Made to order needs a reason.

FDA is an agency responsible for medicine reviews. The letters stand for Food and Drug Administration.

FDA says a made-to-order medicine may address a patient’s need when an approved medicine cannot.

For example, a patient may need a medicine without a dye they are allergic to, or a liquid because they cannot swallow a tablet.

Read the parts about patient needs and the difference in review.

As of September 2026, federal law allowed medicines to be made to order through two routes, each with its own conditions. One route permits a licensed pharmacy or doctor to prepare medicine on a valid prescription for an identified patient. The other covers a facility that makes batches, often for clinics. It is registered with FDA, meaning its details are recorded with the agency.

For an ordinary pharmacy using a raw ingredient, federal law sets three possible checks. If an official quality standard exists, the ingredient must meet it. Without such a standard, the ingredient must be contained in an approved medicine. When both of those options are absent, the federal list of extra ingredients permitted for compounding must include it.

Ask the pharmacy which ingredient check it meets and to show you the supporting record.

As of September 2026, federal law restricted copies of ready-made medicines already available. Ordinary pharmacies and doctors could not make these regularly or in large amounts. A copy here means a medicine that is much the same as the ready-made one.

The health professional who writes your prescription is the prescriber.

The rule for ordinary pharmacies makes an exception for a change that matters for one named patient. The prescriber must decide that it makes a significant difference compared with the ready-made medicine. A lower price does not count as that difference.

Ask the prescriber to write down the change and why it matters for you. That answer still needs to fit the other rules, including the ingredient checks.

As of September 2026, shots containing semaglutide or tirzepatide were not on FDA’s national shortage list. These medicines are used for type 2 diabetes or weight loss, under brands including Ozempic, Wegovy, Mounjaro, and Zepbound.

A local pharmacy’s empty shelf does not establish an FDA-listed shortage across the country.

• What change do I need, and why?
• Which rule allows this pharmacy to use this ingredient and make this medicine?
• Which ready-made medicines were considered first?

FDA points out that an online-service patient may be unaware of who prepared the medicine.

Ask for that name before paying. Keep it beside the prescriber’s name in your notes.