What if the offer is compounded?

In compounding, a pharmacist, doctor or registered facility prepares medicine for an order.

For medicines in general, one use is omitting a dye that would trigger a patient’s allergy.

Medicines prepared through compounding lack Food and Drug Administration (FDA) approval.

Before a compounded medicine is marketed, the FDA does not review its quality or safety, or assess how well it works.

A national medicine shortage can allow pharmacies to make copies that the usual rules would restrict.

Once that shortage ends, the usual limits on making copies apply again.

Tirzepatide did not appear on the FDA’s national medicine shortage list on September 26, 2026.

After the shortage ended, the FDA gave medicine makers time to stop relying on the shortage rules for making copies.

This time ended on February 18, 2025, for regular compounding pharmacies and March 19, 2025, for outsourcing facilities.

An outsourcing facility makes medicines in batches for clinics or hospitals, with no prescription for a named patient required.

These medicines are sterile, meaning free of living germs.

Federal law limits routinely making medicines that are nearly the same as finished products already available.

An exception can apply when the person prescribing decides that a change to the medicine makes a significant difference for a particular patient.

The prescriber must record what is being changed and explain why the difference matters to that particular patient.

That exception applies to the named patient; it does not give general permission to make copies.

Paying less for the medicine is not enough to meet this exception.

Ask: “What will differ from the approved medicine, and why does that difference matter for me?”