Federal Register #2026-21370

DEA Controlled-Substance Import and Bulk-Manufacturing Registration Notices

The Department of Justice’s Drug Enforcement Administration published controlled-substance registration notices involving import applications by Halo Pharmaceutical Inc. and Organic Standards Solutions International, LLC, and a bulk-manufacturer application by Groff Health Inc. - Government agency: Department of Justice, Drug Enforcement Administration (DEA). - Applicants and proposed activities: - Halo Pharmaceutical Inc. seeks to import psilocybin (drug code 7437) for formulation development and clinical trials. - Organic Standards Solutions International, LLC seeks to import ten controlled substances to produce analytical reference standards for sale and distribution to customers. - Groff Health Inc. seeks to bulk manufacture ibogaine, 3,4-methylenedioxymethamphetamine (MDMA), psilocybin, and psilocyn for internal use and sale to customers. - Organic Standards Solutions International’s listed substances are Marihuana Extract (7350), Marihuana (7360), Tetrahydrocannabinols (7370), 3,4-Methylenedioxymethamphetamine (7405), Psilocybin (7437), Psilocyn (7438), 1-[1-(2-Thienyl)Cyclohexyl]Piperidine (7470), Acetyl Fentanyl (9821), Cocaine (9041), and Fentanyl (9801). - Notable restrictions: Organic Standards Solutions International states that Marihuana Extract and Marihuana will be used only to manufacture cannabidiol, and that it plans to import synthetic Tetrahydrocannabinols. The registration applications do not constitute a government purchase, and no quantities or contract period are specified.

Description

Organic Standards Solutions International, LLC applied to the Drug Enforcement Administration to be registered as an importer of specified basic classes of controlled substances. The company plans to import the listed substances to produce analytical reference standards for sale and distribution to its customers. Marihuana Extract and Marihuana will be used for the manufacture of cannabidiol only, and the company plans to import a synthetic version of Tetrahydrocannabinols. Comments or objections, and requests for a hearing, may be submitted on or before November 18, 2026.

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