Federal Register #DEA-1734

DEA Review of Almac Clinical Services Application to Import Controlled Substances for Clinical Trials

This opportunity involves the Drug Enforcement Administration (DEA), part of the Department of Justice, reviewing an application from Almac Clinical Services Incorp. (ACSI) for importer registration of controlled substances. - Government Buyer: - Department of Justice (DOJ) - Drug Enforcement Administration (DEA) - Applicant/Vendor: - Almac Clinical Services Incorp. (ACSI) - Products/Controlled Substances Requested: - Psilocybin (drug code 7437, Schedule I) - Oxycodone (9143, Schedule II) - Hydromorphone (9150, Schedule II) - Morphine (9300, Schedule II) - Tapentadol (9780, Schedule II) - Fentanyl (9801, Schedule II) - Purpose: - Importation of finished dosage form units for clinical trial use only - Unique/Notable Requirements: - Registration does not authorize importation for commercial sale of FDA-approved or non-approved finished dosage forms - No specific quantities or part numbers provided - DEA is soliciting comments and objections from interested parties

Description

Almac Clinical Services Incorp. (ACSI) has applied to be registered as an importer of basic classes of controlled substances including Psilocybin, Oxycodone, Hydromorphone, Morphine, Tapentadol, and Fentanyl. The company plans to import these substances as finished dosage form units for clinical trial purposes only. Comments and objections to the application are due by July 30, 2026, and interested parties may request a hearing by the same date. The registration will not authorize import for commercial sale of FDA-approved or non-approved finished dosage forms.

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