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FDA "tentative final monograph for over-the-counter topical antiseptics"
Hello, my company is manufacturing hand sanitizers POST PANDEMIC (so not under temporary guidance that’s expired Dec. 2021) and we are wondering if the quote “tentative final monograph for over-the-counter topical antiseptics” is referring to the monograph that was made effective April 2020? This would no longer be tentative (see effective date) but that quote is what’s used in every source as the “to do” rules since the temporary order was rescinded. I have the link of what I think is the current Final Monograph here. Looking for guidance on the most current post pandemic regulations, or clarity on if it reverted back to the original monograph.
https://www.govinfo.gov/content/pkg/FR-2019-04-12/pdf/2019-06791.pdf
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3 Replies
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Here is the overall history of this and related monographs https://www.fda.gov/drugs/historical-status-otc-rulemakings/rulemaking-history-otc-topical-antimicrobial-drug-products#Consumer_Antiseptic.
The FR citation you offered addresses only one of these topical antimicrobial product monographs, specifically
This document covers only OTC
consumer antiseptic rubs that are
intended for use without water. This
document does not cover consumer
antiseptic washes (78 FR 76444, 81 FR
61106); healthcare antiseptics (80 FR
25166, 82 FR 60474); antiseptics
identified as ‘‘first aid antiseptics’’ in
the 1991 First Aid tentative final
monograph (TFM) (56 FR 33644); or
antiseptics used by the food industry.The FR offers a CDER contact person - Anita Kumar, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5445,
Silver Spring, MD 20993–0002, 301–
796–1032. You’ve best advised to contact Ms. Kumar. -
Dr. Phil gave you the Big Picture there, so I can distill down to the little picture. Look at the CFR file [2016-15410, pp 42918] which is still valid today. Use the monograph limits for ethanol or isopropanol or BKZ, although ethanol is the most effective, least expensive, easiest to work with and most consumer acceptable active to use. BKZ has issues with P. aeruginosa (and @PhilGeis might correct me on that one) resistance, whereas the alcohols do not. Our company is the originator of Rapidgel EZ1, the drop-in alcohol thickener, for which sales went crazy when hand sanitizers sales did same, so we have a LOT of research on this. My beef with the TFM - and I always smile at that oxymoron - is their dismissal of chloroxylenol (PCMX), although it is still allowed in washes/ liquid soaps. PCMX has been safely in use since the 1920’s, has been proven not to be a contributor to MIRSA, is 60X more effective than phenol…I could go on. Triclosan, triclocarban, hexachlorophene and all the others (including dioxin!) have come and gone with dishonor, but PCMX maintains its rightful place in antiseptic formulation.
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As always chemicalmatt is spot on. BKZ is so lame that Pseudomonas grows in the stuff
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