“Compounded” means made to order.

A custom preparation needs a clear reason.

Compounding is making medicine for a patient’s particular needs, with a pharmacist or doctor preparing it.

The Food and Drug Administration (FDA) describes needs such as an allergy to a dye or difficulty swallowing a tablet.

Ask what is being changed and why the ready-made product would not meet your needs.

Check the pharmacy’s licence and the medicine’s approval separately.

As of September 26, 2026, compounded drugs have no FDA approval. FDA does not review their quality, safety or ability to work before sale.

As of that date, a business could choose to register with FDA as a place making batches of custom medicine. Registration did not give FDA approval to either the business or its medicines.

“FDA registered” describes the business’s registration, not a passed test of its medicines. It does not prove that a medicine is approved.

State pharmacy boards are the main day-to-day watchdogs for ordinary pharmacies. FDA has the main oversight of registered businesses making batches of custom medicine.

Ask who makes the medicine and which record supports the pharmacy’s licence.

A cheaper copy is not an automatic exception.

As of September 26, 2026, federal rules stop ordinary pharmacies from routinely making copies, or making unusually large amounts of copies, of approved medicines already sold.

Businesses registered with FDA to make batches of custom medicine face separate rules against copying approved medicines.

The copy rules ask whether the medicine has the same active drug, the same or a similar strength, and the same way of taking it.

For medicine a pharmacy prepares for a named patient, the prescriber can decide that a change makes a significant difference to that person. That means the change matters for that person’s medical needs.

A dye allergy is an example of a medical need for a changed medicine. Ask your prescriber to explain how the change addresses your own needs.

A price saving alone does not meet that test.

Ask which rule allows this exact medicine to be made for you. A lower price does not prove that it meets the rules or has FDA approval.

Old shortage explanations need a date.

As of September 26, 2026, FDA’s national shortage list no longer included either semaglutide (Wegovy and Ozempic) or tirzepatide (Zepbound and Mounjaro).

FDA had allowed extra time for pharmacies and larger medicine-making businesses to stop making copies after the shortages ended. Those temporary periods had ended by September 26, 2026.

A local pharmacy running out of stock does not, on its own, put the medicine on that national list.

A copy with an added vitamin does not automatically meet the rules for being different enough. FDA says semaglutide with vitamin B12 can still count as a copy of the same injection at a similar strength.

For your prescription, ask why the vitamin is needed and whether the person writing it has recorded a change that matters for your medical needs.

These limits still allow medicines made to meet a patient’s medical need when the compounding rules are met. For a changed copy, the person writing the prescription must identify the important difference for that patient.

A past shortage, a vitamin added to the mixture or a lower price alone does not answer that question.