mdi ConsultantsAs of June 29, 2016, FDA has started collection of additional safety and effectiveness data for certain active ingredients present in over-the-counter (OTC) consumer antiseptic rubs. The consumer antiseptic rubs include hand sanitizers and antiseptic wipes that are intended to be left on and not rinsed off with water. These products are used by consumers when soap and water are not available.
In this June 29, 2016 Proposed Rule to amend the 1994 tentative final monograph for OTC antiseptic drug products, FDA requested manufacturers to provide data for three active ingredients:
- alcohol (ethanol or ethyl alcohol)
- isopropyl alcohol
- benzalkonium chloride
Since the FDA began review of topical antiseptics in the 1970’s, many things have changed, including the frequency of use of some of these products, new technology that can detect low levels of antiseptics in the body, and the FDA’s safety standards and the scientific knowledge about the impact of widespread antiseptic use.
The latest available scientific data and emerging science suggest that systemic exposure to some antiseptic active ingredients, as shown by detection of antiseptic ingredients in the blood or urine, is higher than previously thought. More information is needed about the effects of repeated daily human exposure to some antiseptic active ingredients.
Accordingly, the Agency requested additional scientific data to demonstrate that the active ingredients used in consumer antiseptic rubs are generally recognizes as safe and effective to reduce bacteria on skin. The FDA wants to ensure that regular use of these products does not present unknown safety and efficacy concerns, however this proposed ruling does not mean the FDA believes these products are ineffective or unsafe. Specifically, FDA is interested in additional data on the long-term safety of daily, repeated exposure to these ingredients by consumers, and on the use of these products by children and pregnant women.
The industry will have one year to submit new data and information may then be submitted to the docket for an additional 60 days. The FDA will then evaluate the data and comments received in response to this proposal. The FDA’s final determination will be published as a final rule (final monograph).
If FDA does not receive sufficient data from the industry to support OTC monograph for consumer antiseptic rub products containing ethanol, ethyl alcohol, isopropyl alcohol and benzalkonium chloride, these active ingredients may not be included in the future OTC consumer antiseptic rub final monograph. Such non-monographed consumer antiseptic rubs could seek approval to market by submitting new drug applications (NDA’s).
The proposed rule does not require any consumer hand sanitizer products to be removed from the market at this time.
InecFor more information about the topic and the types of safety and effectiveness studies required by FDA, please visit Safety and Effectiveness of Consumer Antiseptics
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