FDA Rule on Healthcare Antiseptics

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.