What has not been reviewed
As of September 2026, compounded medicine has no FDA (Food and Drug Administration) approval; the agency does not check its quality, safety or effects before it is marketed. FDA explains compounded medicines
As of September 2026, the FDA describes compounding as a way to meet needs that an approved medicine has not met.
Ask the person writing the prescription to name that need. Then ask which pharmacy will make the proposed product and how to contact it.
Check the reason behind a copy
A cheaper copy has separate rules
As of September 2026, pharmacies and doctors making medicines to order for individual patients cannot routinely make close copies of factory-made medicines that are already available. The copy rule for patient-specific pharmacy care
As of September 2026, there can be an exception to this copy limit. The prescriber must judge the change to be medically important for the particular patient named in the prescription. Saving money alone is not enough.
For example, a made-to-order medicine might leave out a dye that a patient is allergic to, or use a liquid for someone unable to swallow a tablet.
Ask how the proposed change meets the copy rule in your case. Keep that explanation separate from the savings claim.
An old shortage does not settle the current answer
As of September 2026, the FDA reports that semaglutide and tirzepatide are absent from the national drug-shortage list. FDA’s supply and compounding update
As of September 2026, an out-of-stock medicine at one local pharmacy differs from a nationwide shortage recorded on the FDA’s list.
After those national shortages ended, the FDA set deadlines for pharmacies to stop copying the drugs under the shortage rules. By September 2026, those deadlines had passed.
Ask and note
Under which rule can this pharmacy prepare the exact medicine for me at present?
Ask what “registered” is being used to mean
FDA registration means a medicine-making site is entered in the agency’s records. A drug listing is a product record supplied to the agency. As of September 2026, neither record is approval or permission to sell the product. The registration and listing rule
A product made by compounding does not qualify as an approved generic of an approved medicine, as of September 2026. FDA on misleading compounding claims
Ask for the product’s exact status and the pharmacy’s licence details. Price, registration and approval answer different questions.