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What are the FDA and TFM?

The Food and Drug Administration (FDA) is the regulating body within the federal government for medical devices and drugs; antiseptic products are generally considered drugs.  While the FDA publishes numerous Tentative Final Monographs (TFM’s) describing how various product groups are to be regulated (i.e., qualified and labeled for various indications for use), the TFM referenced with respect to antiseptic products was most recently published in 1994 and is entitled “Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products”.  Not all antiseptic products are qualified for all the uses contemplated in the TFM; i.e., healthcare personnel handwash, surgical hand scrub, patient preoperative skin preparation, and patient preinjection skin preparation.

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

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