Made-to-order drugs
What changes with a made-to-order medicine?
Ask why a pharmacy or doctor would make a medicine to order for you instead of using a finished product.
Federal rules as of September 26, 2026; Minnesota rules as of October 1, 2026.
Made to order does not mean checked by the FDA
Compounding makes a medicine to fill an order.
Minnesota Care Briefings uses FDA as shorthand for the federal drug agency called Food and Drug Administration.
Patients receive compounded drugs without an FDA review beforehand of their safety, quality or effectiveness.
A compounded drug is not FDA-approved, including when it comes from a well-run pharmacy.
Ask what need an approved finished product would leave unmet. Ask what the proposed change is meant to do for you.
Check the maker and the compounding rules
Under section 503A of federal law, a pharmacy prepares a medicine for a specific person whose prescription names them.
It must also meet the rest of that law; “503A” alone does not tell you whether your medicine is allowed.
Section 503B covers a larger medicine-making site, called an outsourcing facility, that makes batches for places such as clinics and hospitals.
It can supply those places without a prescription naming each patient.
Federal law still requires a valid prescription when a prescription medicine is dispensed, or supplied, to you.
These numbers name the sections of federal law that set the rules for each kind of maker.
Sterile means free of living germs.
These batch-making sites prepare sterile medicines and register with the FDA; they do not have to be licensed pharmacies.
The batch-making sites follow federal factory-quality rules and FDA inspections; ordinary compounding pharmacies still have state and preparation standards to meet.
Copying an available medicine has limits
For an available drug, Minnesota allows a made-to-order copy only if the prescriber identifies a change that makes a significant difference to that patient.
Under federal rules, saving money alone is not a significant difference for the patient.
Ask: “What change in the medicine matters for my care, beyond a lower price?” The law’s section number does not answer that question.
An old shortage does not settle today’s question
A national shortage can open a route for making copies under federal compounding rules.
The check dated September 26, 2026 found neither semaglutide injections nor tirzepatide on the FDA shortage list.
One pharmacy running out of a drug is a separate issue from a national shortage listing.
Ask what current rule the prescription relies on. “It was allowed during the shortage” leaves the present question open.