FDA-Compliant OTC Pharmaceutical Manufacturing

The contract pertains to the manufacture of BenzoCaine Gel, USP, in strict adherence to FDA Over-the-Counter (OTC) drug monograph standards and applicable military specifications, ensuring the product meets regulatory and operational requirements for use by military personnel. The work must be performed in accordance with current Good Manufacturing Practices and quality control protocols necessary for pharmaceutical products destined for federal use, with the place of performance designated as FPO, ZIP 96694-1500. The solicitation, classified as a subcontract under NAICS code 325412 for pharmaceutical preparation manufacturing, was posted on May 10, 2026, with a firm response deadline of May 18, 2026, emphasizing timely submission for consideration. The contracting activity falls under the Department of Defense through the Medical Supply Chain Pharm FSA, indicating the product is intended for defense medical supply chains and requires full compliance with federal procurement and pharmaceutical standards.