The compounding questions
Made to order needs a reason.
Ask what need the preparation meets, who makes it, and which rules apply to the actual product.
Made to order means a different process
Rather than supply a ready-made product, a doctor or pharmacist can prepare the medicine. That process is called compounding.
FDA gives a dye allergy as an example of a patient need that can call for compounding when approved medicines cannot meet it.
A compounded preparation lacks FDA approval as of September 2026; FDA has not reviewed its quality, safety, or benefit before marketing.
Ask which kind of preparation is involved
One kind is a pharmacy making a medicine for a particular person. As of September 2026, US law allows this when it has a valid prescription naming that person and meets the other legal conditions.
Another kind is a facility producing batches of medicines that are sterile, meaning they contain no living germs. It is called an outsourcing facility and often supplies clinics and hospitals.
As of September 2026, an outsourcing facility can register with FDA without being a licensed pharmacy. Ask for its FDA registration record as well as any pharmacy licence it holds.
As of September 2026, these facilities follow federal manufacturing rules and receive FDA inspections on a schedule based on potential problems.
That registration still does not make the compounded product FDA-approved, as of September 2026.
Explain the need for a changed medicine
A lower price does not explain the medical need
Federal law restricts making copies of commercially available medicines through regular compounding or compounding on a large scale, as of September 2026.
The person prescribing a made-to-order medicine can identify a change in it that makes an important difference to that patient’s care.
For example, ask whether removing a dye you are allergic to is the reason for making it to order.
A lower price alone does not explain a medical need for that change.
As of September 2026, injections of semaglutide and tirzepatide have come off FDA’s national drug-shortage list.
One local pharmacy running out does not, by itself, establish a national shortage listed by FDA.
An added vitamin does not answer the question either
In September 2026, FDA’s policy says semaglutide with an added vitamin may still count as a copy of a ready-made medicine. It compares the amount of semaglutide and how the medicines are taken. A vitamin may leave it a copy if the amounts are similar and both are injections, for example.
A name for a mixture of ingredients does not explain why you need that mixture. Ask what the change in the medicine does for your care.
Put the pharmacy name on the page
Ask for the pharmacy’s actual name and the exact ingredient list. Then check the licence record.
FDA notes that people receiving compounded drugs through online services may not know who made the product.
Check the pharmacy record