Keep the words apart
- Active ingredient
- Active ingredient names the substance doing the medicine’s work.
- Compounding
- Compounding makes a patient’s medicine by preparing or altering it in a pharmacy or a doctor’s practice.
- Product approval
- Before approval, FDA (Food and Drug Administration) reviews the evidence for that exact medicine. It must work and be safe enough for the health problem named in the approval, as of 26 September 2026.
For example, FDA-approved products as of 26 September 2026 include tirzepatide (Mounjaro, Zepbound), alongside semaglutide (Ozempic, Wegovy).
A compounded product has a different status
A compounded medicine has no FDA approval as of 26 September 2026. FDA does not check its safety, how well it is made or whether it works before it goes on sale.
If an approved medicine does not meet a patient’s needs, there may be a reason to consider compounding, as of 26 September 2026.
Ask: “Why would the approved, ready-made medicine not meet my need? What would the pharmacy change for me? Which rule allows that change?”
For pharmacies making medicines for named patients, price alone cannot justify routinely copying a medicine already sold ready-made. The person writing the prescription must judge that a change makes a significant difference to that patient. This rule was checked on 26 September 2026.