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OTC label disclaimer for nonconforming small packages suggested by NDAC.

This article was originally published in The Rose Sheet

Executive Summary

OTC LABEL 6-POINT TYPE SIZE MINIMUM STANDARD WITH FLEXIBILITY for smaller containers and packages recommended by FDA's Nonprescription Drugs Advisory Committee during a July 14 meeting on the agency's proposed rule on OTC label reform in Bethesda, Md. The eight voting members of the committee unanimously agreed that the agency should "attempt to use the 6-point [type size] as the standard and that any modification from that be evaluated to ensure readability is preserved." The motion was proposed by NDAC member Eric Brass, MD/PhD, Harbor-UCLA Medical Center.



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