Understand compounding
Made to order.
Ask why it is needed.
Compounding prepares medicine to order for a patient’s needs. Ask different questions about a medicine prepared this way.
FDA is short for Food and Drug Administration, the US drug review agency.
Approval and compounding follow different paths.
Approved finished drug
A reviewed product.
The FDA review applies to a specific finished drug product and its named uses.
Compounded drug
An individual need to explain.
As of September 2026, FDA says a medicine made to order may be an option when an approved drug is not available or cannot meet that patient’s medical need.
The finished compound does not gain approval.
As of September 2026, medicines made to order have no FDA approval; the agency does not check their quality, safety or benefit before sale.
FDA says poor compounding can put unwanted material into a medicine.
Poor compounding can also produce an excess or a shortage of the ingredient responsible for the drug’s effect.
Ask who makes the medicine.
As of September 2026, a pharmacy or doctor making medicine to order for one named patient generally needs that patient’s valid prescription.
Sterile means the medicine is free of living germs.
An outsourcing facility is a business registered with the FDA to make batches of sterile medicines.
As of September 2026, that business can make these batches without a separate prescription for each patient.
FDA registration does not mean the agency approves that business or the medicines it makes.
Ask for the reason, source and limits.
As of September 2026, Florida requires medicines made to order for people to follow the federal compounding rules that apply to them.