While everyone in our industry struggles with the ramifications of the COVID-19 pandemic, distilled spirits plant (“DSP”) production of hand sanitizer or ethanol (whether denatured or not) for use in hand sanitizer is a particularly important topic. The Food and Drug Administration (“FDA”) and Alcohol and Tobacco Tax and Trade Bureau (“TTB”) are issuing guidance on a seemingly daily basis.
To that end, TTB released Public Guidance 2020-1A on Thursday March 26, 2020, updating its previous March 18th guidance regarding the production of hand sanitizer. This new guidance contains several important points for DSPs moving forward and is valid until June 30, 2020 unless extended by TTB.
First, a DSP may manufacture hand sanitizer without obtaining TTB formula approval if the DSP uses a formula cited by FDA in its March 23, 2020 guidance titled Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). Although TTB tries to approve non-beverage alcohol product formulas within 10 days or so, by utilizing one of the formulas identified by FDA, DSPs can start producing hand sanitizer as soon as practical. If this saves you even a few days it can go a long way toward helping health professionals and many others who need hand sanitizer.
Second, a DSP does not need to...Continue Reading Leave a Comment