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US FDA Patient Medication Information Proposed Rule May Be Coming Soon

Executive Summary

A proposal for a new form of patient labeling, which has been in the works for decades, may finally be coming to fruition despite the FDA missing a December 2022 target date listed in HHS’ semi-annual regulatory agenda.

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Manufacturers would have full responsibility for writing, producing, and ultimately delivering the new patient medication information document with their products, if FDA decides the industry should fully adopt the unit-of-use packaging.


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