If this is where you are…
If a treatment is described as custom-made, ask what is being changed and why it matters for you. “Custom” does not finish the explanation.
Why a medicine might be made to order
Compounding is a pharmacist or doctor preparing a medicine for a patient’s needs instead of providing a ready-made finished drug.[a]
The Food and Drug Administration (FDA) describes uses such as leaving out a dye a patient cannot tolerate or changing a hard-to-swallow tablet.[a]
Ask which need the ready-made product cannot meet in your case.
What approval does not cover
As of September 2026, the FDA had not approved compounded medicines.[a]
Before sale, the FDA does not check how well these preparations work, their quality, or their safety.[a]
An outsourcing facility is a place that makes batches of made-to-order medicine. The medicine it makes is sterile: it contains no living germs.[b][c]
State pharmacy boards are mainly responsible for checking ordinary pharmacies. The FDA is mainly responsible for checking outsourcing facilities registered with it.[a]
Ask what sort of place would make it. A place’s FDA registration gave no approval to its medicines, as of September 2026.[b]
Check who actually supplies it
Before mailing prescription medicine into Colorado, an out-of-state pharmacy must register with Colorado, as of September 2026.[d]
Out-of-state outsourcing facilities also need Colorado registration before sending compounded prescription medicine here, as of September 2026.[d]
- Which pharmacy or facility makes this medicine?
- Why does the ready-made approved medicine not meet my needs?
- Which rule allows you to use this ingredient in a made-to-order medicine?
- Who answers a question about the label?