The manufacturing firm is required to keep a record of the key steps and controls to ensure that each batch is manufactured using the correct formula, and the correct amount of active ingredient and alcohol.
The hand sanitizers must be manufactured under sanitary conditions using equipment that are fit for use.
The manufacturing firm must use accurate analysis methods to verify the alcohol content in the samples of the finished product before the batches are distributed for use. Analysis methods used for verification may include gas chromatography (GC), alcoholmeter, hydrometer, or other chemical analysis of at least equivalent accuracy.
Labeling of hand sanitizers must align with the following: Appendix A (Labeling for Ethyl Alcohol Formulation Consumer Use), Appendix B (Labeling for Isopropyl Alcohol Formulation Consumer Use), Appendix C (Labeling for Ethyl Alcohol Formulation Health Care Personnel Handrub Use), or Appendix D (Labeling for Isopropyl Alcohol Formulation Health Care Personnel Handrub Use).
Hand sanitizer manufacturing firms are also required to register themselves with the FDA through the Drug Registration Listing System. Once the registration and listing is completed, the firm receives a confirmation from the FDA, post which they can begin to manufacture and distribute their products.
