Why and how medicine is made to order
Making medicine for one patient is work a pharmacist or doctor can do, as an alternative to a finished product made in advance.
FDA explains that compounding may fill a gap in a patient’s needs when approved products cannot, for example by avoiding a dye allergy.
- What need would this change address for me?
- Why does a ready-made product not meet that need?
- Which pharmacy would make the preparation?
What has the FDA checked?
Medicine review is the U.S. role of the agency named Food and Drug Administration, or FDA.
At that point—September 26, 2026—compounded medicines still had no approval from FDA.
Before these preparations are sold, FDA does not review whether they work well, are safe, or meet quality standards.
- Ask what written product information you will receive.
- Ask who will explain that information.
- Look up the pharmacy named as the maker.
What about copies of weight medicines?
In the September 26, 2026 check, neither semaglutide nor tirzepatide appeared on FDA’s national drug-shortage list.
Federal law checked September 26, 2026 limits routine compounding of copies of drugs already on the market.
The person prescribing must decide that a change makes a real difference for the particular patient. Saving money by itself cannot be the difference that qualifies.
For example, a patient with a dye allergy may need medicine made without that dye when an approved product cannot meet that need.
Copies normally subject to limits may be allowed during a national shortage; the limits return once FDA declares that shortage over.
- Ask what is being changed for your own medical need.
- Ask how the person prescribing records why that change matters.
- Ask whether the exact drug is on FDA’s current national shortage list and what that means for this offer.