Fluoride dentifrices
This article was originally published in The Tan Sheet
Executive Summary
U.S. Pharmacopeia fluoride-containing dentifrice reference standards should be used to test for stability every 18 months, FDA, USP and industry reps concluded at a May 20 FDA OTC feedback meeting. Companies then should submit new samples to replace those found to be unstable, but are not required to submit new reference standards for formulas no longer used, such as sodium fluoride/calcium pyrophosphate. FDA expects to publish the OTC anticaries drug products final monograph in six to 12 months.