Compounded bioidentical hormone products are not FDA-approved and should not be described as inherently safer, more natural or more effective than approved hormone therapy.

Compounded Bioidentical Hormone Therapy

“Bioidentical hormone therapy” can refer to different products, including FDA-approved hormone medicines and compounded preparations. The terms should not be used as a shortcut for safety, effectiveness or regulatory status.

FDA-approved vs compounded hormone products

FDA states that many marketed products described as compounded “bioidentical hormones” are not FDA-approved. FDA does not have evidence that compounded bioidentical hormones are safer or more effective than FDA-approved hormone therapy. FDA-approved hormone products have undergone review for their approved uses, while compounded drugs are not reviewed by FDA before marketing for safety, effectiveness or quality.

When a compounding question may arise

Compounding can serve an important medical need when an appropriate FDA-approved drug cannot meet a patient's needs. A compounded hormone prescription should therefore be tied to the prescriber's individualized clinical decision and a specific formulation need, not to a general claim that compounded hormones are superior.

Questions for the prescriber and pharmacy

• What hormone or hormones are prescribed?
• Is there an FDA-approved product that meets the clinical need?
• If compounding is prescribed, what specific formulation need is being addressed?
• What dosage form and ingredients are specified in the prescription?
• What are the current cost and prescription-processing details?

For general compounding information, see Prescription Compounding. For a current prescription or formulation question, use Contact Access Care Pharmacy.