Custom preparation has a specific purpose
The Food and Drug Administration (FDA) describes compounding as preparing a medicine for needs a finished product may not meet. FDA: why compounding exists
Custom medicines made through compounding have no FDA approval; their quality, safety or benefit receive no agency review before sale, as of September 26, 2026.
- What need does this custom version address?
- Could an approved product meet that need?
- Who would prepare it?
A permit is a separate check
To send medicine into Arizona, an out-of-state pharmacy needs pharmacy permits for Arizona and its home location, as of October 3, 2026. Arizona: pharmacy permit law
A permit is official permission for the pharmacy to operate or send medicine.
Pharmacies filling prescriptions for named patients and facilities making batches under different federal rules face separate Arizona compounding standards, as of October 6, 2026. Arizona: updated compounding rules
An outsourcing facility makes batches of sterile medicines, meaning medicines free of living germs.
- What is the pharmacy's full name?
- Which Arizona permit covers it?
- Where can I ask questions about the label?
Lower cost does not settle the copying rule
Federal law restricts routine pharmacy compounding of custom versions that are essentially the same as medicines already available to buy, as of September 26, 2026. FDA: limits on compounded copies
A change can make a product different under this rule if the prescriber finds it makes a significant difference for a specific patient.
A cheaper price is not the kind of difference this rule recognises.
Ask the prescriber to write down what is changed and why it matters for your health. This copying rule is one part of the checks for a custom medicine.
For semaglutide injections and for tirzepatide injections, the FDA's national shortage listing had ended as of September 26, 2026. FDA: national supply status
One pharmacy running out does not mean there is an FDA-listed national shortage, according to guidance checked September 26, 2026.
- What does the custom version change, and why do I need that change?
- Which rules allow this exact ingredient and custom product? Please show me the FDA explanation.