Source record
Custom drugs and FDA review
The FDA describes compounding as a possible response to a patient need, while distinguishing it from drug approval.
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What is a custom-made medicine?
Making medicine to order is called compounding. Ask what is being changed, who makes it and why the change matters for your care.
Who orders and makes the medicine?
- Person ordering medicine
- Place making medicine
- Exact medicine name
It means making medicine to order.
A pharmacist, doctor or registered custom-drug facility prepares medicine to order through a process called compounding.
It can serve a need that a finished approved product cannot meet, such as an allergy to a dye.
As of September 26, 2026, custom medicines lack FDA approval.
The FDA does not check each custom medicine’s quality, how well it works or its safety before it is sold.
Who makes the custom medicine?
Federal law allows a pharmacy or licensed doctor to prepare custom medicine when a valid prescription names the patient, as of September 26, 2026.
Other conditions in that law must also be met.
Another kind of drug maker is called an outsourcing facility. It registers with the FDA to make sterile medicines, which are free from living germs.
It need not be a licensed pharmacy and may make medicine without a prescription naming an individual patient.
Those facilities must meet federal rules for making drugs and are inspected by the FDA.
Ask whether a pharmacy or an outsourcing facility will make your medicine. Ask for that place’s full name, rather than the name printed across a care website.
A custom copy needs its own explanation.
As of September 26, 2026, federal rules limit routine compounding of medicines that are essentially copies of available approved drugs.
When a pharmacy or doctor prepares medicine for an identified patient, the prescriber may find that a change matters enough to make an important difference for that person.
That finding can keep the medicine from counting as a copy under this rule. It does not remove the other legal requirements.
Saving money does not qualify as the important difference under this rule.
Ask what is being changed and why the approved medicine cannot meet your health need. Ask for the health reason for the change as well as the price.
The record behind the answer.
Arizona record
Arizona’s updated compounding rule
As of October 6, 2026, Arizona has different rules for pharmacies making medicine for named patients and outsourcing facilities with state drug-maker permits.
Ask which kind of place will make your medicine and which state permit it holds.
A state compounding permit does not authorize every ingredient or product.
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