Federal Register #DEA-1749

DEA Notice: Vici Health Sciences Application to Import Schedule I Fentanyl-Related Substance for Research and Clinical Trials

This opportunity concerns the Drug Enforcement Administration (DEA) notice for Vici Health Sciences, LLC's application to import a Schedule I controlled substance for research and clinical trial manufacturing. - Government Buyer: - Drug Enforcement Administration (DEA), U.S. Department of Justice - OEMs and Vendors: - Vici Health Sciences, LLC (applicant/importer) - Products/Services Requested: - Fentanyl-related substance - Drug code: 9850 - Schedule I controlled substance - Purpose: Importation for manufacturing processes supporting research and clinical trials - Quantity: Not specified - Unique or Notable Requirements: - Importation is strictly limited to research and clinical trial manufacturing purposes - No authorization for importation of finished dosage forms for commercial sale (FDA-approved or non-approved) - Registration does not permit other activities for this drug code - DEA is soliciting public comments and objections; hearing requests are permitted - Docket No.: DEA-1749

Description

Vici Health Sciences, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s), specifically fentanyl-related substances. The company plans to import these substances as part of a manufacturing process supporting research and clinical trial efforts. No other activity for this drug code is authorized for this registration. Comments or objections to the issuance of the proposed registration must be submitted by September 24, 2026, and requests for a hearing must also be filed by this date.

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