Understand
What does pharmacy-made medicine mean?
The usual word is ‘compounded’. Get the name of the finished medicine and the reason for making it this way.
What is compounding?
In compounding, the patient receives medicine prepared for their needs by a pharmacist or doctor, in place of an approved finished product supplied by its maker.
As of September 17, 2026.
FDA · Preparing a medicine for a patientAccording to the Food and Drug Administration (FDA), compounding can sometimes address needs left unmet by an approved medicine. A patient allergic to one of its dyes is an example.
As of September 26, 2026.
FDA · When compounding may helpIs it reviewed like an approved medicine?
No compounded finished medicine is FDA-approved, even when a well-run pharmacy makes it.
As of September 26, 2026.
FDA · What the agency does not reviewBefore sale, FDA does not verify that finished medicine’s quality, safety, or effectiveness, meaning how well it works.
As of September 26, 2026.
FDA · The review gapCan any ingredient be used?
No. Federal compounding rules restrict ingredients and also limit making copies of readily available medicines.
As of September 26, 2026.
FDA · Ingredient restrictionsThe rules on copies have an exception for a change that makes a significant difference for one named patient. The clinician who writes the prescription must decide that the change matters for that patient.
As of September 26, 2026.
FDA · Changes for one patientFor example, ask whether the change removes a dye you are allergic to. That is a question about your needs; it does not by itself show that all the legal rules are met.
As of September 26, 2026.
FDA · A reason for making a different versionFind out which of your needs the approved product leaves unmet. Ask how the suggested change would meet that need.
Does being out of stock permit copies?
A local stock problem does not establish a national shortage on FDA’s list.
As of September 26, 2026.
FDA · What a national shortage meansOn September 26, 2026, that national shortage list included neither semaglutide nor tirzepatide injections.
As of September 26, 2026.
FDA · The shortage-dependent copy rulesDoes ‘FDA registered’ settle it?
Registration of a medicine-making facility does not approve its products or establish that they can lawfully be marketed.
As of September 26, 2026.
Federal rules · Registration and approvalGet the pharmacy’s full name. Then check the pharmacy and the proposed medicine as separate questions.