Before you export any hand sanitizer to the United States, register your establishment with the U.S. Food and Drug Administration (U.S. FDA), to avoid the detention of your shipment.
Could your company help meet the rapid surge in demand worldwide? The global hand sanitizer market size valued at $2.7 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 22.6% from 2020 to 2027.
ITB HOLDINGS LLC helps domestic and foreign companies that are manufacturers, exporters, importers, or distributors of hand sanitizers register their establishment, and list their products.
■ Because hand sanitizer is regulated by the FDA as an over-the-counter (OTC) drug product, your company will need a Drug Establishment Registration.
Such registration requires a DUNS (Data Universal Numbering System, abbreviated as DUNS or D-U-N-S) Number assigned by Dun & Bradstreet Inc. DUNS Number is free. Obtaining it in less than 30 days is possible for a fee.
Your hand sanitizer must be manufactured in compliance with an FDA Monograph.
- 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 formula consistent with World Health Organization (WHO) recommendations.
■ The ethanol or isopropyl alcohol is used as active ingredient in the correct amount.
All sanitizers must have a standard Drug Facts label. Label Review is available, when requested.
Hand Sanitizer Manufacturers are currently exempt from new Over-the-Counter Monograph Drug User Fees. But, that could change soon.