By Riëtte van Laack — As previously discussed, pursuant to a consent decree, FDA was to finalize the over-the-counter (OTC) topical health care antiseptic drug products monograph with respect to triclosan by January 15, 2018. Rather than limiting the rulemaking to the single active ingredient, triclosan, FDA took it upon itself to finalize the monograph for all OTC health care antiseptic active ingredients. Ahead of time, on Dec. 20, 2017, FDA issued what it identifies as the final rule for health care antiseptics. Upon further reading, it turns out that FDA is not yet done, however. The final rule constitutes a final determination that 24 active ingredients are not generally recognized as safe and effective (GRASE); they are added to the list of unapproved new drugs in 21 C.F.R. § 310.545. The compliance (or effective) date is Dec. 20, 2018. On or after that date, any OTC health care antiseptic drug product that contains any of…
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