Ask before agreeing to a compounded medicine
What need does it meet for me?
FDA, the federal medicine review agency, says compounding may fit a patient whose medical need an approved product cannot meet, or when that product is unavailable.
Why is a ready-made option not suitable?
Ask the prescriber to explain the specific difference, rather than relying on a general claim of custom care.
Who will prepare it?
Request the actual compounder’s name. The company running the visit may not be the place making the medicine.
How does this medicine meet the rules?
Federal law, checked September 26, 2026, bars a pharmacy from regularly making copies of medicines already sold, or making them in excessive amounts.
A patient-specific change that the prescriber finds makes a significant difference can fall outside that copy rule.
Ask what change matters for you and where the prescriber has recorded that reason.
What FDA review does not cover
Compounded medicines lack FDA approval as of September 26, 2026.
FDA does not check their safety, effectiveness or quality before they are marketed.
Effectiveness means whether a treatment does what it is meant to do.
A maker saying it is registered with FDA does not mean its medicine has FDA approval.
A vitamin alone does not answer whether it is a copy
As of September 26, 2026, FDA says an injection with the same medicine ingredient and a similar strength can still count as a copy.
Adding a vitamin does not by itself change that answer when the injection is given the same way.
The change must make a significant difference for that patient, and the prescriber must record it.
Ask what the difference is for you and how the prescriber reached that answer.
Arizona rules also apply
As of October 6, 2026, medicine made to order in Arizona must be prepared at a place permitted by the state Pharmacy Board.
That is the state office that oversees pharmacies. The maker must also follow state and federal medicine-making rules.
Arizona applies different standards to pharmacies filling individual prescriptions and larger batch makers permitted as manufacturers.
Ask the maker which type it is. On the pharmacy-check page, use the state permit check and, for a registered batch maker, the FDA list.
A state permit does not itself authorize every ingredient or medicine.
Ask the prescriber and pharmacist to explain both the ingredient rules and the limits on copying a ready-made medicine.