USP Expands Alcohol-based Hand Sanitizer Support in Response to Quality Incidents

In response to the alcohol-based hand sanitizer quality incidents reported across the globe, the U.S. Pharmacopeia (USP) is offering free access to USP-NF standards, information and on-demand education related to producing quality alcohol-based hand sanitizer. Additionally, USP is hosting a global seminar series, Ensuring Quality Hand Sanitizer Production During COVID-19, bringing together leading experts from regulatory agencies, public health institutions and industry to discuss challenges associated with quality alcohol-based hand sanitizer and provide additional resources to produce (including ingredients such as alcohol), label, package, and distribute quality alcohol-based hand sanitizers.

COVID-19-related supply chain pressures have created global shortages that led to new vendors, materials and production pathways to meet demand. These fast-paced changes have caused an emergence of quality incidents both regionally and globally. Globally, over 200 alcohol-based hand sanitizer quality incidents have been reported in 2020. For example, in the United States, one batch of contaminated alcohol-based hand sanitizer caused 15 cases of hospitalized methanol poisoning, which led to four patient deaths and three with visual impairments.

"Alcohol-based hand sanitizer is an important element in infection prevention, especially during the COVID-19 pandemic. However, when quality is compromised, it can be less effective against infection transmission and can also lead to user harm," said Jaap Venema, chief science officer for USP. "Together, we must remain vigilant to help ensure the quality of alcohol-based hand sanitizers and support its safe use."