FDA proposed rule to address data gaps for certain active ingredients in healthcare antiseptics

FDA proposed rule to address data gaps for certain active ingredients in healthcare antiseptics

FDA proposed rule to address data gaps for certain active ingredients in healthcare antiseptics

FDA has issued a proposed rule to address data gaps for certain active ingredients in healthcare antiseptics.CDC and FDA recommend that healthcare workers continue to use healthcare antiseptic products currently recommended in professional and national guidelines including CDC and HICPAC infection control guidelines and consistent with facility policy.

Questions about the proposed rule should be directed to FDA.

For more information:

•  FDA Press release: “FDA issues proposed rule to address data gaps for certain active ingredients in health care antiseptics”
•  FDA Proposed rule: “Safety and Effectiveness of Health Care Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use”
•  FDA Q&A for Health Care Professionals
•  FDA Q&A for Consumers
•  APIC and SHEA statement on FDA proposed rule