Two-tier risk model for antiseptics suggested in lieu of user classification.
This article was originally published in The Rose Sheet
Executive Summary
ANTISEPTIC PRODUCT TWO-TIER RISK-BASED METHOD SUGGESTED by Elaine Larson, PhD, Georgetown University School of Nursing, to FDA's Nonprescription Drugs Advisory Committee at a meeting in Bethesda, Md. July 29 during which the committee considered effectiveness testing for final antiseptic hand wash formulations. Speaking as a committee guest, Larson said FDA's tentative final monograph for heath care antiseptic products categorization by product user, such as health care, food handler or consumer, should be changed to risk of contamination.