Federal Register #DEA1692

DEA Solicitation: Import Registration for Controlled Substances by Pharmaron Manufacturing Services (US) LLC and Usona Institute

This opportunity concerns applications to the Drug Enforcement Administration (DEA) for registration as importers of controlled substances for research and manufacturing purposes. - Government Buyer: - Department of Justice, Drug Enforcement Administration (DEA) - OEMs and Vendors: - Pharmaron Manufacturing Services (US) LLC - Usona Institute - Products/Services Requested: - Pharmaron Manufacturing Services (US) LLC: - Poppy Straw Concentrate (Schedule II, part number 9670) - Intended for manufacturing commercial bulk Active Pharmaceutical Ingredients (APIs) and analytical development - Import of finished dosage forms for commercial sale is not authorized - Usona Institute: - Mescaline (Schedule I, part number 7381) - 5-Methoxy-N-N-dimethyltryptamine (Schedule I, part number 1245) - Dimethyltryptamine (Schedule I, part number 1595) - Psilocybin (Schedule I, part number 7043) - Psilocyn (Schedule I, part number 7090) - All for research and analytical purposes only (not for clinical trials or human consumption) - Unique or Notable Requirements: - Importation is strictly for bulk manufacturing or research/analytical use - No finished dosage forms may be imported for commercial sale - DEA is soliciting public comments and objections; hearings may be requested - Locations: - DEA Headquarters, Springfield, VA (contracting/government office) - Pharmaron Manufacturing Services (US) LLC, Coventry, RI (place of performance) - Usona Institute, Fitchburg, WI (place of performance) - Bureau of Justice Statistics, Washington, DC (government facility) - Additional Service Mentioned: - 2025 Census of Prosecutor Offices (data collection survey; not directly related to the controlled substances import applications)

Description

Pharmaron Manufacturing Services (US) LLC has applied to be registered as an importer of controlled substances, specifically Poppy Straw Concentrate (Schedule II). The company plans to import bulk substances to manufacture commercial bulk Active Pharmaceutical Ingredients and for analytical technology transfer and development. Comments and objections to the application are due by April 29, 2026, and a hearing may be requested. The registration does not authorize import of finished dosage forms for commercial sale.

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