Are Compounded GLP-1s Still Allowed? 5 Reasons They Haven’t Gone Away Completely
Key takeaways:
Glucagon-like peptide-1 (GLP-1) medications like semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) were in shortage starting in 2022. During that time, compounded versions of these medications became a more accessible option.
Now that the shortages are resolved, compounded GLP-1s are generally being phased out. But you may still see them for a few reasons, including phase-out periods and workarounds such as non-standard doses and forms.
Compounded GLP-1s are not FDA approved. They were never intended to be a long-term substitute when FDA-approved options are available, except in limited cases with documented medical need. Talk to your healthcare team to determine the safest, most effective treatment for you.
Table of contents
Compounded glucagon-like peptide-1 (GLP-1) drugs gained traction during recent shortages of semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound). But now that the shortages are resolved, you may be wondering if compounded GLP-1s are going away.
The supply of FDA-approved GLP-1s is improving. But there are a few reasons why compounded versions haven’t disappeared entirely. Here’s what’s happening — and what it could mean for you.
What are compounded GLP-1s?
Compounded GLP-1s are customized versions of GLP-1 medications made by a pharmacy. They’re typically created when an FDA-approved version is unavailable, such as during a shortage. Because they’re customized, compounded medications:
Are not FDA approved
Haven’t gone through clinical trials
Aren’t reviewed by the FDA for safety, quality, or effectiveness
In 2022, demand for GLP-1 medications surged, leading to shortages of semaglutide and tirzepatide injections. During this time, compounded GLP-1s quickly grew in popularity as accessible alternatives.
Recently, the FDA announced that these shortages had been resolved. Once a medication is no longer in shortage, compounded versions are generally no longer allowed under normal circumstances. But they may not go away entirely — here are five reasons why.
1. Pharmacies were given a grace period to phase out compounded GLP-1 injections
In late 2024, the FDA announced that the tirzepatide injection shortage had been resolved. This was followed by the resolution of the semaglutide injection shortage in early 2025. But pharmacies weren’t expected to stop compounding these medications overnight.
How to save: Glucagon-like peptide-1 (GLP-1) medications like Ozempic don’t need to break the bank. Explore ways to save on your prescription with this GLP-1 savings guide.
Knowing the risks: Compounded products can help people access certain medications, such as when they are in shortage. Learn more about potential risks before giving compounded semaglutide a try.
GLP-1 comparison: Ozempic (semaglutide) and Zepbound (tirzepatide) are two medications that work in a similar way. Here’s how GLP-1 medications compare.
Instead of requiring an immediate stop to compounding, the FDA allowed grace periods in order to give pharmacies time to phase out these products. These timelines were also subject to specific court rulings, meaning the later of the two dates — FDA deadline or court decision — would apply.
State-licensed compounding pharmacies and physicians: The phase-out periods for compounded semaglutide injections and tirzepatide injections have ended.
FDA-registered outsourcing facilities: The phase-out period for compounded tirzepatide injections has ended. For semaglutide injections, the date is May 22, 2025.
These dates may change if ongoing court cases affect how the FDA’s decisions are enforced.
2. Some healthcare professionals are prescribing custom GLP-1 doses or forms
Some healthcare professionals may prescribe compounded GLP-1s in doses or dosage forms that differ from the commercial products. For example, they might request a lower or higher dose than what’s in Wegovy or Zepbound.
But it’s important to note that FDA guidance says that pharmacies shouldn't compound drugs that are essentially copies of approved medications — unless there’s a clinically meaningful reason for a specific person. This can’t just be a matter of preference or due to cost. It also needs to be clearly documented for that individual. And making small changes, such as a slightly different dose, just to avoid FDA restrictions isn’t permitted.
You may also see compounded versions of non-injectable forms, such as oral or sublingual (under-the-tongue) GLP-1s. These may seem like convenient options, but there are important factors to consider:
Oral semaglutide is already FDA approved as Rybelsus and hasn’t been in shortage. Rybelsus isn’t approved for weight loss yet, but it’s available for people who prefer an oral option. Additionally, it’s not known how well compounded oral semaglutide is absorbed, especially if the ingredients vary from Rybelsus.
Oral tirzepatide hasn’t been studied or approved in oral form. It’s not known how well oral tirzepatide works or how much of the medication, if any, is absorbed.
Sublingual GLP-1s also haven’t been studied in humans, so their absorption, safety, and effectiveness aren’t known.
It’s also worth noting that most GLP-1 medications are still protected by patents. This may further limit how and when compounded alternatives can be used.
3. Some compounded GLP-1s contain extra ingredients
Some compounded GLP-1s include added ingredients such as vitamin B12. The idea is that changing the formula makes the medication no longer an exact copy of the FDA-approved version.
As mentioned above, making small changes solely to get around compounding rules is not allowed, particularly if the added ingredients are available separately in the same, similar, or an easily substitutable strength. Semaglutide injections and B12 injections, for example, are both commercially available and can be administered separately.
Also, these added ingredients haven’t been studied when mixed into the same injection as GLP-1s. This means it’s not fully known how they may affect the safety, absorption, or effectiveness of the compounded drug.
4. The shortage could return and reopen the door to compounding
The FDA’s decision to resolve the semaglutide and tirzepatide injection shortages was based on the current supply levels. But shortages can return — whether due to supply chain issues, manufacturing delays, or another surge in demand. If that happens, the FDA could temporarily allow compounded GLP-1s again.
Some pharmacies may be preparing for that possibility. It’s also possible that ongoing court case decisions could impact the timeline or allow the compounding of GLP-1s to resume. In the meantime, compounded GLP-1s are meant to be phased out in line with recent FDA announcements. They should be reserved for situations where no appropriate commercial product is available.
5. Some people are still using compounds and may need help transitioning to commercial products
Many people began using compounded GLP-1 injections when medications like Ozempic and Mounjaro were in short supply. Some people are still receiving compounded versions, even with the supply stabilizing. In some cases, they haven’t been advised to switch or are facing barriers to accessing the commercial medications.
But switching to an FDA-approved GLP-1 medication isn’t always straightforward. In most cases, you’ll need:
A new prescription for the FDA-approved version
Dose adjustments, especially if you were taking a non-standard dose or form
Insurance approval, which may include a prior authorization or meeting specific eligibility criteria
If you’re currently using a compounded GLP-1, talk to your healthcare team about your options. They can help you initiate the switch to an FDA-approved medication, navigate insurance requirements, and choose the correct dose based on your current regimen.
If cost is a concern, there are several ways to save on FDA-approved GLP-1 medications.
Manufacturer copay cards for Ozempic and Wegovy: If you have commercial insurance, you could pay as little as $0 for Wegovy or $25 for Ozempic with a manufacturer copay card. Wegovy’s price for people who are uninsured or paying cash is $499 for a 1-month supply with the card.
Manufacturer copay cards for Mounjaro and Zepbound: If your commercial insurance plan covers Zepbound, pay as little as $25. If it doesn’t cover Zepbound, the price is as low as $650 for a 1-month supply. Pay as little as $25 for Mounjaro.
Patient assistance programs: Ozempic’s manufacturer offers a patient assistance program that provides the medication at no charge to those who qualify.
Lilly Direct or NovoCare Pharmacy: Zepbound is available as lower-cost vials through Lilly Direct. You could pay $349 (2.5 mg) or $499 (5 mg, 7.5 mg, 10 mg) per month. Wegovy is available through NovoCare Pharmacy for $499 per month.
Good to know: If you've recently switched to an FDA-approved GLP-1 medication, check that you aren't receiving a counterfeit product. Lilly has a barcode scanning tool online to help you verify that you're taking FDA-approved Mounjaro or Zepbound. Using your phone's or computer's camera, scan the barcode on your product. The tool will tell you if it's authentic Mounjaro or Zepbound.
What to know before starting or continuing a compounding GLP-1 medication
If you’re currently using or considering a compounded GLP-1 medication, there are a few important things to keep in mind. These formulations served a purpose while the FDA-approved products were in shortage. But their use is generally more limited now as medications like Ozempic, Wegovy, Mounjaro, and Zepbound have become more widely available again.
Before continuing or beginning treatment with a compounded GLP-1, make sure to:
Ask your prescriber why it’s being recommended. Is it due to cost, availability, or a specific dosage need? Understanding the reason can help you figure out whether a compounded GLP-1 is still right for you.
Confirm whether an FDA-approved alternative is now available. Unlike compounded GLP-1s, commercial medications have undergone FDA review for quality, safety, and effectiveness. If they’re now available, switching may offer more consistency and oversight.
Discuss any safety or dosage concerns. The ingredients and dosage of compounded GLP-1s can vary from the commercial products. It’s a good idea to understand how these differences might affect your treatment.
Remember that FDA-approved GLP-1s are rigorously tested through clinical trials, while compounded versions are not. Compounded GLP-1s can help fill gaps during a shortage. But in most cases, they’re not meant to be long-term substitutes when commercial options are on the market.
The bottom line
Shortages of semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) injections have been resolved. But compounded versions haven’t vanished completely. There are a few reasons why you might still see them being offered, such as phase-out periods and workarounds such as non-standard doses and forms.
Always talk to your healthcare team if you have questions about your treatment plan. They can help you make an informed choice based on the latest guidance, product availability, and your individual needs.
Why trust our experts?
References
Lilly Direct. (n.d.). Authentic Zepbound shipped directly to you.
NovoCare. (n.d.). Ways to save on Wegovy.
U.S. Department of Health and Human Services, et al. (2018). Compounded drug products that are essentially copies of a commercially available drug product under section 503A of the Federal Food, Drug, and Cosmetic Act: Guidance for industry.
U.S. Food and Drug Administration. (2017). The FDA's drug review process: Ensuring drugs are safe and effective.
U.S. Food and Drug Administration. (2020). Frequently asked questions on patents and exclusivity.
U.S. Food and Drug Administration. (2024). FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products.
U.S. Food and Drug Administration. (2024). 7 things to know about drug shortage management.
U.S. Food and Drug Administration. (2025). FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize.
