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Compounded Hormone Therapies Lack Evidence Of Safety And Effectiveness, Say National Academies

Executive Summary

The US Food and Drug Administration should require that outsourcing facilities collect bioavailability data for compounded bioidentical hormone replacement therapy products, while compounding pharmacies should be required to report adverse events to state pharmacy boards and the FDA. Such actions would help resolve some of the safety concerns for these products, says a 1 July report from the National Academy of Sciences, Engineering and Medicine.

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