Covid-19 Guidelines regarding distillery production of hand sanitizer: EFFECTIVE IMMEDIATELY.
Any existing DSP can immediately commence production of hand sanitizer or distilled spirits (ethanol) for use in hand sanitizer without having to obtain authorization first.
Initially approved through June 30, 2020 with the possibility of extension as necessary.
Hand Sanitizer products are not subject to Federal excise tax if made with denatured ethanol.
However, if made with undenatured ethanol, Federal excise tax applies.
FDA does not intend to take action against firms that prepare alcohol-based hand sanitizers for consumer use as health care personnel hand runs through the duration of the public health emergency. Provided the following guidelines are adhered to:
Must register in the FDA Drug Registration and Listing System
Maintain records that document key steps and controls to assure each batch matches the formula developed for the product
Use labels that are consistent with Ethyl Alcohol labels in Appendix A of the Guidance Doc
Implement a process to accept and report adverse events to the FDA.
The ACSA strongly recommends following the World Health Organization guidelines on the Local Production of Hand Sanitizer. Please read through this information carefully to help guide you in your production process.
Before you start Production Ask Yourself the Following Questions:
Do you have the USP grade % Alcohol Required?
Can you readily source raw ingredients?
What can you use for packaging? Can you source plastics?
Click Here to access the PDF power point presentation from the ACSA which details and answers questions and provides further guidelines.
Guidance for Industry - Temporary Policy for the Manufacturer of Alcohol Based Hand Sanitizer
This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency.
Because of the public health emergency posed by COVID-19, FDA does not intend to take action against alcohol production firms that manufacture alcohol (i.e., ethanol or ethyl alcohol) for use as the Active Pharmaceutical Ingredient (API) in alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, provided the following circumstances are present: Guidance For Industry
What We're Doing at OnBatch
We quickly developed a calculator to help out during these times of need.
Hand Sanitizer Calculator
This calculator will aid you in calculating the necessary materials to produce hand sanitizer. HAND SANITIZER CALCULATOR.