Federal Register #DEA-1757

DEA Notice: Importation of Morphine Sulfate USP for Bulk Manufacturing by Prof. Compounding CTS of Ameri

This DEA notice concerns Prof. Compounding CTS of Ameri's application to import Morphine Sulfate USP for national pharmaceutical manufacturing. - Government Buyer: - Drug Enforcement Administration (DEA), U.S. Department of Justice - OEM/Vendor: - Prof. Compounding CTS of Ameri - Product Requested: - Morphine Sulfate USP (drug code 9300, Schedule II) - Quantity not specified - Intended as a narcotic raw material for bulk manufacturing - Purpose and Use: - For domestic bulk manufacturing and supply under the ASPR Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) Program - Supports national preparedness and resilience - Material will be converted into finished pharmaceutical products by qualified U.S. manufacturers - Unique Requirements: - No other activities for this drug code are authorized - Importation of finished dosage forms (FDA-approved or nonapproved) for commercial sale is not permitted - Notice invites comments and hearing requests from registered bulk manufacturers and applicants

Description

Prof. Compounding CTS of Ameri has applied to be registered as an importer of basic class(es) of controlled substances. 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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