Client Alert: FDA and TTB Guidance on Production of Hand Sanitizer to Address the COVID-19 Pandemic | Brouse McDowell | Ohio Law Firm
Menu
Insights

Client Alert: FDA and TTB Guidance on Production of Hand Sanitizer to Address the COVID-19 Pandemic

By Meagan L. Moore on March 26, 2020

In order to address the decreased market supply of hand sanitizer products resulting from the rapid spread of the COVID-19 pandemic, the Food and Drug Administration (FDA) issued two guidance documents to temporarily ease restrictions related to the manufacturing of certain alcohol based hand sanitizer products, both effective immediately. The first guidance allows for the manufacturing of hand sanitizer products by businesses that do not generally manufacture such a product. Specifically, the guidance states the FDA does not intend to take action against businesses that prepare alcohol based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency provided a specific ingredient list is followed, the product has the necessary labels, as well as some general manufacturing specifics. Any manufacturing business wanting to contribute to the manufacturing of a hand sanitizer product must also register the facility and the product with the FDA.

Similarly, the second guidance allows for compounding by pharmacists in state licensed pharmacies, federal facilities or registered outsourcing facilities to compound certain alcohol based hand sanitizer rubs for the duration of the public health emergency provided a specific ingredient list is followed and the product has the necessary labels. This guidance also states the FDA does not intend to take action against businesses that prepare this product.

The Alcohol and Tobacco Tax and Trade Bureau (TTB) also released guidance to assist in increasing the volume of hand sanitizer on the market. This guidance allows distilleries to produce hand sanitizers during the public health emergency created by the COVID-19 pandemic.

Share Article Via