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What changes when a medicine is made to order?

U.S. care · Facts dated September 2026

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Made to meet a need

A compounded medicine is made to order. It may address a need that ready-made medicines cannot meet. The Food and Drug Administration (FDA), a U.S. agency, does not approve these medicines or check them before sale. [a]

Understand the word before comparing products.

Compounding means preparing medicine for a particular need. A pharmacist, doctor, or larger medicine-making site registered with the FDA may do this. [a]

As of September 2026, medicines prepared to order still lack FDA approval. The agency does not review their quality, how well they work, or their safety before sale. [a]

That remains true when a licensed pharmacy prepares it.

The FDA says preparing medicine to order may help a patient whose need an approved medicine cannot meet, or when that medicine is unavailable. [a]

The question underneath

“What need of mine cannot be met by the ready-made medicine?”

A copy has its own limits.

As of September 2026, federal law stops pharmacists and doctors from regularly making copies of ready-made medicines that are available to buy. A change needed by one patient can be an exception. [b]

The person writing the prescription must find that the change makes a difference that matters for that particular patient. Then the changed medicine is not treated as a copy under this rule. [b]

Paying less is not, by itself, a change needed by that patient.

Ask what the change is and why it matters in your own care. A broad promise about price does not answer that question.

The FDA’s shortage list is about supply across the country.

The FDA lists medicines in short supply across the country. An empty shelf at a single local pharmacy is not enough to put a medicine on that list. [c]

An outsourcing facility is a larger place that makes batches of medicine, often for clinics and hospitals. It registers with the FDA and makes sterile medicine, meaning medicine free of living germs. It does not have to be a pharmacy.

The FDA’s shortage list excludes both semaglutide and tirzepatide, as of September 2026. Neither is on the list of raw ingredients allowed for the larger medicine-making sites described here. [c]

These lists therefore do not allow those larger sites to make either medicine from raw ingredients. [c]

The earlier shortages had allowed copies to be made. That permission ended when the shortages ended. The exception for a change needed by a particular patient is a separate rule. [c]

Ask for an explanation

Under the FDA’s position checked in September 2026, a medicine with an added vitamin is not automatically different enough to escape the limits on copies. [c]

Some ingredients cannot legally be made to order.

As of September 2026, the FDA’s position is that federal law prohibits compounding medicines with retatrutide or cagrilintide. [d]

Neither ingredient has been established as safe and effective for treating any condition, according to the FDA. [d]

Bring the exact ingredient name to the discussion. “Peptide” alone leaves the main question unanswered.

Source notes

FDA · The role and review of compounding

The agency’s explanation of medicine made to order.

U.S. Code · Limits on copies

When a change that matters for one patient can be an exception to the limits on copies.

FDA · Current policy on weight-drug copies

Whether medicines are in short supply and why adding a vitamin does not automatically avoid the limits on copies.

FDA · Ingredients that cannot be made to order

The agency’s position on retatrutide and cagrilintide.

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