Made to order does not mean approved
FDA, the US drug agency named Food and Drug Administration, says custom medicines can meet needs that an approved product cannot. [a]
Compounded medicines still lack FDA approval as of September 26, 2026. FDA does not review their quality, safety or effect before sale. [a]
This applies even when a pharmacy has a licence. Ask what need the proposed change meets for you. [a]
A copy has extra limits
For pharmacies and doctors, making copies of ready-made medicines is limited by federal law as of September 26, 2026. The rule covers making them regularly or in large amounts. [b]
For a change made for one named patient, the person prescribing must decide that it makes an important medical difference for that patient. Cost savings alone do not meet that test. [b]
A person allergic to a dye may, for instance, need a medicine made without it. Ask what medical need your proposed change meets. [a]
Ask what is changed, why it matters medically, and how the prescriber records that reason.
An old shortage is not a current exception
Neither semaglutide nor tirzepatide injections remain on FDA’s national shortage list as of September 26, 2026. [c]
A pharmacy being out of stock locally does not put a medicine back on that national list. [c]
A shot made to order can still count as a copy when a vitamin is added. Adding the vitamin does not, by itself, make the copy legal. [c]
Retatrutide and cagrilintide are ingredient names you may see in offers for medicines made to order. They are not ingredients in FDA-approved drugs. [d]
As of September 26, 2026, FDA says retatrutide and cagrilintide cannot be used in medicines made to order under federal law. Neither ingredient has been shown to be safe and effective for any condition. [d]
Arizona standards are another check
Arizona sets different rules for pharmacies filling patient prescriptions and for larger drug-making sites, as of October 6, 2026. [e]
Some larger sites listed with FDA make batches of sterile medicines. They are called outsourcing facilities. Sterile means free of living germs. [f]
The state rule does not allow every ingredient or medicine. A medicine still has to meet federal law even when the maker has an Arizona permit. [e]
Ask the pharmacist preparing the medicine: “Is this exact ingredient and recipe allowed under federal law? What rule permits it, and why is it needed for me?”
Ask the person prescribing to explain the medical reason for any change. If the answers are unclear, ask the Arizona Pharmacy Board how to check the rule.