Screening of Non-Sterile OTC Monograph Drug Products for Microbial Contamination FDA-CDER-25-130338
Summary
AI-generated · Sep 10, 2025Contract laboratory will purchase approximately 70 non-sterile aqueous OTC monograph drug products and test them for microbial contamination using standard compendial methods during the contract period, to verify they meet pharmacopoeial contamination standards. The products are explicitly non-sterile (not labeled as sterile).
The overall scope of the project is to have a contract laboratory purchase and test ~70 aqueous OTC monograph drug product samples for microbial contamination using compendial test methods during the period of performance. These OTC drug products are not intended to be sterile (e.g., they are not labeled as sterile).
From Combined Synopsis/Solicitation posted on Sep 09, 2025Notice history
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USA