On December 19, 2017, the United States Food and Drug Administration has finalized a rule, first proposed in 2015, regarding use of Triclosan and 23 other active ingredients, not generally recognized as safe and effective (GRASE), in over-the-counter (OTC) healthcare antiseptic products like hand washes and rubs, surgical hand scrubs and rubs, and patient antiseptic skin preparations used by healthcare personnel.
As no additional safety and effectiveness data were provided to the FDA to support monograph conditions for these 24 active ingredients1, the FDA has ruled that products containing these active ingredients, intended for use in OTC healthcare antiseptics by health care professionals in a hospital setting or in other health care situations outside the hospitals, are not allowed to be marketed without undergoing pre-market review. Healthcare antiseptic drug products containing one or more of these non-GRASE active ingredients will be considered new drugs for which approved new drug applications (NDAs) are required for marketing. Manufacturers will have one year to comply with this final rule either by reformulating (revising or changing formulas) their products or removing them from the market. Based on the rule, manufacturers have already started removing these ingredients from their products. Of the 24 active ingredients listed by the FDA as non-GRASE, Triclosan is the only active ingredient currently being used in any marketed healthcare antiseptic product. Therefore, most healthcare antiseptics, currently marketed, will not be impacted by this final rule.
Speaking on this matter, the FDA Commissioner Scott Gottlieb said that "Ensuring the safety and effectiveness of over-the-counter healthcare 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." The final rule has been published in the Federal Register of the United States titled as "Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use2."
Final Rule Covers Only Healthcare Antiseptics
The final rule describes 'Healthcare Antiseptics' as "drug products that are generally intended for use by healthcare professionals in a hospital setting or other healthcare situations outside the hospital. Patient antiseptic skin preparations, which are products that are used for preparation of the skin prior to surgery (i.e., preoperative) and preparation of skin prior to an injection (i.e., pre-injection), may be used by patients outside the traditional health care setting. Some patients (e.g., diabetics who manage their disease with insulin injections) self-inject medications that have been prescribed by a healthcare professionals for use at home or at other locations and use patient preoperative skin preparations prior to injection".
In this final rule, the term 'healthcare antiseptics' includes the following products:
- Hand washes for Healthcare personnel
- Hand rubs for Healthcare personnel
- Surgical hand scrubs
- Surgical hand rubs
- Patient antiseptic skin preparations (i.e., patient preoperative and pre-injection skin preparations)
Footnotes
1 https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm589474.htm
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