Alcohol-Based Hand Sanitizers in COVID-19 Prevention
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Contributing OfficeCenter for Drug Evaluation and Research
Abstract
The Food and Drug Administration has a crucial role in protecting the United States public from arising infectious diseases, like the Coronavirus Disease 2019 (COVID-19) pandemic. Hand hygiene is one of the key aspects of the U.S. response to COVID-19, which has resulted in an increase of the use of alcohol-based hand sanitizers. The CDC recommends washing hands frequently with soap and water for at least 20 seconds, particularly after using the bathroom; before eating; and after coughing, sneezing, or blowing one's nose. If soap and water are not easily available, the CDC recommends using an alcohol-based hand sanitizer with at least 60 percent ethanol. Hand Sanitizers are manufactured as gel, foam, liquid, spray, or wipe. As an over the counter drug product, the FDA regulates the different types of hand sanitizer products that are available in the market. The FDA has published temporary guidance documents on the manufacturing and testing of hand sanitizer products for assay content and impurity limits to ensure the safety and efficacy of hand sanitizers in public health. The FDA is warning consumers and health care workers that there has been a significant increase in the number of hand sanitizer products testing positive for methanol or 1-propanol as potential toxic contamination despite being advertised as containing ethanol. The CDER’s OPQ Office of Quality Surveillance (OQS) has issued a sampling assignment to verify that alcohol-based hand sanitizers have the required concentration of alcohol content and do not have toxic impurities such as methanol, benzene, acetal, and acetaldehyde. Using the sensitive and specific methods developed by OTR, hand sanitizer products have been tested for alcohol content and potential toxic impurities that may be present in concentrations above the limits the FDA Temporary Guidance to Industry allows.