Overview of US sanitiser regulations and formulas

Dr Hani Fares – NYSCC, US

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


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: ■ Alcohol (Denatured) at 60-90%. ■ Isopropyl Alcohol at 70-91.3%. ■ Benzalkonium Chloride. 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. Due to the recent COVID pandemic,

the FDA issued a temporary guidance for alcohol-based hand sanitiser production.4 The guidance allowed FDA-registered manufacturers to produce alcohol-based hand sanitisers based on the following formulation: ■ Alcohol (denatured ethanol formulated to 80% v/v) in aqueous solution or Isopropyl Alcohol (formulated to 75% v/v) in aqueous solution. ■ Glycerin 1.45% v/v ■ Hydrogen Peroxide (0.125% v/v) ■ Sterile distilled water or boiled cold water. The stipulation was that other additives

cannot be added to this formulation, including fragrance. The formulation is not supposed to be thickened and should be in the form of a solution only. The formulation cannot be used as a foam or an aerosol either.

Formulating sanitisers Now for the fun stuff, formulating a hand sanitiser product. The leading method of dispensing hand sanitisers in most facilities are the motion-sensing foam dispensers. These dispensers typically are filled with an alcohol-based solution that foams when



Dr. Fares started his career in personal care studying the effect of solvents on sunscreen chemicals. His interest in skin drug delivery especially from polymeric matrices grew during his graduate work at Rutgers, where he received his PhD. Dr Fares worked at Block Drug and

GlaxoSmithKline where he held positions in research and development in the areas of skincare and oral care. After that, he joined L’Oreal where he held several positions of increasing responsibility leading to AVP of skin care. He is currently the Senior Director of skin care and oral care at Ashland Specialty Ingredients. Dr. Fares is the author of many publications, and patents and made many presentations in national and international meetings in the areas of suncare, skincare, and oral care. Dr Fares chairs the NYSCC scientific committee and has won multiple awards in the area of sun care and polymer chemistry.

dispensed. The formulation contains 70% alcohol for sanitising and PEG-12 dimethicone as a foaming agent. It also contains glycerin (a well-known moisturiser), tocopherol acetate and a couple of esters to replenish skin lipids as well as a mild fragrance to cover the alcohol smell.

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