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A clinic should not treat “bioidentical” and “compounded” as interchangeable terms. FDA-approved hormone products can include hormones chemically identical to endogenous hormones, while compounded hormone preparations follow a separate compounding pathway and are not FDA-approved products. FDA has stated it does not have evidence that compounded “bioidentical hormones” are safer or more effective than FDA-approved hormone therapy.
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What should an owner ask before using compounded bioidentical hormones?
Is there an FDA-approved product that fits the intended use? Why is a compounded preparation being considered? Is the prescription patient-specific? Which pharmacy is making it, with what ingredients and concentration? How is it labeled, and how is quality/recall information communicated? What marketing claims is the clinic making?
Owner takeaway
Use “bioidentical” carefully. Know whether you are offering an FDA-approved hormone product, a compounded preparation, or both — and don’t market compounded products as categorically safer or more effective than approved therapy.