Evidence
Shortage dates and copy policy
FDA’s dated policy record explains the end of the shortage and the limits on copies.
Food and Drug Administration (FDA), US
Read FDA’s compounding policy recordField notes The product
Check what was made, and why.
Is compounded tirzepatide just a generic?
The shortage once mattered to the rules. Its end matters too.
Myth to check
A pharmacy-made version has passed the same checks as a generic.
Rethink that tirzepatide assumption
Compounding is the preparation of medicine to meet a particular need. A version of a brand drug with its own approval is called a generic. As of 26 September 2026, medicines made by compounding are not approved by FDA, the US medicine regulator.
Making to order is a different route
In compounding, a pharmacist or a doctor makes medicine for a specific need.
For compounded medicines, FDA, the regulator for US medicines, gives no approval and does not check quality, safety, or effectiveness before they are marketed.
That remains true as of 26 September 2026, including for preparations from well-run pharmacies.
The shortage route has ended for tirzepatide
FDA confirmed the tirzepatide injection shortage was over on 19 December 2024.
Ordinary compounding pharmacies had until 18 February 2025 to stop making tirzepatide copies under the shortage exception.
Larger medicine-making sites, called outsourcing facilities, had until 19 March 2025. The end of the shortage removed that reason for making copies.
As of 26 September 2026, tirzepatide was absent from FDA’s national shortage list.
If one pharmacy has none in stock, that alone does not justify putting the medicine on the national shortage list.
Routine copies face a restriction
The rules checked on 26 September 2026 bar pharmacies from routinely making copies of ready-made medicines that are available. Making large amounts of those copies is also barred.
A patient-specific change may be allowed when the prescriber determines that the change makes a significant difference to that patient.
For example, compounding might allow a medicine to be made without a dye that causes an allergy in a particular patient. This is a general example, not a claim about a tirzepatide product.
A lower price alone is not that kind of difference.
At the September 2026 check, FDA said it did not plan to act against a pharmacy filling no more than four copy prescriptions in a month. That is a choice about enforcement, not a rule making those copies legal.
Some medicine can still be made to order lawfully. Ask what need it meets for you and which rule allows it.
Ask for the patient-specific explanation
Ask why the approved product cannot meet your need, how the medicine would be changed, and the name of the pharmacy preparing it.
The pharmacy’s name lets you check its licence record.
Evidence behind this note
Evidence
What approval does not cover
FDA describes compounded drugs as outside its review before marketing.
Food and Drug Administration (FDA), US
Read FDA’s explanation of compounding