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A different kind of medicine
# Made for a need. Bound by rules.
Compounding prepares a medicine by making or mixing it for the needs of a patient. Ask why an approved medicine would not meet your need and who would make the proposed medicine.
As of September 2026.
A few words, made clear
Medicine review is part of the federal Food and Drug Administration's work; FDA is its short name. Essentially a copy is the law's term for a made-to-order version of an available medicine. The rules limit when a compounder may make it.
Get clear
## A real role does not mean FDA review
As of September 2026.
FDA says a made-to-order medicine may have a role if an approved drug is unavailable or cannot address a patient's medical need.
FDA does not approve made-to-order drugs. It does not check their safety, results or quality before sale.
Ask what the change is meant to solve for you. Keep that answer alongside the proposed medicine name.
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Source text
FDA on compounding and review
Look closer
## The kind of compounder matters
As of September 2026.
Under federal rules called 503A, a regular pharmacy can make a medicine for a patient named on a prescription. The number names that part of the law.
It needs a valid order for that patient and must meet the other rules.
Sterile medicine is free of living germs. A larger place making batches of sterile medicine can choose FDA registration under rules called 503B. Registration means joining FDA's list of these places. FDA calls this an outsourcing facility; it actually makes the medicine, often for clinics or hospitals.
These batch-making places must meet federal factory rules, and FDA inspects them.
Ask whether a pharmacy is making the medicine for you by name or a larger place is making it in batches. Ask who actually makes it and how their work is checked.
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Source text
FDA explanation of who can make medicine to order
FDA information on places making medicine in batches
Keep asking
## Copying an available drug is limited
As of September 2026.
Federal law places limits on regularly making drugs, or making them on a large scale, if they are essentially copies of available approved medicines.
For a pharmacy filling a prescription in your name, an exception may apply if your prescriber finds the change makes a significant difference for you. Paying less, by itself, does not qualify.
Semaglutide is an ingredient in diabetes and weight-loss medicines. Adding a vitamin to it does not by itself remove the copy limit.
Ask what the change will do for your medical need that the available medicine cannot. Ask the prescriber to explain that difference in your record.
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Source text
FDA clarification on copies and added vitamins
Carry it forward
## The shortage permission for these copies has ended
As of September 2026.
Tirzepatide is another ingredient used in diabetes and weight-loss shots. As of September 2026, neither it nor semaglutide injections were on FDA's national shortage list.
An FDA listing for a national shortage allows compounding that the usual copy limits would prevent. A stock gap at your local pharmacy is different from a place on FDA's national shortage list.
Ask why you need a made-to-order medicine now and what keeps a ready-made product from meeting that need. Ask the prescriber to explain and record the reason.
Read the source note
Source text
FDA updates on shortage-related compounding
Return to the exact medicine
Your next page
## Check the pharmacy making it
Find the record behind the compounding offer.
## Check the pharmacy making it
This notebook helps you think through care choices; it does not provide clinic care or sell medicines.
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