid diethylamide (LSD, code 7315), 5‑Methoxy‑N‑N‑dimethyltryptamine (code 7431), dimethyltryptamine (DMT, code 7435), and psilocyn (code 7438). The company plans to import finished dosage units for use in clinical trials only, subject to approval under 21 U.S.C. 952(a)(2).

No Commercial Sale Import Authorization

The notice explicitly says authorization will not extend to import of FDA‑approved or non‑approved finished dosage forms for commercial sale. If you planned to import these drugs for commercial sale, this registration would not permit that activity.

Comment and Hearing Deadline: Dec 26, 2025

Registered bulk manufacturers of the affected drug classes, applicants, and other interested parties may submit electronic comments or objections, or file a written request for a hearing, on or before December 26, 2025. Comments must be submitted through Regulations.gov; hearing requests must be filed with DEA addresses listed in the notice.

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Key Dates

Published Date
Comments Due
11/26/2025
12/26/2025

Department and Agencies

Department
Independent Agency
Agency
Justice Department
Drug Enforcement Administration
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