Federal Register #DEA-1761

DEA Notice: Import Registration Application for Remifentanil by Fresenius Kabi USA, LLC

The Drug Enforcement Administration (DEA) has announced a notice regarding an import registration application from Fresenius Kabi USA, LLC. - Government Buyer: - Department of Justice, Drug Enforcement Administration (DEA) - OEM/Vendor: - Fresenius Kabi USA, LLC - Product Requested: - Remifentanil (Drug Code 9739, Schedule II) - Requested as a bulk active pharmaceutical ingredient - Intended use: manufacturing FDA-approved dosage forms - No authorization for import of finished dosage forms for commercial sale - Unique Requirements: - Registration is strictly for import of bulk Remifentanil for manufacturing purposes - DEA is soliciting comments or objections from registered bulk manufacturers and applicants - Interested parties may request a hearing - Only Fresenius Kabi USA, LLC is mentioned as the applicant and OEM - Remifentanil is the sole product specified

Description

Fresenius Kabi USA, LLC has applied to be registered as an importer of basic class(es) of controlled substances. The application is for registration to import controlled substances as bulk active pharmaceutical ingredients to manufacture FDA-approved dosage forms. Comments or objections can be submitted electronically or in writing on or before October 8, 2026. Interested parties may request a hearing by October 8, 2026. The application is associated with Docket No. DEA-1761 under the Justice Department, Drug Enforcement Administration.

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