In the May 1, 2015, Federal Register, FDA
issued a proposed rule to amend the 1994 tentative final monograph
for over-the-counter ("OTC") antiseptic drug products.
The proposed rule would establish conditions under which OTC
antiseptic products intended for use by health care professionals
are generally recognized as safe and effective, and it would
institute additional measures, such as in vitro data
characterizing the antimicrobial properties of active ingredients
and in vivo clinical simulation studies showing that
specified log reductions in the amount of certain bacteria are
achieved using the ingredient. The notice includes proposed
classifications for active ingredients used in OTC antiseptics.
Comments are due October 28, 2015.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
