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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

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

The Food and Drug Administration (FDA) is issuing a proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In the proposed rule, FDA is proposing to establish conditions under which OTC consumer antiseptic products intended for use without water (referred to as consumer antiseptic rubs or consumer rubs) are generally recognized as safe and generally recognized as effective (GRAS/GRAE). In the 1994 TFM, certain antiseptic active ingredients were proposed as being GRAS for antiseptic rub use by consumers based on safety data evaluated by FDA as part of its 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 rub active ingredients have in vitro data characterizing the ingredient’s antimicrobial properties and in vivo clinical simulation studies showing that specified log reductions in the amount of certain bacteria are achieved using the ingredient.

Regulatory Impact Analysis

Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Consumer Antiseptic Rubs; Proposed Amendment of the Tentative Final Monograph Preliminary Regulatory Impact Analysis (PDF - 280KB)

Federal Register: 81 FR 42911, June 30, 2016

Docket: FDA-2016-N-0124 (Formerly Part of Docket No. FDA-1975-N-0012)