Before COVID 19 outbreak most of the hand sanitizers were marketed under the tentative final OTC monograph. On April 12, 2019 FDA issued the final rule, stating only three ingredients namely Ethyl alcohol, Benzalkonium chloride and Isopropyl alcohol are considered under the OTC monograph. As per FDA’s press announcement dated April 11, 2019, “At this time, the FDA does not intend to take action to remove hand sanitizers containing these three active ingredients from the market”.
Further, the FDA has developed a Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry” which allows non-drug manufacturing companies to produce alcohol based hand sanitizers during the COVID 19 emergency.
Upon completion of registration and listing, firms receive automatic confirmation from the FDA and do not need to wait for further communication from FDA before they begin to manufacture and distribute these products.