Federal Register #DEA-1696

DEA Registration Notice: Pharmaron Manufacturing Services to Manufacture Schedule II Controlled Substances for Clinical Trials

The Drug Enforcement Administration (DEA), part of the Department of Justice, is announcing a regulatory opportunity for Pharmaron Manufacturing Services (US) LLC to register as a bulk manufacturer of Schedule II controlled substances for clinical trial use. - Government Buyer: - Drug Enforcement Administration (DEA), Department of Justice - OEM/Vendor: - Pharmaron Manufacturing Services (US) LLC - Products/Services Requested: - Bulk manufacture of the following Schedule II controlled substances: - Oxycodone (Drug Code 9143) - Thebaine (Drug Code 9333) - Oxymorphone (Drug Code 9652) - Noroxymorphone (Drug Code 9668) - Purpose: Production of material for clinical trials only - Unique/Notable Requirements: - Registration is strictly for manufacturing the listed substances for clinical trials - No other activities for these drug codes are authorized under this registration - The DEA is accepting electronic comments or objections and hearing requests regarding this registration - Place of Performance: - Coventry, Kent County, Rhode Island (Pharmaron Manufacturing Services facility) - This is a regulatory registration notice, not a direct procurement of goods or services.

Description

Pharmaron Manufacturing Services (US) LLC has applied to be registered as a bulk manufacturer of basic classes of controlled substances, including oxycodone, thebaine, oxymorphone, and noroxymorphone, all Schedule II drugs. The company plans to manufacture these substances for clinical trials. Interested parties may submit comments or objections electronically or request a hearing by June 1, 2026.

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