503B-Compliant IV Narcotics Compounding and Manufacturing

The contract entails the manufacture and compounding of sterile intravenous narcotic medications in full compliance with FDA 503B regulations and current Good Manufacturing Practices, specifically for use at the NIH Clinical Center in Bethesda, Maryland. The work requires precise adherence to federal standards for sterile product production, including quality control, documentation, and facility sterility protocols to ensure patient safety and regulatory compliance. The subcontract is intended to support the clinical needs of the National Institutes of Health through the reliable supply of high-purity narcotic formulations used in patient care. Performance is mandated to occur at a facility meeting cGMP requirements, with all products destined for use within the NIH Clinical Center at the 20892 zip code. The opportunity was posted on May 1, 2026, and responses are due by May 6, 2026, at 1:00 PM Eastern Time. The North American Industry Classification System code 325412 identifies the sector as pharmaceutical and medicine manufacturing. The contract is issued under the Department of Health and Human Services through the National Institutes of Health Office of Laboratory Animal Welfare, with no set-aside provisions applied, indicating the award is open to all qualified vendors regardless of small business status.