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OTC Label Exemptions With "Consistency In Format" May Be Allowed - FDA

This article was originally published in The Rose Sheet

Executive Summary

Exemption requests from the OTC labeling rule may deviate from elements of the final requirements if they are consistent with the general format outlined in the reg, FDA's ODE V Director Robert DeLap, MD/PhD, said at a working group meeting on the issue in Rockville, Md. Sept. 17.
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