In Brief: OTC anticaries monograph
This article was originally published in The Tan Sheet
Executive Summary
OTC anticaries monograph: Series of five related citizen petitions requesting changes to the final monograph on anticaries products were filed jointly April 17 by the Nonprescription Drug Manufacturers Association and the Cosmetic, Toiletry and Fragrance Association. The petitions seek action requested by CTFA/NDMA in an April 3 OTC "feedback" meeting with FDA ("The Tan Sheet" April 8, p. 8). The petitions request: clarification of the use of the term "gel"; a 12-month effective date extension for new biological testing requirements; exemptions from poison control warnings for certain dentifrice products; and an amendment to the professional dosage schedule for fluoride supplementation...
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