Screening Sterile OTC Monograph Products for Microbial Contamination

The Food and Drug Administration's Office of Acquisition and Grant Services is seeking a contract laboratory to purchase and test approximately 70 aqueous sterile over-the-counter monograph drug products for microbial contamination. The contractor must possess ISO 17025 accreditation and will be responsible for procuring products, establishing chain of custody processes, verifying analytical methods from USP chapters, and conducting comprehensive sterile testing services on products including eye drops, oral solutions, nasal washes, and mouthwashes. The laboratory must provide detailed monthly progress reports and a final comprehensive report documenting all findings for FDA review. Proposals will be evaluated based on scientific merits, analytical capabilities, pricing, and proposed completion timeframe. Questions regarding the solicitation are accepted until August 8, 2025, with proposal submissions due by 9:00 AM Eastern Time on August 18, 2025.

This solicitation does not utilize any set-aside designations and no incumbent contractors are identified in the documentation. The contract involves testing approximately 2,240 total units across the 70 different products, with 32 units per product type, though recent clarifications indicate that actual unit quantities may vary based on container volume and testing requirements for sterility, endotoxin, and suitability testing. The performance period spans 12 months from September 16, 2025, to September 15, 2026, under a firm fixed price contract structure. The contract will include costs for both product purchase and laboratory testing services, with the contractor required to flexibly determine appropriate batch quantities based on actual product characteristics. Performance will take place within the United States, with the contractor responsible for procuring diverse liquid formulations including both aqueous and non-aqueous compositions across categories such as cold and cough medicines, ophthalmics, and various washes and rinses.