Federal Register #DEA-1754

DEA Notice: Kinetochem LLC Application for Bulk Manufacturing of Schedule I Controlled Substance

This notice concerns Kinetochem LLC's application to the Drug Enforcement Administration (DEA) for registration as a bulk manufacturer of a Schedule I controlled substance. - Government Buyer: - U.S. Department of Justice, Drug Enforcement Administration (DEA) - OEMs and Vendors: - Kinetochem LLC (applicant and prospective manufacturer) - Curia Missouri Inc. (referenced as a similar applicant) - Vici Health Sciences, LLC (referenced as a similar applicant) - Products/Services Requested: - Bulk manufacturing registration for 3,4-Methylenedioxy-N-methylcathinone (drug code 7540, Schedule I) - Intended use: Active Pharmaceutical Ingredient (API) for customers, research, and clinical trials - No other activities authorized for this drug code - Unique/Notable Requirements: - Registration is strictly for manufacturing the specified Schedule I substance - DEA is soliciting public comments and objections regarding the application - Other referenced applications involve different controlled substances and activities, but the focus is on Kinetochem LLC's request

Description

Kinetochem LLC has applied to be registered as a bulk manufacturer of basic classes of controlled substances. The company plans to bulk manufacture the listed controlled substances as Active Pharmaceutical Ingredients for its customers as well as for research and clinical trials. Comments and objections to the application are due by October 26, 2026. Electronic comments can be submitted through the Federal eRulemaking Portal.

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