Federal Register #DEA1757

DEA Solicitation for Importation of Morphine Sulfate USP for Bulk Manufacturing

This opportunity concerns the importation of controlled substances for strategic pharmaceutical manufacturing in the United States. - Government Buyer: - U.S. Department of Justice, Drug Enforcement Administration (DEA) - OEMs and Vendors: - Prof. Compounding CTS of Ameri (applicant and importer) - Products/Services Requested: - Morphine Sulfate USP (drug code 9300, Schedule II) - Purpose: Used as a narcotic raw material for domestic bulk manufacturing and supply - Program: ASPR Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) - End Use: Conversion into finished pharmaceutical products by qualified U.S. manufacturers - Quantity: Not specified - Unique or Notable Requirements: - Importation is strictly for use as a raw material under the SAPIR Program - No authorization for importation of finished dosage forms (FDA-approved or nonapproved) for commercial sale - No other activities for this drug code are permitted under this registration - The only OEM/vendor mentioned is Prof. Compounding CTS of Ameri.

Description

Prof. Compounding CTS of Ameri has applied to be registered as an importer of basic class(es) of controlled substance(s). The company plans to import Morphine Sulfate USP as a narcotic raw material for domestic bulk manufacturing and supply under the ASPR Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) Program. The imported material will support the strategic domestic supply of essential controlled substance Active Pharmaceutical Ingredients for national preparedness and resilience, including conversion into finished pharmaceutical products by qualified U.S. manufacturers as needed. No other activity for this drug code is authorized for this registration. Approval of permit applications will occur only when the registrants business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA-approved or nonapproved finished dosage forms for commercial sale.

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