Compounding
What “compounded” tells you.
It describes how a medicine is prepared. Ask why that preparation is needed for your care.
Made to order has a specific meaning
When a medicine is compounded, it is prepared for a patient’s need in place of a ready-made approved product.
- Compounding may help a patient who cannot use an approved product, such as someone who is allergic to a dye.
- As of September 26, 2026, compounded drugs were not approved by the Food and Drug Administration (FDA).
- The FDA does not review each compounded product for quality, benefit, or harm before it reaches patients.
Not every medicine may be made to order
A pharmacy still has to check whether the law allows each ingredient it uses. A pharmacy licence and your prescription alone do not give permission to use any ingredient.
- Federal limits still applied on September 26, 2026 to the raw ingredients used by a regular compounding pharmacy.
- Federal law restricts pharmacies from repeatedly making, or making large amounts of, drugs that count as copies of available approved medicines.
- For weight medicines, FDA generally counts a made-to-order drug as a copy when it has the same treatment ingredient, the same or similar strength, and is taken the same way as the available product.
- Your prescriber can decide that changing the medicine would make an important difference for you as an individual. That patient-specific change can qualify for an exception to the copy rule; a lower price alone cannot.
The weight-medicine shortage changed
A medicine on FDA’s national shortage list has different rules for making copies. An empty shelf at your local pharmacy does not add a medicine to FDA’s national shortage list.
- FDA’s shortage list did not include semaglutide injections (Ozempic or Wegovy) or tirzepatide (Mounjaro or Zepbound) as of September 26, 2026.
- A compounded product may still count as a copy under FDA’s policy after a vitamin is added.
- FDA’s stated position is that compounding cagrilintide and retatrutide is barred by federal law; this was checked September 26, 2026.
Ask why it is needed for you
Keep the discussion tied to the exact product and the need it is meant to meet.
- Why can’t an approved medicine meet this need?
- How will the medicine be changed for my needs, and why does that change matter?
- Which pharmacy will make it? Which legal rule allows it to use this ingredient?
- What information will come with it, and who will answer questions?