A prescription is an order, not product approval
As of September 2026, U.S. prescription medicines had to be supplied on an order from a practitioner licensed to prescribe them.
FDA—the Food and Drug Administration—gives no approval to compounded medicines, including those a clinician prescribes.
Compounded means made or changed by a pharmacy or doctor for a patient’s need.
Ask the clinician to explain the product as well as the reason for it.
A made-to-order medicine needs a made-to-order reason
FDA’s September 2026 position allowed compounding as an option if an approved medicine was unavailable to purchase or could not meet a patient’s need.
Ask what need the approved option cannot meet in your case.
Then ask what the proposed change is meant to solve.
As of September 2026, pharmacies and doctors could not regularly make copies of medicines already available to buy, or make them in large amounts.
For one named patient’s medicine, a change can be outside the copy rule if the prescriber judges it to make a meaningful difference for that patient.
Have the clinician name the change and explain its health significance for you.
An old shortage story is not a current answer
FDA’s September 2026 national shortage list included neither tirzepatide nor the injection form of semaglutide.
A local pharmacy running out of stock is different from a national FDA shortage listing.
FDA’s September 2026 copy rule looks for the same active ingredient and way of taking the medicine. Its strength can match or be close enough to use in place of the existing medicine.
A medicine’s strength describes the amount of its active ingredient.
Adding a vitamin to that medicine does not by itself avoid the copy rule, as of September 2026.
Ask how the specific product meets today’s rules. A broad answer about a past shortage leaves that question open.
- Which ingredient produces the medicine’s effect—the active ingredient?
- Would I receive an approved product, or would it be prepared through compounding?
- What alternatives did you consider?
- Who will explain the label and answer questions later?
Open the rules behind the prescription questions
The shortage position above is a dated answer. Ask the clinician to check the current position for your product.