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
oFDA requested additional scientific data from manufacturers about the safety and effectiveness of antiseptic products used in healthcare settings.
Products addressed by this rule include:
oHealthcare personnel handwashes and rubs
oSurgical hand scrubs and rubs
oPatient preoperative skin preparations, including pre-injection preparations
oActive ingredients: alcohol and iodine
Products not addressed by this rule include:
oProducts containing chlorhexidine gluconate
oConsumer antiseptic products such as antibacterial hand soap and body washes (addressed in separate proposed rule in 2013)
Final rule published December 2017
oFDA 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:
oEthanol, isopropyl alcohol, povidone-iodine, benzalkonium chloride, benzethonium chloride, chloroxylenol
FDA rule does not impact CDC or WHO hand hygiene guidelines.