OMUFA - Screening Non-Sterile OTC Monograph Products for Microbial Contamination

The Food and Drug Administration is preparing to initiate a study focused on screening non-sterile, aqueous-based over-the-counter monograph drugs for microbial contamination. This initiative aims to strengthen the FDA’s ability to monitor the safety and quality of OTC monograph products by identifying potential microbial hazards that could lead to adverse health outcomes. The research will contribute to a more robust surveillance system, helping to reduce the occurrence of product-related illnesses and improve public health protections. The contract, titled “OMUFA - Screening Non-Sterile OTC Monograph Products for Microbial Contamination,” is listed under NAICS code 541714 and is currently in forecast status with a posted date of May 25, 2026. The effort will be led by the FDA’s Center for Drug Evaluation and Research, with the program point of contact available through cderacquisitions@fda.hhs.gov. The contracting officer role has not yet been assigned, and there is no specified place of performance or set-aside designation. This opportunity is intended to support regulatory oversight and may inform future guidelines or enforcement actions related to microbial safety in non-sterile OTC drugs.