The OTC-Drug Monograph Final Rule for Consumer Antiseptic Rubs does not include specific testing requirements for hand sanitizer final formulations. FDA explains that since they do not find any active ingredient(s) to be GRASE (Generally Regarded as Safe and Effective) and thus suitable for inclusion in the Monograph, they will not establish testing requirements for final formulations until such time that GRASE status has been granted to at least one of the three active ingredients currently under consideration.
In the absence of specific testing requirements, one may refer to the Food, Drug and Cosmetic Act and 21 CFR Parts 210 and 211 whereby it is stated that all drug products must satisfy basic requirements for identity, strength, quality and purity. From this, we may surmise what FDA might deem to be suitable testing of hand sanitizer final formulations however it is not a regulatory certainty by any means.
In contrast, FDA has indicated that hand sanitizers manufactured under the Temporary COVID Policy should be free from the impurities listed in their Temporary Policy, and that each batch should be tested to assure its identity (the alcohol listed on the label is the same alcohol in the batch), strength (Assay of the alcohol in the batch conforms to the labeled potency), and purity which many interpret as ‘microbiological purity’ which is demonstrated by conducting USP <61> and <62> Microbial Limits Testing.
It should be noted that the OTC-Drug Monograph Final Rule for Consumer Antiseptic Rubs does discuss testing which includes in vitro Time Kill Studies and also in vivo human clinical studies however this testing is what FDA requires for determining the GRASE status of an active ingredient for inclusion into the Monograph; it is not intended as final formulation testing. Since FDA does indicate specific testing requirements for hand sanitizers manufactured under their Temporary Policy it would be prudent to conduct this same batch testing (at a minimum) for products launched under the OTC Monograph pathway.