On April 12, 2019 FDA issued a Final Rule regarding the OTC Drug Monograph for “Consumer Antiseptics; Topical Antimicrobial Drug Products for OTC Human Use”. With this final rule come several major changes which affect all manufacturers and owners of hand sanitizer products. The major changes found in the final rule are as follows:
FDA has not yet accepted (approved) any Active Pharmaceutical Ingredient (API) for inclusion in the OTC Drug Monograph for Consumer Antiseptic Rubs since suitable information has not yet been submitted which FDA feels will allow them to conclude any as being Generally Regarded as Safe (GRAS) and Generally Regarded as Effective (GRAE).
Of the 31 possible active ingredients which had previously been used or proposed for use in OTC consumer antiseptic rubs, FDA has now ruled 28 ineligible for inclusion in the Monograph. Products containing any of these 28 active ingredients may no longer be placed into interstate commerce starting April 12, 2020.
FDA is deferring action on the 3 remaining API’s (Ethanol, IPA and Benzalkonium Chloride) for use in consumer antiseptic rubs saying they are the only API’s that are eligible candidates for inclusion in the Monograph but that they have still not been officially accepted since their GRAS/GRAE status has yet to be fully demonstrated.
FDA provides testing requirements that sponsors must conduct if they wish to submit data supporting the GRAS/GRAE status of any of the three eligible API’s. This required testing includes:
a. In Vitro testing which includes either Minimum Bactericidal Concentration (MBC) or Minimum Inhibitory Concentration (MIC) and Time-Kill testing using the bacteria specified in the 2016 Proposed Rule (Federal Register Vol.81, No 126 – Thursday, June 30, 2016).
b. In Vivo human clinical testing comprised of 2 pivotal studies each conducted on at least 100 subjects, at two different/independent test sites using both Positive and Negative controls.
FDA does not define any requirements for final formulation testing. The following statement is found in FDA’s response to Comment 10 within the Final Rule:
“In this document (Final Rule), we do not find any active ingredients GRAS/GRAE for use as a consumer antiseptic rub. As a result, this document does not specifically address requirements for anticipated final formulation testing. The testing requirements for finally formulated products containing one of the three deferred active ingredients will be addressed after one or more of the active ingredients are found to be GRAS/GRAE for use in consumer antiseptic rub products.”