The care guidebookOpen the page directory

Compounding notes

Ask why a pharmacy-made version is being offered

A compounded medicine is mixed or prepared separately by a pharmacy, doctor or registered facility. Ask why this is being offered for your health problem.

The source notes used here were recorded on or before September 26, 2026. Later changes may be missing.

What the word on the label means

A doctor, pharmacist or registered facility makes the medicine separately, rather than handing over a ready-made factory product.

A medicine prepared this way has no FDA approval. FDA does not review this medicine’s safety, how well it works or its quality before sale.

An unmet medical need is one reason FDA gives for considering it when approved medicines cannot fill that need.

Page notes[a][b]

The national shortage has ended

FDA’s February 21, 2025 decision marked the national semaglutide injection shortage as resolved.

A check on September 26, 2026 found semaglutide injections absent from the national shortage list.

A local stock problem does not itself put a drug on that national list.

The law limits pharmacies and doctors who make medicines separately: they cannot routinely make copies of medicines already on sale, or make those copies in excessive amounts.

Page notes[c][d]

Ask for the patient-specific reason

The law checked on September 26, 2026 makes an exception when the prescriber finds that a change to the medicine matters for one named patient. The legal words are “significant difference”: the change must matter for that person’s care.

Paying less, on its own, is not a medical reason for this exception.

One FDA example is leaving out a dye because the patient has an allergy to it.

A vitamin added to the mixture does not automatically make the copy lawful. FDA says a vitamin blend may still count as a copy under the law.

Ask what change matters for your medical need and where that reason is documented. Request the ingredient and pharmacy details too.

Page notes[e][f]

Read the ingredient wording closely

“Semaglutide sodium” is one salt version; “semaglutide acetate” is another. A salt here means a chemically different form of the medicine’s working ingredient. In FDA’s record dated September 26, 2026, neither uses the same active ingredient as the approved medicines.

The active ingredient is the part that does the medicine’s work. FDA says it knows of no lawful basis for making compounded medicine with these salt versions.

Ask the pharmacist to explain any ingredient wording you do not recognize.

Page notes[g]

Notes for this page