How do compounded prescriptions differ from FDA-approved medicines?

Compounding means preparing a medication for an individual patient based on a prescription. Compounded medications are prepared by a licensed pharmacy for one patient and are not FDA-approved. A physician may consider compounding when a patient's needs cannot be met by an available FDA-approved medicine.

For example, a patient may need a different dosage form or may need to avoid a particular ingredient. Whether compounding is suitable depends on the specific medication and the patient's medical needs. A licensed physician in your state makes that decision after reviewing your health information.

The FDA does not review compounded medications for safety, effectiveness, or quality before they are marketed. Compounding can also carry risks, including contamination or an incorrect amount of an ingredient. A prescription does not remove those risks.

Ask your physician why a compounded option is being considered and what FDA-approved options may be available. Ask the pharmacy about storage, the use-by date, and directions. Do not change your dose or share a prescription with another person.