The FDA has withdrawn all three guidance documents which allowed distilleries to produce and distribute hand sanitizer as an emergency measure during the pandemic. Production should have ceased December 31st, 2021, and distribution by March 31st, 2022*. It is also important to be sure you de-register from the FDA’s OTC monograph system if you registered to produce hand sanitizer under the now withdrawn guidance.
How do I de-register?
FDA is sharing training and additional resources below to assist in submission questions.
To de-register using CDER Direct:
- Open the previously submitted and accepted Establishment Registration
- Click Create New Version
- Change the document type to Establishment De-Registration and Submit SPL.
*After March 31, 2022, only hand sanitizer products prepared in compliance with all applicable requirements, including the tentative final monograph for over-the-counter topical antiseptics, as amended, may be distributed by manufacturers.