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U.S. Department of Health and Human Services

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Summary: Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph (Proposed Rule)

The Food and Drug Administration (FDA) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products.  In this proposed rule, FDA is proposing to establish conditions under which OTC consumer antiseptic products intended for use with water (referred to throughout as consumer antiseptic washes) are generally recognized as safe and effective. In the 1994 TFM, certain antiseptic active ingredients were proposed as being safe for antiseptic handwash use by consumers based on safety data evaluated by FDA as part of an ongoing review of OTC antiseptic drug products.  However, in light of more recent scientific developments and changes in the use patterns of these products FDA is now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for this use.  FDA is also proposing that all consumer antiseptic wash active ingredients have data that demonstrate a clinical benefit from the use of these consumer antiseptic wash products compared to nonantibacterial soap and water.

Regulatory Impact Analysis

Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph Preliminary Regulatory Impact Analysis (PDF - 261KB)

Federal Register: 78 FR 76443-76478, December 17, 2013

Docket: FDA-1975-N-0012 (Formerly 1975N-0183H)