Key takeaways:
Zepbound is an FDA-approved tirzepatide injection for weight loss. Compounded tirzepatide products are custom-made by compounding pharmacies and aren’t FDA approved.
Zepbound has been evaluated in large clinical trials to show that it’s safe and effective. Compounded tirzepatide hasn’t been studied the same way, and its quality can vary depending on the pharmacy.
Compounded tirzepatide may be appropriate in limited situations, such as if you’re allergic to an ingredient in Zepbound. But it carries additional risks that are important to understand.
Subscribers to GoodRx for Weight Loss can access FDA-approved brand-name GLP-1 medications like Zepbound.
Save on related medications
If you’ve been exploring options for weight-loss medications, you may come across both Zepbound and compounded tirzepatide. Since they share the same active ingredient, it’s easy to assume they’re interchangeable. But there are important differences between an FDA-approved medication like Zepbound and a compounded product.
Understanding how Zepbound and compounded tirzepatide compare can help you have a more informed conversation with your healthcare team. Here are five key differences between these medications to consider.
1. Zepbound is FDA approved, while compounded tirzepatide is not
FDA approval is one of the biggest differences between Zepbound and compounded tirzepatide. Zepbound is FDA approved. Compounded tirzepatide, on the other hand, is made to meet individual needs and doesn’t go through the same approval process.
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Zepbound is an FDA-approved prescription injection for weight loss. FDA approval means that it has been reviewed for safety and effectiveness, labeling, and manufacturing quality before being made available to the public.
Compounded tirzepatide products are made by compounding pharmacies. They aren’t required to go through the FDA-approval process. But this also means that they aren’t evaluated the same way as Zepbound.
2. Zepbound has been studied extensively, and compounded tirzepatide has not
Zepbound’s safety and effectiveness are supported by data from large clinical trials. Compounded tirzepatide products don’t have this level of evidence.
Zepbound was approved based on clinical trials involving thousands of participants. These trials helped establish how well it works, common side effects, dosage schedules, and more. Everyone in the trials got the same, consistent formulation.
Compounded tirzepatide products can vary from pharmacy to pharmacy, including their ingredients and how they’re made and dispensed, which makes large, standardized studies difficult. This doesn’t necessarily mean compounded products don’t work or are unsafe. But you can’t assume they’ll produce the same results as Zepbound.
3. Compounded tirzepatide may come in dosage forms and doses different from Zepbound
Zepbound is available in standardized injectable forms. Compounded tirzepatide may be prepared in different doses and dosage forms, including injections and oral pills or drops.
Zepbound is supplied as a single-dose prefilled injection pen and a single-dose vial. Its labeling contains a defined dosage schedule that was studied in clinical trials. Zepbound doses range from 2.5 mg to 15 mg.
Compounded tirzepatide, by contrast, can be custom-made into additional doses and forms. For example, your prescriber may consider a custom compounded dose of tirzepatide if you’re not able to tolerate Zepbound doses. However, Zepbound vials can also be used to provide non-standard doses, if needed.
Oral tirzepatide pills and drops are also being compounded. But these forms haven’t undergone clinical trials or been evaluated by the FDA. There are currently no FDA-approved oral tirzepatide products, so it isn’t clear how well these formulations work or what a standard dose would be.
How to save: Glucagon-like peptide-1 (GLP-1) medications don’t need to break the bank. Explore ways to save on Wegovy, Ozempic, Zepbound, and other GLP-1 medications.
Making the switch: Are you switching from a compounded GLP-1 to an FDA-approved brand-name GLP-1? Here’s how to navigate the process.
Can you get GLP-1s online? Depending on where you live, you can get evaluated for a GLP-1 prescription online by a licensed healthcare professional. We’ll review how the process typically works.
4. Zepbound and compounded tirzepatide may contain different ingredients
Both Zepbound and compounded tirzepatide contain tirzepatide as the active ingredient. However, Zepbound also contains consistent inactive ingredients that were reviewed as part of the FDA-approval process. Compounded tirzepatide may include different or additional substances.
In addition to tirzepatide, Zepbound contains ingredients that make injections less painful, keep it stable, and adjust acidity. It’s also packaged and stored according to manufacturer guidelines to help protect the medication and maintain its quality.
Compounded tirzepatide may include added ingredients, such as vitamin B12 or other substances. These additions aren’t part of the FDA-approved product and haven’t been reviewed together with tirzepatide in trials. Storage and handling instructions may also differ depending on the pharmacy and formulation.
5. Zepbound is manufactured under strict FDA standards
Zepbound is produced under strict FDA manufacturing requirements, while compounded tirzepatide is regulated differently.
Zepbound is manufactured in FDA-registered Eli Lilly facilities that must meet rigorous standards for quality and consistency. These standards help ensure that each dose is manufactured the same way every time.
Traditional compounding pharmacies are primarily regulated by state Boards of Pharmacy. Because compounding practices can vary between pharmacies, the quality and consistency of compounded tirzepatide products may differ by location. Some compounding pharmacies, known as outsourcing facilities (or 503B), are registered with the FDA and follow stricter manufacturing requirements.
How to choose
Choosing between Zepbound and compounded tirzepatide depends on your medical needs. It’s a decision best made with your healthcare team.
Zepbound is a good choice for most people. That’s because it’s FDA approved, has been studied extensively, and is manufactured under strict quality controls. These factors make its effects and side effect profile more consistent and predictable.
In limited situations, compounded tirzepatide may be considered. This can include cases where someone can’t tolerate an inactive ingredient in Zepbound or needs a customized approach that isn’t available with the commercial product. However, compounded medications also have unique risks since they’re not FDA approved.
Here are a few considerations to discuss with your healthcare team:
Your medical history and treatment goals
Whether an FDA-approved option is appropriate and available to you
The potential risks and limitations of compounded medications
Together, you can weigh the benefits and risks and choose the option that best fits your situation.
Good to know: The manufacturer of Zepbound has a barcode scanning tool online to help you verify that the medication you're taking is legitimate. Using your phone's or computer's camera, scan the barcode on your product. The tool will tell you if you have authentic Zepbound.
How to save on Zepbound
Some people may turn to compounded tirzepatide due to cost concerns. But there are ways to save on Zepbound, including GoodRx coupons, manufacturer copay savings cards, and direct pharmacy programs.
Save with GoodRx. With a free GoodRx coupon, you could pay as little as $1071.14 at certain pharmacies. Subscribers to GoodRx for Weight Loss can also access FDA-approved brand-name GLP-1 medications like Zepbound.
Save with a copay savings card. If you have commercial insurance that covers Zepbound, you could pay as little as $25 for a 1- or 3-month supply of Zepbound pens. If your plan doesn’t cover Zepbound, pay as little as $499 for a 1-month supply.
Save with a direct pharmacy program. Lower-cost single-dose Zepbound vials are available through LillyDirect for $299 (2.5 mg), $399 (5 mg), and $449 (7.5 mg, 10 mg, 12.5 mg, and 15 mg) per month.
The bottom line
Zepbound and compounded tirzepatide both contain tirzepatide. But they aren’t exactly the same due to differences in FDA approval and quality oversight. They can also differ in their ingredients, doses, and dosage forms.
Zepbound is an FDA-approved injection for weight loss. Compounded tirzepatide products are custom-made versions that aren’t FDA approved. Understanding these differences can help you make a more informed decision with your healthcare team.
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References
U.S. Food and Drug Administration. (2022). Information for outsourcing facilities.
