The compounding chapter
What does “made to order” change?
In compounding, a doctor or pharmacist makes medicine for a patient rather than using a ready-made product.
The review
It changes what has been reviewed.
As of September 2026, compounded drugs have no approval from FDA, the Food and Drug Administration.
Before patients receive it, FDA does not check a compounded drug’s quality, safety, or how well it works.
Compounding may fill a need that approved products cannot, such as leaving out a dye a person is allergic to.
Ask what need the proposed change is meant to meet for you.
Source notes
FDA’s explanation of compoundingThe limits
There are limits on making copies.
As of September 2026, federal law sets limits on copying approved medicines already sold. A pharmacy or doctor may not make those copies routinely or in unusually large amounts.
FDA’s copy guidance compares the treatment ingredient, strength, and how the medicine is taken. The ingredient may be the same and the strength the same or similar. The medicine may be taken the same way, such as by injection. Those similarities can make it count as a copy.
For a named patient, a prescriber may decide that a change makes a meaningful difference to that patient’s care.
A lower price is not the kind of difference that qualifies.
Semaglutide and tirzepatide are ingredients in diabetes and weight-management medicines.
As of September 2026, neither is on FDA’s shortage list.
A local pharmacy’s stock problem is different from a listing for a national shortage.
As of September 2026, FDA’s guidance says adding a vitamin does not automatically avoid the copy rules.
Do not assume that ordering only a few refills makes a copy lawful.
This guide cannot give you a safe number of refills.
Ask the pharmacy what rule permits this medicine and what change your prescriber has ordered for your own care.
Source notes
FDA’s current copy-policy notesThe wording
A label or badge can leave a false impression.
As of September 2026, no approved generic semaglutide or tirzepatide is available to US patients.
An approved generic copies a brand medicine. A compounded product belongs to a different category.
“FDA registered” is not another way to say “FDA approved”, as of September 2026.
Ask whether this exact medicine has FDA approval or is made to order, rather than relying on a badge.