FDA published a Final Rule (here), finding that 24 ingredients in the proposed monograph, “Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,” are not considered, or generally recognized, as safe and effective (GRAS/GRAE) for OTC use. However, as noted in the Rule, the FDA has deferred regulatory action on 6 active ingredients: benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol (also referred to as ethanol or ethyl alcohol), isopropyl alcohol, and povidone-iodine, which will be addressed as further information becomes available and is reviews by the Agency.
The Final Rule has an effective date of December 20, 2018, which means that firms will have a one-year grace period to reformulate their products or remove the products from the market. A little anticlimactic is the fact that only 1 (triclosan) of the 24 ingredients that the FDA will not classify for GRAS/ GRAE status is still found in any of the marketed OTC products. Of course, since this rule making is for OTC marketed products, a firm could always submit an application under 505(b)(1) or (2) or support the safety and effectiveness of the product.
FDA discusses new safety information regarding potential higher systemic absorption than previously thought (based on new analytical methods) that could impact public health. They also discuss the problem of continued use of those products and the impact on the development of bacterial resistance.
The Agency further notes that “this final rule also addresses comments on the eligibility of three active ingredients – alcohol (ethyl alcohol), benzethonium chloride, and chlorhexidine gluconate—and finds that these three active ingredients are ineligible for evaluation under the OTC Drug Review for certain health care antiseptic uses because these active ingredients were not included in health care antiseptic products marketed for the specified indications prior to May 1972. To our knowledge, there is only one ineligible product currently on the market, an alcohol-containing surgical hand scrub, which is affected by this rule.”
The Federal Register Notice contains a nice summary of the regulatory history and findings of the review on all the ingredients, as well as the process used in the FDA’s final determinations. Take a peek at the 107 page rule to see the 24 ingredients and find out what the skinny is on these products to be used on the skin.
