15/16 June 2023
In December 2013, the FDA issued a proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. It was proposed to establish conditions under which OTC consumer antiseptic products intended for use with water (generally referred to as consumer antiseptic washes) are generally recognized as safe and effective. Due to the ongoing scientific developments the FDA considered that new safety data should be evaluated for some products which were evaluated in 1994 as save for the use by consumers. Then, in 2016, the FDA issued a final rule on "Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use" . They summarized:
"The Food and Drug Administration (FDA, we, or the Agency) is issuing this final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water (referred to throughout this document as consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded. FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC); public comments on the Agency's notices of proposed rulemaking; and all data and information on OTC consumer antiseptic wash products that have come to the Agency's attention. This final rule amends the 1994 tentative final monograph (TFM) for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA."
Now, in July 2017, the authority published an additional "Guidance for Industry Consumer Antiseptic Wash Final Rule - Questions and Answers". This new document is supposed to give guidance to small businesses for a better understanding and for complying with the final rule from 2016. This final rule and the additions are part of FDA's ongoing rulemaking to evaluate the safety and effectiveness of OTC drug products marketed in the United States on or before May 1972 (OTC Drug Review). Nineteen ingredients were subject of the final rule: cloflucarban, fluorosalan, hexachlorophene, hexylresorcinol, Iodophors (Iodine-containing ingredients), iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate), Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol), nonylphenoxypoly (ethyleneoxy) ethanoliodine, poloxamer-iodine complex, povidone-iodine, undecoylium chloride iodine complex, methylbenzethonium chloride, phenol4, secondary amyltricresols, sodium oxychlorosene, tribromsalan, triclocarban, triclosan and triple dye. This will affect up to 2100 products in the hand and body wash market.