Pharmacy-made does not mean FDA-approved.

What has the FDA reviewed?

As of September 2026, compounded preparations did not have FDA approval. FDA does not review their quality, effectiveness or safety before they are marketed.

A patient may need something an approved medicine cannot provide. FDA, the Food and Drug Administration, says compounding can fill that medical need.

For this patient, what need calls for that particular preparation? A pharmacy licence and a product approval are different checks.

Why does national supply status matter?

Neither tirzepatide nor semaglutide injection had a national shortage listing with FDA as of September 2026.

The national listing and a shortage of stock at your own pharmacy are different things.

Federal rules limit how often, and in what amounts, pharmacies or doctors can make copies of an approved medicine that is available to buy.

A change to the medicine may qualify for an exception when a doctor or pharmacy prepares it for an identified patient. The prescriber has to judge that the altered preparation offers an important difference for the individual patient over the approved product available to buy. Being cheaper, by itself, does not satisfy that test.

That is not blanket permission for all pharmacy-made versions. Ask the prescriber to explain the basis for the exact preparation.

Which claims need a closer look?

FDA guidance checked in September 2026 rejects two descriptions of compounded drugs: calling them approved generics, and claiming proof that their results match an approved product’s results.

FDA also says semaglutide sodium and semaglutide acetate are different active ingredients; it knows of no lawful basis for using them in compounding.

Ask for the ingredient’s exact name, the pharmacy’s name and the reason an approved product cannot meet the need.