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.