The 'Rub' On Leave-On Consumer Antiseptics: FDA Seeks Safety, Efficacy Data
This article was originally published in The Rose Sheet
Executive Summary
Firms that want to continue marketing consumer antiseptic rubs, or leave-on hand sanitizers and wipes used without water, are asked to submit GRAS/GRAE data to the agency under a June 30 proposed rule. Comments are being accepted for 180 days and new data or information for one year.
You may also be interested in...
Freedom Caucus Hit List Includes Antibacterial Soap, Supplement Label Rules
The caucus of 36 conservative Republicans lists 200 rules passed during the Obama administration, or the that president established through executive orders, that it recommends striking altogether or changing to lessen industries' regulatory burden.
FDA Rule Marks Consumer Antibac Soaps A Possible Endangered Species
FDA’s rule “clarifies the mission” for manufacturers of consumer antibacterial soaps, which have a year to demonstrate that they are safe and effective or risk losing the entire OTC drug category.
FDA Rule Marks Consumer Antibacterial Soaps An Endangered Category
FDA’s final rule “clarifies the mission” for manufacturers of consumer antibacterial soaps, which have a year to demonstrate that benzalkonium chloride, benzethonium chloride and chloroxylenol are safe and effective or risk losing the entire OTC drug category. The rule bars firms from marketing consumer antiseptic wash products containing triclosan, triclocarban and 17 other lesser-used active ingredients.