Compounded Menopausal Hormone Therapy Questions and Answers
Pharmacy Compounding Menopausal Hormone Therapy and “Bio-identical” Hormones
FDA’s Enforcement Action Against Compounded “BHRT” drugs
FDA’s Response to Wyeth’s Citizen Petition
FDA’s Enforcement Action Against Compounded “BHRT” drugs
FDA’s Response to Wyeth’s Citizen Petition
Pharmacy Compounding
1. What is pharmacy compounding?
FDA regards traditional pharmacy compounding as the combining or altering of ingredients by a pharmacist, in response to a licensed practitioner’s prescription, to produce a drug tailored to an individual patient’s special medical needs. In its simplest form, traditional compounding may involve reformulating a drug, for example, by removing a dye or preservative in response to a patient allergy. In the case of menopausal hormone therapy, an FDA approved progesterone product contains peanut oil. Progesterone compounded without peanut oil in response to a prescription for a specific patient who is allergic to this ingredient might allow the patient to safely use the drug.
2. Is combining two or more drugs considered compounding?
FDA would consider the combining of two or more FDA-approved drugs into a single medication, in a manner not described in a drug’s FDA-approved labeling, to be compounding if it is done by a pharmacist in response to a licensed practitioner’s prescription and produces a medication tailored to an individual patient’s special medical needs.
3. Is pharmacy compounding beneficial for patients?
It can be. Traditional pharmacy compounding enhances patient treatment with individually-tailored drugs when a physician deems that an FDA-approved drug may not be available or appropriate for that patient's care. Thus, traditional compounding is an important component of patient care.