What does compounded mean?

What is being made?

Compounding is preparing a medicine by mixing or altering ingredients, rather than providing a finished factory-made medicine.

FDA is the federal medicine agency, short for Food and Drug Administration.

FDA describes needs such as avoiding a dye that causes an allergy or making an alternative for someone unable to swallow a tablet.

Ask the person writing your prescription to name the medical need that a ready-made medicine cannot meet.

What review is missing?

Compounded medicines do not have FDA approval as of September 2026.

Before marketing, FDA does not review each compounded product for benefit, harm or quality.

That applies even when a pharmacy is well run.

As of September 2026, a larger business making batches of medicine can choose to register with FDA and appear on its list.

An entry on that list gives no FDA approval to either the business or the medicines it makes.

Registered facilities must follow factory quality rules, and FDA inspects them on a schedule based on risk.

• What change is being made for me?
• Why does that change matter medically?
• Who prepares the medicine?
• What information comes with it?

A lower price does not answer the copy rule

As of September 2026, federal law limits pharmacists and doctors making copies of medicines already sold. It limits making copies repeatedly or in excessive amounts.

A product may count as a copy when its ingredient, amount of medicine and way of taking it are the same or very similar.

The person writing your prescription can identify a change that makes a significant medical difference for you personally; a lower price alone does not qualify.

An FDA-listed national shortage can allow a medicine to be made under an exception to the limits on copies.

FDA’s shortage list records shortages across the country, rather than one pharmacy running out of stock.

Larger facilities making batches have a different federal rule on copies. They also face limits on raw ingredients; an FDA-listed shortage is one route that can allow their use.

Ask which type of business is making your medicine and which rule allows it. For weight medicines, ask whether FDA currently lists a national shortage and what personal medical change is documented.