Tirzepatide

In short. Tirzepatide is a GLP-1 receptor agonist drug. FDA has approved drug products that contain it, and its shortage is over; a compounded tirzepatide preparation is not FDA-approved. In TrueRoute it is ordered as a patient prescription that the prescriber signs.

What it is

FDA describes semaglutide and tirzepatide as glucagon-like peptide-1 (GLP-1) receptor agonist drugs.

FDA status

On December 19, 2024, FDA determined that the tirzepatide injection shortage is resolved. When a shortage is resolved, FDA generally considers the drug commercially available, and its shortage-based enforcement discretion for 503A compounders has ended.

Because FDA has approved drug products that contain tirzepatide, FDA’s guidance on compounded drugs that are essentially copies applies: a 503A pharmacy may not compound, regularly or in inordinate amounts, a drug that is essentially a copy of a commercially available drug product. FDA ties the difference to a change that the prescriber determines makes a significant difference for the patient, documented on the prescription.

Compounded medications are not FDA-approved, and FDA does not review them for safety, effectiveness or quality.

How it is ordered in TrueRoute

Tirzepatide is ordered as a patient prescription. The prescriber names the patient, chooses the product from your catalogue at your account’s price, reviews the order total and signs. Before anything is charged, TrueRoute checks what it can check, such as the prescriber’s licence in the patient’s state as attested and whether the product can be sent there, and selects the route under its written routing policy. Orders are filled by licensed pharmacies in our network.

The forms and strengths your account can order, with their prices for your ship-to state, are shown in your catalogue once your account is set up. This page lists none, because what is carried changes.

What the prescriber decides

The prescription is the prescriber’s. They decide whether tirzepatide is appropriate for the patient and set the product, quantity and directions. TrueRoute is software: it does not recommend a medication, a dose or a product, it does not dispense, and it does not practice medicine.

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Questions

Sources

1. FDA, “FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize” (content current as of April 1, 2026)
2. FDA, “FDA’s concerns with unapproved GLP-1 drugs used for weight loss” (content current as of October 1, 2026)
3. FDA, “Compounded drug products that are essentially copies of a commercially available drug product under section 503A”, final guidance (January 2018)
4. FDA, “Compounding and the FDA: questions and answers” (content current as of September 16, 2025)

Rules change. Confirm what applies to your clinic with your state board of pharmacy, your medical board and your own counsel.