Federal Register #DEA-1705

DEA Review of Applications to Import Controlled Substances for Research

The Drug Enforcement Administration (DEA) is reviewing applications to import controlled substances for research purposes: - Government Buyer: - Drug Enforcement Administration (DEA), Department of Justice - OEMs and Vendors: - VA Cooperative Studies Program (federal research entity) - Leading Pharma LLC (pharmaceutical company) - Products/Services Requested: - Importation of Schedule I controlled substances for research and clinical trials by the VA Cooperative Studies Program - Marihuana Extract (drug code 7350) - Tetrahydrocannabinols (drug code 7370) - Importation of Schedule II controlled substance by Leading Pharma LLC for research and development - Diphenoxylate (drug code 9170) - Unique or Notable Requirements: - Importation is strictly for research and clinical trial use; commercial sale is prohibited - No other activities for these drug codes are authorized under these registrations - DEA is soliciting comments or objections from registered bulk manufacturers and applicants - Locations: - DEA headquarters in Springfield, VA (contracting office) - VA Cooperative Studies Program facility in Albuquerque, NM (place of performance) - Leading Pharma LLC in Fairfield, NJ (place of performance)

Description

The VA Cooperative Studies Program has applied to be registered as an importer of basic classes of controlled substances, specifically Schedule I substances including Marihuana Extract and Tetrahydrocannabinols. The registration is intended for importing finished dosage unit products containing these substances for research and clinical trial studies only. Comments or objections to the proposed registration may be submitted electronically by registered bulk manufacturers and applicants by May 21, 2026. Requests for hearings on the application must also be filed by this date.

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