Opportunity
Federal Register #2026-17285
DEA Notice: Importation of Morphine Sulfate USP Raw Material for Bulk Manufacturing
Buyer
Drug Enforcement Administration
Posted
August 25, 2026
Respond By
September 24, 2026
Identifier
2026-17285
NAICS
424210
This opportunity concerns the application by Prof. Compounding CTS of Ameri to import Morphine Sulfate USP for bulk manufacturing under the DEA's oversight. - 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) - Requested as a narcotic raw material - Intended for domestic bulk manufacturing and supply - Supports the ASPR Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) Program - No finished dosage forms (FDA-approved or nonapproved) may be imported for commercial sale - Unique or Notable Requirements: - Importation is strictly for raw material to be converted into finished pharmaceutical products by qualified U.S. manufacturers - Focus is on national preparedness and resilience for essential controlled substance APIs - No other activities for this drug code are authorized under this application
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.