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What is the difference between FDA approved HRT and compounded HRT?Updated 3 months ago

There are FDA-approved bio-identical and synthetic hormones, that are commercially manufactured by pharmaceutical companies following strict regulatory guidelines. They are manufactured as standardized medications with precise dosages and forms (meaning they do not allow for customization). 

This type of hormone therapy is only offered by prescription and is typically covered by insurance. FDA-approved hormone products also undergo rigorous testing (often involving trials with large groups of patients) and are known to be consistent in terms of dosing and quality.

Compounded hormones are mixed and prepared by compounding pharmacies, which are not subject to the same rigorous regulatory oversight as pharmaceutical manufacturers. The FDA does not approve compounded hormone products, meaning they have not undergone the same level of safety and efficacy testing as FDA-approved drugs. Compounded hormones are typically not covered by insurance and must be paid for out of pocket.


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