Federal Register #DEA-1697

DEA Notice: Indivior Manufacturing LLC Application to Import Thebaine for Research and Development

This opportunity concerns the Drug Enforcement Administration's (DEA) notice regarding Indivior Manufacturing LLC's application to import the controlled substance Thebaine for specific non-commercial purposes. - Government Buyer: - Department of Justice, Drug Enforcement Administration (DEA) - OEMs and Vendors: - Indivior Manufacturing LLC (applicant and importer) - Thebaine (Schedule II controlled substance) is the only OEM product referenced - Products/Services Requested: - Importation of Thebaine (Drug Code 9333, Schedule II) - Intended uses: research, clinical trials, analytical purposes, and manufacturing process development of dosage forms - No finished dosage forms for commercial sale are authorized - Unique or Notable Requirements: - Importation is strictly limited to non-commercial activities (no commercial sale) - DEA is soliciting comments or objections from registered bulk manufacturers and applicants - Registration is for limited quantities and specific scientific/manufacturing purposes only

Description

Indivior Manufacturing LLC has applied to be registered as an importer of the basic class of controlled substance Thebaine, Schedule II. The company plans to import this controlled substance in limited quantities for research, clinical trials, analytical purposes, and manufacturing process development of dosage forms. Comments or objections to the issuance of the proposed registration are due by May 1, 2026, and requests for a hearing must also be submitted by this date. The registration does not authorize import of finished dosage forms for commercial sale.

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