Current Edition

FDA Addressing Data Gaps for Consumer Antiseptic Rubs

In this column, Deborah A. Komlos, MS, Senior Medical &
Regulatory Writer for the Cortellis Regulatory Intelligence
US Module at Thomson Reuters, discusses an issue regarding
over-the-counter (OTC) consumer antiseptic rub products. The
US Food and Drug Administration (FDA) recently issued a
proposed rule requesting additional scientific data to establish
the safety and effectiveness of particular active ingredients
used in these products (e.g., hand “sanitisers” and wipes). They
are intended for use when soap and water are not available,
and are left on and not rinsed off with water.….pdf