Understand / Made-to-order drugs
Made to order still needs an explanation.
Ask which of your needs the ready-made medicine cannot meet. Then ask who will make the medicine and which rules allow it.
Why a made-to-order drug may be discussed
Compounding prepares a medicine to suit a patient’s need instead of using a ready-made product.
FDA gives examples of a need such as a dye allergy or difficulty swallowing a tablet.
FDA does not approve compounded drugs. Before sale, FDA does not review these drugs for safety, quality or how well the treatment works. This rule was checked on September 26, 2026.
Some patients may need a medicine prepared to order. That need does not give the made-to-order medicine FDA approval.
What limits apply to copies?
US law limits making copies of ready-made medicines already sold on the market. Pharmacies cannot make those copies regularly or in very large amounts. This rule was checked on September 26, 2026.
For a pharmacy making a medicine for one patient, the prescriber must judge the change to be an important difference for that individual. That changed medicine falls outside the copy restriction.
Under this rule, saving money by itself is not an important difference for the patient.
Ask: “How has this medicine been changed, and what does that difference mean for my health?”
A national shortage is a different matter.
A shortage listing is a national FDA record; it is not the same as an empty shelf at a local pharmacy.
An exception to copy limits may apply when FDA lists the medicine in its national shortage record.
Semaglutide and tirzepatide were absent from FDA’s national shortage list when checked on September 26, 2026.
FDA says federal law does not allow making medicines to order with retatrutide or cagrilintide. This was checked on September 26, 2026.
Ask the pharmacy three questions: Is this ingredient allowed? What permits making this copy for me? If you say there is a shortage, is the medicine on FDA’s national list?
Ask for the reason, not just the label.
Notes are not sent. Copy what you want to keep before leaving this page.