Due to the COVID-19 pandemic, most retailers can’t keep up with the demand for hand sanitizer. FDA does not intend to take action against firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs, provided that the following requirements are met.
ITB HOLDINGS LLC has been helping companies around the world register with the FDA and list their hand sanitizers.
Hand sanitizers are over-the-counter (OTC) drug products and must therefore be manufactured based on an FDA Monograph.
■ The hand sanitizer is manufactured using only the following ingredients in the preparation of the product.
- Alcohol (ethanol) that is not less than 94.9% ethanol by volume or United States Pharmacopeia (USP grade) Isopropyl Alcohol
- Glycerin (glycerol) USP or Food Chemical Codex (FCC) (also known as “food grade”)
- Hydrogen peroxide
- Sterile water (by boiling, distillation, or other process that results in water that meets the specifications for Purified Water USP). Water should be used as quickly as possible after it is rendered sterile or purified.
■ The alcohol (ethanol) is denatured either by the alcohol producer or at the point of production of the finished hand sanitizer product.
■ The hand sanitizer is manufactured according to the following formula consistent with World Health Organization (WHO) recommendations.
■ The ethanol or isopropyl alcohol is used as active ingredient in the correct amount.
NATIONAL DRUG CODE (NDC)
LISTING OF HAND SANITIZER
$350.00 SERVICE FEE