FDA issues final rule on 23 ingredients in over-the-counter antiseptic products: 5 key notes

The FDA finalized a rule that over-the-counter healthcare antiseptic products containing triclosan and 23 other active ingredients may not be marketed without undergoing pre-market review. A rule first proposed in 2015 found that these active ingredients are not generally recognized as safe and effective.

Here are five things to know:

1. Healthcare antiseptic drug products containing one or more of these non-GRASE active ingredients will be considered new drugs for which approved new drug applications are required before marketing. Manufacturers have one year to comply with this rule by reformulating or removing their products from the market.

2. Of the 24 active ingredients the FDA finds non-GRASE, triclosan is the only active ingredient currently used in any marketed healthcare antiseptic product. Most currently marketed healthcare antiseptics, such as personnel hand washes and rubs, surgical hand scrubs and rubs and patient antiseptic skin preparations, will not be impacted by this rule.

3. In response to industry requests, the FDA has deferred final rulemaking for a year on six active ingredients most commonly used in currently marketed over-the-counter healthcare antiseptic products. The ingredients are:

  • Ethanol
  • Isopropyl alcohol
  • Povidone-iodine
  • Benzalkonium chloride
  • Benzethonium chloride
  • Chloroxylenol (PCMX)

The deferral is intended to give manufacturers more time to complete studies so that the FDA can make a safety and efficacy determination about these ingredients.

4. The final rule does not affect healthcare antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.

5. This final rule is part of the FDA's ongoing review of over-the-counter antiseptic active ingredients. The FDA has previously issued a proposed rule on consumer antiseptic rubs in June 2016 and a final rule on consumer antiseptic washes in September 2016.

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