Q. Are bioidentical hormones approved and regulated by the FDA?

 

Yes and no.

Compounded bioidentical hormones are not FDA approved due to the customization of each prescription. The FDA does not approve any compounded products for the reason that they are not standardized and prepared on a case-by-case basis. However, the hormones that are used to create compounded bioidentical hormones, which are derived from plants such as soy and yams, are FDA approved hormones that are made in an FDA approved lab. These components are later shipped to a compounding pharmacy to be used in custom-made compounds to fit the needs of each patient. Because each prescription is custom-compounded for each individual patient, FDA approval and regulation is limited. Bioidentical hormones may be delivered in the form of creams, patches, pills, gels, pellets and vaginal rings.

In some cases, BodyLogicMD affiliated physicians will prescribe a non-compounded bioidentical hormone product, when appropriate. Non-compounded bioidentical hormones are FDA approved due to the standardization of each prescription

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