The Food and Drug Administration and the Alcohol and Tobacco Tax and Trade Bureau (TTB) have both recently issued guidance documents to allow for the increased production of alcohol-based hand sanitizer during the COVID-19 outbreak.
The FDA issued two guidance documents to increase the supply of alcohol-based hand sanitizers. The first indicates that FDA will not take action against manufacturing firms that produce alcohol-based hand sanitizers for consumers and healthcare workers. The second allows pharmacists to compound alcohol-based hand sanitizers without a patient-specific prescription.
The guidance only applies to production that uses the United States Pharmacopoeia or Food Chemical Codex grade ingredients listed in the guidance. There is also additional information about product labeling, manufacturing methods, and reporting requirements as Drug Registration and Listing System (DRLS) information will have to be prepared and submitted to FDA.
The TTB announced that the agency is allowing distilled spirits permittees (DSPs) and alcohol fuel plants (AFPs) to more easily participate in the hand sanitizer market as well. DSPs do not have to obtain authorization to produce hand sanitizer or distilled spirits for use in hand sanitizer. AFPs and beverage DSPs are also exempted from obtaining additional permits or bonds to manufacture hand sanitizer or supply ethanol for other TTB permittees to manufacture hand sanitizer. AFPs and beverage DSPs must continue to maintain records of their operations. Many states have announced similar flexibility for distilled spirits manufacturers, but manufacturers should check with their local licensing authority prior to supply ethanol for or producing hand sanitizer.
Husch Blackwell is experienced navigating the regulatory requirements of FDA and TTB. Our FDA and Alcohol and Beverage lawyers are available to discuss these developments and how companies can a comply with this new guidance, including the preparation of DRLS information that will have to be submitted to FDA as well as navigating state and federal alcohol beverage requirements. Contact Seth Mailhot, Emily Lyons, or your Husch Blackwell attorney.