Effective December 2017, triclosan can no longer be used as an active ingredient in hand hygiene products used in healthcare settings, according to the FDA.
|On December 19, 2017, the Food and Drug Administration (FDA) released a final ruling that Triclosan, an antibacterial and antifungal agent, cannot be used as an active ingredient in hand hygiene products used in healthcare settings. This triclosan ban is industry wide.|
|This finalizes a rule first proposed in 2015 that finds that triclosan is not generally recognized as safe and effective for use in over-the-counter (OTC) healthcare antiseptic products – including healthcare personnel hand washes and rubs, surgical hand scrubs and rubs, and patient antiseptic skin preparations.1|
|Manufacturers have until December 20, 2018, to stop the manufacture and distribution of products containing triclosan, or reformulate those soaps.|
|This action only concerns OTC products that are commonly marketed to healthcare providers and used primarily in medical settings like hospitals, health care clinics, and doctors’ offices.|
All healthcare providers, including public health clinics, medical practices, surgery centers, skilled nursing and nursing homes, home health agencies, imaging centers and dental clinics.
Key Dates for the FDA Ban on Triclosan
December 19, 2017
FDA issues final ruling banning triclosan from hand hygiene products used in the healthcare setting
December 20, 2018
Manufacturers must cease the manufacture and distribution of hand hygiene products containing triclosan
Why is this happening?
The ruling is part of the FDA’s ongoing, comprehensive review of OTC antiseptic active ingredients to ensure these ingredients are safe and effective. The FDA previously mandated the ban of triclosan products across the consumer market in 2016.
Most currently marketed healthcare antiseptics are not impacted by this final rule. The FDA has deferred final rule-making on six specific active ingredients that are the most commonly used in currently marketed OTC healthcare antiseptic products – alcohol (ethanol), isopropyl alcohol, povidone-iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol (PCMX) – to provide manufacturers with more time to complete the scientific studies necessary to make a safety and efficacy determination about these ingredients.2
“Ensuring the safety and effectiveness of over-the-counter health care antiseptics has been a priority for the FDA, not only because these products are an important component of infection control strategies in health care settings, but also because of the role these products may play in contributing to antimicrobial resistance if they’re not manufactured or used appropriately.” — FDA Commissioner Scott Gottlieb, M.D.
How should you prepare?
These regulatory changes may force your facility to transition to a new hand soap. CDC and WHO guidelines allow the use of either antimicrobial or non-antimicrobial soap. Antimicrobial soaps provide the greatest risk reduction and have a history of safe use in healthcare settings.
What are your replacement options?
- Replace the impacted hand hygiene product(s) you’re currently ordering with a non-medicated equivalent
- Replace with a different active ingredient (i.e., PCMX or BZM)
- Replace with a CHG-based soap
The chart below maps McKesson Brands soaps to their compliant, triclosan-free replacements.
*FE indicates a functional equivalent; CE indicates a clinical equivalent.
You are also encouraged to practice proper hand-washing technique to help avoid getting sick and help prevent your facility personnel from spreading germs to others. The CDC recommends an alcohol-based hand sanitizer containing at least 60% alcohol.3
Visit UPrevent to learn more about hand hygiene guidelines and recommendations and to access valuable resources, infection prevention materials and more.Visit UPrevent
Additional Resources for Healthcare Providers
FDA Ruling: Safety & Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
Be advised that information contained herein is intended to serve as a useful reference for informational purposes only and is not complete clinical information. This information is intended for use only by competent healthcare professionals exercising judgment in providing care. McKesson cannot be held responsible for the continued currency of or for any errors or omissions in the information.