Check the product
Understand made-to-order medicine
Ask what calls for a medicine prepared to order.
For a preparation made to order, ask why a drug maker’s approved medicine cannot meet your need. Get that explanation before comparing prices.
The care check
NAME.CHECK.Bring the open question.What compounding means
A compounded drug is made to order by a pharmacist, doctor or another medicine maker.
FDA describes a possible role when an approved drug cannot meet a patient’s need, such as an allergy to a dye.
As of September 2026, compounded drugs had no FDA approval; FDA had not checked each product’s quality, effects or safety before it was offered to patients.
Ask who makes the medicine and who checks them
Under federal law, 503A covers a pharmacy or doctor preparing medicine for an individually named patient. As of September 2026, a valid prescription and the law’s other conditions were needed.
A prescription alone is not enough: the maker must also meet the limits on copying medicines described below.
503B covers a maker that lists itself with FDA to prepare batches of medicine for places such as clinics and hospitals. The law calls this maker an outsourcing facility. As of September 2026, it could prepare batches without prescriptions naming each patient.
That describes how batches are made. You still need a valid prescription to receive a prescription medicine.
For an ordinary pharmacy making medicine to order, check with its state board of pharmacy, the main organisation watching its day-to-day work. For a batch maker listed under 503B, FDA is the main organisation watching its work.
Ask why the change matters for you
As of September 2026, federal law limited routinely making a medicine that was essentially the same as one already on sale. For a named patient, the person writing the prescription could record why a change to the medicine made an important difference.
Under this rule, a price reduction by itself was not an important difference for the patient.
One possible medical need is an allergy to a dye in the approved medicine. Ask what change is needed for you and have the person writing the prescription explain it.
- What need does this change address for me?
- Who prepares it, and where can I check that name?
- What written product information comes with it?
Read the record
- Read FDA’s compounding answers
Read about why someone may need a medicine made to order, who checks the maker and why these medicines have no FDA approval.