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Ingredient listing changes under FDA reform may be deferred until OTC label regs effective.

This article was originally published in The Tan Sheet

Executive Summary

OTC LABELING INGREDIENT LISTING CHANGES UNDER FDA REFORM MAY BE DEFERRED until companies bring their labeling into compliance with the agency's pending final rule on OTC drug labeling, the Center for Drug Evaluation & Research says in a guidance for industry issued Feb. 20. The FDA Modernization Act requires the name and quantity of each active and inactive ingredient appear on OTC drug labeling. Inactives must be listed on the outside container and, if deemed necessary, on the immediate container as well. If the OTC is not a "cosmetic-drug" (sunscreen, acne product, dandruff shampoo or antiperspirant/deodorant), the inactives must be listed in alphabetical order.

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