Federal Register #2026-13705

DEA Considers Benuvia Operations, LLC Application to Import Controlled Substance APIs

This opportunity involves the Drug Enforcement Administration (DEA) considering an application for importer registration of controlled substance active pharmaceutical ingredients (APIs): - Government Buyer: - Drug Enforcement Administration (DEA), U.S. Department of Justice - Applicant/Vendor: - Benuvia Operations, LLC - Products/Controlled Substances Requested for Import (APIs only): - Marihuana Extract (Drug Code 7350, Schedule I) - Psilocybin (7437, I) - Psilocyn (7438, I) - Amphetamine (1100, II) - Lisdexamfetamine (1205, II) - Ecgonine (9180, II) - Remifentanil (9739, II) - Notable Requirements: - Registration is strictly for importing active pharmaceutical ingredients (APIs) only - No import of finished dosage forms (FDA-approved or nonapproved) for commercial sale is permitted - DEA is soliciting comments and objections from registered bulk manufacturers and applicants - No other activities for these drug codes are authorized under this registration - Only Benuvia Operations, LLC is named as the applicant; DEA is the sole government agency involved

Description

Benuvia Operations, LLC. has applied to be registered as an importer of basic classes of controlled substances. The application involves the import of active pharmaceutical ingredients to support their customers. The registration does not authorize any other activities for these drug codes and excludes the import of FDA-approved or nonapproved finished dosage forms for commercial sale. Comments and objections to the issuance of the proposed registration are due by August 6, 2026.

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