PPB October 2020

D id you wash your hands? The Centers for Disease Control (CDC) and Prevention’s published guidance for hand sanitation is to wash with soap and warmwater for a minimum of 20 seconds. But the lack of access to water, when needed, and today’s mobile lifestyles can thwart our efforts to maintain good hand hygiene, leaving us exposed to germs and other infectious agents. The convenience and portability of hand sanitizer is a suitable alternative that works well just about anywhere. This article provides a brief history detailing the applicable regulations and labeling requirements, potential challenges for companies pivoting to production of hand sanitizer during the current pandemic and common reasons for hand sanitizer recalls, along with best practices. History Ethyl alcohol (also referred to as ethanol or, commonly, as alcohol) has been used as an antiseptic since the Middle Ages. Alcohol- based disinfectant hand rubs (the medical term for hand sanitizers) are also listed among the safest and most effective medicines used in modern health-care systems. In the United States, S. C. Johnson & Son, Inc. owned the patent for a skin moisturizing/ conditioning antimicrobial alcoholic gel until 2009, when the patent expired. Since the start of the pandemic earlier this year, the Food and Drug Administration (FDA) has recommended a 60-75-percent ethanol-based solution that largely follows the formula of the original patent. Alcohol-free hand sanitizers are also commercially available. These products may contain povidone-iodine, benzalkonium chloride or triclosan as active ingredients. Alcohol-free sanitizers are, however, susceptible to contamination and have been subject to recalls for bacterial contamination. For this reason, the CDC continues to advocate alcohol-based formulas. Regulatory Background Hand sanitizer is regulated as an over-the-counter (OTC) drug by the U.S. Food and Drug Administration (FDA). The FDA regulates not only the contents of such products but also the Hand Sanitizer: What To Know Before You Buy The increased demand for hand sanitizer has brought new manufacturers, repackagers and others to the market. Here’s a quick guide to better understand formulas, labels, shipping and more. by D.E. Fenton Here / Boyloso / Anna Tryhub / Shutterstock.com Photo illustration by SPARK Publications 80 | OCTOBER 2020 | THINK