Overview of US sanitiser regulations and formulas

The use of hand sanitisers has steadily increased over the past ten years. Their use began in hospitals, doctor’s offices, clinics and healthcare facilities. Then, we started seeing dispensers in building entrances, by elevators and in many common areas. Due to the recent COVID pandemic, there was an exponential increase in the use of hand sanitisers. Dispensers were placed in most stores’ entrances and in multiple locations in every store. Hand sanitisers were no longer sold in pharmacies only, but they are sold everywhere, including hardware stores. One can purchase a gallon of sanitising hand lotion at a time instead of the usual 12 to 16 oz containers

In the United States, hand sanitisers are also called “consumer antiseptic rubs” and are regulated by the Food and Drug Administration (FDA). They are considered Over the Counter Drugs (OTC) and fall under the Consumer Antiseptic Rub Products Monograph. This monograph is not finalised yet, but tentative final monographs have been published in the Federal Register in 2016, 2017 and 2019.1,2,3 The most recent tentative final monograph does not classify any active as Category I (Safe and effective). However, it classifies three actives as Category III (More data needed for safety and efficacy). These actives are:

The monograph requires marketers of such products to test the products for safety and efficacy. Efficacy should be tested both in vitro and in vivo. In vitro testing requires the determination of antimicrobial activity of the antibacterial active by conducting a battery of antimicrobial tests using certain bacterial strains. Three tests are suggested in the monograph, namely Minimum Inhibitory Concentration (MIC), Minimum Bactericidal Concentration (MBC) and time-kill testing of certain strains. Regarding in vivo testing, the monograph specifies conducting two clinical studies with a minimum enrolment of 100-person each in two separate centres to evaluate efficacy. Efficacy is typically evaluated using bacterial log reduction after product application as compared to a placebo.