What does “compounded” mean?

The main difference is review

FDA (U.S. Food and Drug Administration) states that compounded medicines lack its approval, as of September 2026.

FDA does not review compounded medicines for quality, safety or how well they work before patients receive them.

FDA also recognises a role for compounding when no approved medicine meets a patient's medical need.

• Ask what medical need you have that an approved product could not meet.
• Ask who actually makes the preparation.
• Ask for the pharmacy name before comparing prices.

What changed when the shortage ended?

As of September 2026, FDA’s policy update says semaglutide injection and tirzepatide are absent from the national shortage list.

Being on FDA’s national shortage list allowed pharmacies to make copies under federal rules. One local pharmacy running out does not give that same permission.

Federal rules restrict regular pharmacies from routinely copying medicines already sold on the market, as of September 2026.

For a regular pharmacy, an exception can apply if the prescriber decides that changing the medicine makes a significant difference for one named patient. The prescriber must write down that change and why it matters for that patient.

Cost savings by themselves do not qualify for this exception.

• FDA's September 2026 position is that a medicine may still count as a copy under these rules even with an added vitamin. This is a legal rule about making copies, not a laboratory test.
• Ask: What changed in the ingredients, strength or way this medicine is given? Why does that change meet a medical need for me?
• Ask the pharmacist which rules allow this exact medicine to be made for you.

A larger batch maker follows different rules

Some large facilities make batches for clinics and hospitals; these are called outsourcing facilities. FDA separately considers whether there is a medical need to let them make medicines from raw ingredients. As of September 2026, it does not count a cheaper price as a medical need.

FDA proposed keeping semaglutide, tirzepatide and liraglutide off the allowed raw-ingredient list for these facilities. As of September 2026, that was a proposal, not a final decision.

Ask whether your medicine comes from a regular pharmacy or one of these batch-making facilities, and why its rules allow this preparation.

Words that do not settle the question

Registration means the maker has submitted its details to FDA to be listed. As of September 2026, FDA says this does not mean it has approved the medicine or the place that makes it.

• If a seller says “FDA registered”, ask: Is this exact medicine FDA-approved, or is it made to order?
• Even at a low price, ask who treats you and which pharmacy makes the medicine.
• Ask why the medicine offered meets your medical need and the rules for making it.