The Proposed Rule based on the Tentative Final Monograph (TFM) (here) is a 101-page monster that addresses consumer-type hand rubs that are designed to be used without water – generally, what one might think of as “hand sanitizers” (or “consumer antiseptic rubs” as the FDA terms them).  The Proposed Rule DOES NOT cover “OTC consumer antiseptic washes and OTC antiseptics intended for use by health care professionals in a hospital setting or other health care situation outside the hospital are GRAS/GRAE.”

In the document, FDA is proposing additional efficacy and safety information to support GRAE/GRAS determinations for such products.  FDA notes that the new information requests come from its experience over time, largely other panel reports from 2005, that have prompted a review of provisions of the TFM, which issued in 1994.  FDA notes that final formulation testing may include absorption data to support safety (as it is now known that these products are absorbed to a greater extent than previously thought), and there is also an issue relative to bacterial resistance (but according to FDA only for benzalkonium chloride. See below for the three ingredients covered), as well as in vitro data to support effectiveness (additional microbial log reduction data, as well as data relative to the frequency of use and the volume of product that should be used).  Thus, as the Agency now states, “[T]he benefits of any active ingredient will need to be weighed against its risks once both the effectiveness and safety have been better characterized to determine GRAS/GRAE status.”  These aspects are important because consumers tend to use these products over prolonged periods of time.

FDA is evaluating three products under this Proposed Rule: alcohol (ethanol or ethyl alcohol), isopropyl alcohol, and benzalkonium chloride.  While alcohol was originally designated as GRAS/GRAE in the 1994 TFM and the other two ingredients were given Category III designations indicating that additional data was necessary to support such a determination, FDA is now requesting additional data on all three ingredients.

FDA is giving this Proposed Rule a 180-day comment period due to the complex questions raised and, depending on the time necessary to conduct required studies, FDA may “defer further rule making for a particular active ingredient” if the request is made during the initial 180-day comment period.  Anyone seeking to market or continues to market any one of these products should familiarize themselves with the Proposed Rule and be prepared to provide the requested data to support the general recognition of safety and effectiveness that may be needed.  There is a lot of work that must be done before a Final Rule is published.  Remember that FDA is not asking that any hand sanitizer come off the market at this time, which is consistent with the monograph process; that is, a product can continue to be marketed under a TFM or Proposed Rule until a Final Rule is published.