Federal Register #2026-22289

DEA controlled-substance manufacturing and import applications

This Department of Justice notice covers controlled-substance manufacturing and import applications, alongside a Bureau of Prisons fee determination. - Government entities: Department of Justice (DOJ), including the Drug Enforcement Administration (DEA) and the Bureau of Prisons (BOP). - Applicants named: AJNA Biosciences applied to bulk manufacture Schedule I substances; Globyz Pharma LLC applied to import a Schedule II substance. - Products and codes: - Marihuana Extract — drug code 7350; Schedule I. - Marihuana — drug code 7360; Schedule I. - Tetrahydrocannabinols — drug code 7370; Schedule I. - Fentanyl — drug code 9801; Schedule II; import in dosage form for analytical testing and development. - AJNA Biosciences’ stated uses: An FDA-regulated drug program involving whole-plant marihuana cultivation for internal research, clinical trials, analytical purposes, and distribution to customers. - Other notice: The attachment also announces a BOP Cost of Incarceration Fee determination. No fee amount is specified in the provided summary. - These are regulatory notices, not requests to purchase products or services. The DEA notice invites comments, objections, and hearing requests concerning the proposed registration.

Description

AJNA Biosciences applied to be registered as a bulk manufacturer of basic classes of controlled substances. The listed substances are marihuana extract, marihuana, and tetrahydrocannabinols (drug codes 7350, 7360, and 7370), all Schedule I. The company plans to bulk manufacture the substances and initiate a new FDA-regulated drug program cultivating whole-plant marihuana for internal research, clinical trials, analytical purposes, and distribution to customers. Comments or objections, and hearing requests, are due by January 4, 2027.

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