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Menopause: February 2016 - Volume 23 - Issue 2 - p 215–223

The Endocrine Society, The North American Menopause Society, American Congress of Obstetricians and Gynecologists, American Society for Reproductive Medicine, and International Menopause Society recommend against CBHT use by anyone without a medical condition preventing them from using FDA-approved HT.32,62,70,78-80 The FDA has also issued caution against compounded drug use.41 Concerns include inadequate evidence of efficacy and safety, variable purity and potency, and insufficient labeling.32,62,70,78-80 The FDA made a statement about CBHT (2008): “FDA is concerned that the claims for safety, effectiveness, and superiority that these pharmacy operations are making mislead patients, as well as doctors and other healthcare professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness. Patients who use compounded hormone drugs should discuss menopausal HT options with their healthcare provider to determine whether compounded drugs are the best option for their specific medical needs.”13The FDA recommends using an approved drug over a compounded one when possible, due to their concerns about safety, efficacy and misbranding, but recognizes that some patients may need a compounded drug when no FDA-approved drug is available to meet their needs.13 The CQA adds §503B and makes clear that §503A now applies throughout the country, removing previous obstacles and impediments to both SPB and FDA enforcement. The new law may improve compliance, accreditation, and monitoring by the compounding industry, support oversight by states and the FDA, and prevent the distribution of misbranded, adulterated, or inconsistently compounded medications, thus reducing the risk to public health.

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