CalCog Applies to Import Controlled Substances for Clinical Trials
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
CalCog Inc. is seeking DEA approval to import specific Schedule I controlled substances, including LSD, 5-MeO-DMT, DMT, and psilocyn, as dosage units for clinical trials only. The notice gives registered bulk manufacturers and related applicants until July 8, 2026, to submit comments, objections, or hearing requests. The registration would not authorize other activities involving these drug codes.
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Key Changes
- CalCog Inc. has applied for DEA registration as an importer of four Schedule I controlled substances.
- The substances would be imported only as dosage units for clinical trials.
- Registered bulk manufacturers and related applicants have until July 8, 2026, to comment, object, or request a hearing.
Obligations
What this law requires
Registered bulk manufacturers of the affected controlled substance classes, and applicants for those classes, may submit electronic comments or objections to DEA regarding CalCog Inc.'s proposed importer registration through Regulations.gov.
Any registered bulk manufacturer or applicant requesting a hearing on CalCog Inc.'s importer application must send the written hearing request to the DEA Hearing Clerk/OALJ, the DEA Federal Register Representative/DPW, and the DEA Administrator at 8701 Morrissette Drive, Springfield, Virginia 22152.
DEA's proposed importer registration for CalCog Inc., if granted, would authorize importation only of the listed Schedule I controlled substances as dosage units for clinical trials, and would not authorize other activities involving those drug codes.