Federal Register #DEA-1792

DEA notices applications to manufacture Schedule I substances and import fentanyl

The Department of Justice published Drug Enforcement Administration notices concerning controlled-substance manufacturing and import applications. - Government buyer: U.S. Department of Justice (DOJ), Drug Enforcement Administration (DEA); the attached notice also references the Bureau of Prisons (BOP). - Named companies: AJNA Biosciences applied to bulk manufacture three Schedule I substances for a new FDA-regulated drug program. Globyz Pharma LLC applied to import Schedule II fentanyl in dosage form for analytical testing and development. - Substances and drug codes: - Marihuana Extract — 7350, Schedule I. - Marihuana — 7360, Schedule I. - Tetrahydrocannabinols — 7370, Schedule I. - Fentanyl — 9801, Schedule II. - AJNA Biosciences’ proposed purposes include research, clinical trials, analytical work, and customer sales. Globyz Pharma LLC’s application is limited to fentanyl imports for analytical testing and development; it does not propose importing finished dosage forms for commercial sale. - No quantities, commercial purchase, or service line items are specified. These notices concern applications for controlled-substance activities, not a conventional product procurement.

Description

Globyz Pharma LLC applied to register as an importer of fentanyl, a Schedule II controlled substance (drug code 9801). The company plans to import the substance in dosage form for analytical testing and development; no other activity for this drug code is authorized under the proposed registration. Eligible parties may submit electronic comments or objections, or request a hearing, by December 2, 2026.

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