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OTC label redesign costs put at $5,072/SKU by NDMA, 145% higher than FDA projections.

This article was originally published in The Tan Sheet

Executive Summary

OTC LABELING REG: 19% OF OTCs WOULD GO OFF MARKET, NDMA PREDICTS, because they "don't fit" with FDA's proposed labeling requirements for OTC drugs, the association asserts in a Nov. 4 addendum to its comments on the proposed rule. "The majority of [stock-keeping units] that don't fit [with the reg] will be handled administratively," the Nonprescription Drug Manufacturers Association explains. "Nearly 11,000 SKUs will be withdrawn from the market during the two-year implementation period, and an additional 4,000 will be withdrawn as tentative final monographs are finalized," NDMA projects. "Nineteen percent of currently marketed OTC drug SKUs will be taken off the market."
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