Amid the novel coronavirus outbreak COVID-19, we are getting many questions about FDA requirements for hand sanitizers and other questions related to FDA regulations for hand sanitizers.
On 24th April 2019 FDA published final rule stating that the three active ingredients namely benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are the only active ingredients determined to be eligible for evaluation under the OTC Drug Review for use in OTC consumer hand sanitizers.
At this time, three active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are being deferred from further rulemaking to allow for the ongoing study and submission of additional safety and effectiveness data necessary to determine whether these active ingredients are generally recognized as safe and effective for use in OTC consumer antiseptic rub products. Their status will be addressed either after completion and analysis of the studies or at another time if these studies are not completed. At this time, the FDA does not intend to take action to remove hand sanitizers containing these three active ingredients from the market.
To market over-the-counter drug (OTC monograph) products such as hand sanitizers, you should comply with the requirements listed below.
It will take about 10 business days to obtain the labeler code from the FDA. After receipt of the labeler code, drug listing can be completed within two business days.
You may not need FDA inspection before selling over the counter monograph products, however, the FDA may inspect manufacturing facilities anytime to verify the compliance to Good Manufacturing Practice.
It remains manufacturer /labeler responsibility scientific rationale data safety and effectiveness of the product.
If you have any questions related to GMP compliance, please contact us.
FDAbasics offers services to comply with FDA requirements for hand sanitizers, please contact us for more information.
Active ingredients published in the final rule
(a) Alcohol (ethyl alcohol) 60 to 95 percent by volume in an aqueous solution denatured according to the Treasury Department’s Bureau of Alcohol, Tobacco, and Firearms regulations at 27 CFR 212.
(b) Isopropyl alcohol 70 to 91.3 percent by volume in an aqueous solution.
If you are planning to market hand sanitizers, antibacterial or antibacterial hand wash products, FDAbasics can help you to comply with FDA requirements. Please contact us for more information.
FDA has published a temporary policy for alcohol-based sanitizer, click here for more details.
This article reflects the current understanding of FDAbasics LLC, does not constitute legal bindings.BACK