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What does "Patient Preoperative Skin Preparation" mean?

In its Tentative Final Monograph (TFM) entitled “Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products”, the FDA defines a patient preoperative skin preparation as “a fast-acting [rapidly kills microorganisms] broad-spectrum [kills a wide variety of micro-organism species] persistent [suppresses regrowth of remaining micro-organisms] antiseptic-containing preparation that significantly reduces the number of micro-organisms on intact skin.”  The FDA currently considers this to be a single vs. multiple use indication – see FAQ "With respect to antiseptics, what is meant by multiuse vs. single use products?"

For a copy of the TFM (2.9 Mb), click here.

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