Compounding means making medicine to order

The US drug agency is called FDA, short for Food and Drug Administration.

Compounding means making medicine to order. A licensed pharmacist, doctor or registered medicine-making business can do this work. FDA guidance checked September 17, 2026.

Ask what is different about the custom medicine and why that change matters for the person being treated.

Custom does not mean approved

FDA does not check custom medicines for safety, quality or whether they work before they are sold. FDA guidance checked September 26, 2026.

FDA says medicine made to order may meet a health need that an approved medicine cannot meet. FDA guidance checked September 26, 2026.

Ask what need the custom product is meant to meet. The answer needs to be more precise than a preference for something different.

A copy faces limits

When pharmacies or doctors copy available medicines repeatedly or in unusually large amounts, federal limits apply. This is not a blanket ban on making medicine for one person. Federal rule checked September 26, 2026.

The prescriber is the licensed health professional who orders your medicine.

The copying rule allows a change for a named patient when the prescriber decides it makes an important difference for that patient. The difference is between the custom medicine and the available medicine. Federal rule checked September 26, 2026.

Ask for the reason in plain words and in the visit record. A lower price does not answer why this product can be offered.

Keep the pharmacy name with the plan

  • Who will prepare this medicine?
  • What need does this preparation meet?
  • Why does an approved product not meet that need?

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