Back on April 11, 2019, we posted on the Consumer Antiseptic Rubs Final Rule (here), which also addressed use of certain wipes. The notice excluded 28 active ingredients from inclusion for OTC use as consumer antiseptic rubs (for example, leave on products, not to be used with water) but deferred action on three ingredients, “benzalkonium chloride, ethyl alcohol, and isopropyl alcohol–to allow time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients”. The Agency intends to review the status of these three ingredients as the new OTC administrative process rolls out. Until then, these three ingredients can continue to be marketed in accordance with the other proposed monograph requirements.
The newly issued Q&A Guidance document answers questions for the industry on how to comply and what firms can and cannot do until the only three ingredients currently permitted to be marketed during the deferral period is resolved by industry submissions and subsequent Agency evaluation. The guidance notes that labeling will be addressed once and if the Agency determines the deferred ingredients are generally recognized as safe and effective (GRAS/GRAE). And while not much has changed from the April 2019 FR Notice, this guidance does provide some useful information, and can be found here.
Oh, by the way, this will be the last blog post this year. We at Lachman Consultants wish you a happy and healthy New Year, and may 2021 bring us all a brighter time.
