FDA Final Rule on Healthcare Antiseptics

2018-02-27 |

On December 20, 2017, the U.S. Food and Drug Administration (FDA) issued its final rule on safety and effectiveness of topical antiseptics used in healthcare. Here is what you need to know:

  • Proposed rule April 2015
    • FDA requested additional scientific data from manufacturers about the safety and effectiveness of antiseptic products used in healthcare settings.
  • Products addressed by this rule include:
    • Healthcare personnel handwashes and rubs
    • Surgical hand scrubs and rubs
    • Patient preoperative skin preparations, including pre-injection preparations
    • Active ingredients: alcohol and iodine
  • Products not addressed by this rule include:
    • Products containing chlorhexidine gluconate
    • Consumer antiseptic products such as antibacterial hand soap and body washes (addressed in separate proposed rule in 2013)
  • Final rule published December 2017
    • FDA reclassified 24 ingredients as not generally recognized as safe and effective (GRASE) and can no longer be used.
      • Of these ingredients, only triclosan is currently used in healthcare antiseptics
  • FDA deferred action for one year on six additional ingredients to allow manufacturers more time to provide data:
    • Ethanol, isopropyl alcohol, povidone-iodine, benzalkonium chloride, benzethonium chloride, chloroxylenol
  • FDA rule does not impact CDC or WHO hand hygiene guidelines.