FDA hand sanitizer regulations and registrations: Alcohol based Hand sanitizers fall under the category of OTC monograph drugs based on the kind of active ingredients according to FDA regulations. There are few simple steps involved in registration of hand sanitizers. The manufacturer or labeler (brand owner) has to first register their establishment. A US agent has to be identified during this initial process and a DUNS number is mandatory for proceeding further with the registration. Along with the registration a label code application has to be submitted.
Once establishment registration is completed the FDA issues the first 5 digits of the NDC Labeler Code. The Manufacturer then has to ensure the drug information and label provided are accurate and comply with FDA regulations. The establishment must list all drug types and packaging sizes that they plan to market/distribute in the US. The establishment must also make sure to follow all FDA label compliance.