FDA Data Request for Hand Sanitizers

On June 29th, 2016 in alignment with their ongoing review of over-the-counter antiseptic active ingredients, the FDA notified the public of a proposed rule requiring additional information from manufacturers of hand sanitizers and wipes. The proposed rule is open for comment until December 26, 2016.

  

 

FDA is particularly interested in the topical absorption of each active ingredient, safety over daily long-term use of the products, and effects on pregnant women and children.

Products may remain on the market while FDA reviews data provided by manufacturers.

Microchem Laboratory routinely conducts efficacy testing for hand hygiene products. If your company would like to discuss testing, please contact the lab.