On September 6, 2016, the FDA published a final rule on the use of certain active ingredients which were proposed for inclusion in the OTC consumer antiseptic washes commonly referred to as hand and body antibacterial washes.

Under this final rule the ingredients listed here can no longer be used in over-the-counter drug products unless there is a new drug application approved by the FDA. In order to provide the industry with a reasonable period for compliance, the agency has provided a one-year grace period for manufacturers to get into compliance and either reformulate their products or change the product labeling so that the product no longer makes drug claims. Products shipped after September 5, 2017, will have to comply with this final rule.

This final rule on antibacterial hand washes is not a surprise. In 2013, and as a result of litigation brought by an activist group, the FDA in a notice of proposed rule-making, announced that it would now require additional data to support all the ingredients proposed for inclusion in the monograph. The request for data made at that time reflected a change in position by the FDA on the nature of the data required to prove efficacy, the agency changed its standard from a bacterial kill standard to a requirement to prove clinical significance, through a showing of reduced infections. This now required the submission of robust clinical data which was not submitted by the manufacturers of the 19 ingredients that have now been excluded from the monograph.

We will have to wait and see whether the data submitted by the manufacturers of the three remaining ingredients will prove sufficient. Until the agency makes a final determination on these three ingredients, marketers who are using these three ingredients can continue to market products under the monograph.

Read the full text of the FDA's final rule.