What compounding changes
With compounding, a licensed pharmacist (a medicine professional), a medical doctor or a registered business prepares a medicine to order.
Why this source matters
An approved finished product is supplied ready-made; this preparation is made for an order.
The September 26, 2026 check found that compounded drugs had no US Food and Drug Administration (FDA) approval.
FDA did not review their quality, effects or safety before they were sold.
Why this source matters
This limit applies even when a pharmacy is well run.
Why the individual reason matters
Under rules checked September 26, 2026, ordinary pharmacies cannot regularly make medicines that are essentially copies of available drugs.
There is an exception when a change makes an important difference for a particular patient.
The prescriber must find that the change matters to that patient and write down why.
Why this source matters
It is the prescriber who decides if the difference is significant for the individual patient.
For instance, a dye allergy may mean someone needs that dye left out of their medicine; someone who cannot swallow a tablet may need another form.
Why this source matters
These are examples of patient needs, not automatic permission to make a copy.
- Which need does the approved product fail to meet?
- What change is being made for me?
- Who prepares the medicine?