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The Endocrine Society's 2016 position statement states that "custom-compounded bioidentical hormones are not FDA approved, and their safety and efficacy have not been evaluated in clinical trials." [7] FDA-approved estradiol and progesterone products, such as Estrace (estradiol 0.01% cream) and Prometrium (micronized progesterone 100 mg and 200 mg capsules), have undergone the full new drug application process

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