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Are compounded GLP-1s safe?

What you should know if you’re considering compounded semaglutide, liraglutide, tirzepatide, or other GLP-1s
Gerardo Sison medical writer headshot
By | Feb. 14, 2025
A stack of books and a stethoscope with a healthcare provider's hands in the background: Are compounded GLP-1s safe?

Key takeaways

  • Compounded GLP-1 agonists may be cheaper and more available than brand-name versions but lack FDA approval, raising safety and quality concerns.

  • Compounded medications carry risks like contamination, incorrect dosing, and unpredictable results compared to approved medications.

  • Side effects with compounded GLP-1 products may include nausea, vomiting, and rare but serious conditions like pancreatitis.

  • For safer alternatives, consider FDA-approved medications and explore savings options if cost is a concern.

In this article:

Glucagon-like peptide-1 receptor agonists, commonly known as GLP-1 agonists, are medications often used to help people lose weight and control blood sugar. These drugs, which include Ozempic, Wegovy, and Mounjaro, are relatively new and have received a lot of attention for their weight-loss effects. However, with high demand comes shortages and high costs for some people. 

As a result, many people look for cheaper options or ways to skip the shortage wait, which is where compounded GLP-1s come in. Compounded drugs are custom-made versions of brand-name medications that are often easier to get and may cost less. However, making and using compounded medications is not as straightforward as some might expect it to be. Read on to learn more about the safety of compounded GLP-1s and the risks behind using them.

What are compounded GLP-1 agonists?

Compounded GLP-1s are unique versions of their brand-name counterparts. Examples of brand-name GLP-1 agonists include the following:

These medications are often prescribed to help manage diabetes or obesity. However, regular pharmacies don’t make them. Instead, special compounding pharmacies create these medications. As a result, they’re not the same as medicines approved by the Food and Drug Administration (FDA). 

When FDA-approved GLP-1s are hard to find, compounded versions can fill the gap. They can also be cheaper than brand-name options. But there’s a catch. Compounded GLP-1s aren’t checked by the FDA for safety or how well they work. 

Are compounded GLP-1s safe?

To answer whether compounded GLP-1 products are safe, we have to first look at the drug compounding process. 

Compounded GLP-1 agonists are made by pharmacies that personalize medications for individual patients. For example, a licensed pharmacist might change a medicine from a pill to a cream that can be applied to the skin, or they might make a medication without certain ingredients if the patient has a drug allergy.

The process starts with obtaining the active pharmaceutical ingredient (API), the key component that makes the drug work. Medications need to be prepared in a clean and controlled environment to prevent contamination and ensure that the medication matches what the healthcare provider ordered.

There are two main types of compounding pharmacies: 503A and 503B. 503A pharmacies create medications based on specific prescriptions and are mainly regulated by state authorities. In contrast, 503B outsourcing facilities follow stricter federal guidelines similar to those used by large drug manufacturers. This means they have to meet higher standards for production and quality control. 

However, there are concerns about where compounding pharmacies get their APIs, as major drug companies do not supply them. Often, these pharmacies have to get their raw materials from contract manufacturers, which may be located abroad. This situation leads to concerns about the quality and safety of these ingredients, as standards can differ significantly from one country to another.

While compounded GLP-1s might seem like a quick fix, they come with risks. It’s best to talk to a prescribing healthcare professional about FDA-approved options instead.

Compounded GLP-1 drugs vs. Ozempic and other brands

Compounded GLP-1s and brand-name drugs like Ozempic have some key differences. Although the compounded versions may have identical active ingredients as brand-name ones, they might contain different inactive ingredients. Inactive ingredients in compounded GLP-1 products may affect factors such as absorption, stability, and overall efficacy of the medication.

Cost and availability are other factors. Compounded GLP-1s are usually cheaper, which makes them more appealing to some people. In addition, compounded drugs may be easier to get due to the limited availability of brand-name versions. Compounded versions have become more widespread to fill this gap.

The FDA is keeping an eye on compounded GLP-1s. They’re mainly meant for emergencies during drug shortages, not as regular alternatives to approved drugs.

Risks of compounded GLP-1 drugs

While compounded GLP-1s can be effective for many people, they also come with several potential dangers. These risks range from unexpected side effects to quality and dosing issues.

Reported side effects

If you use compounded GLP-1s, you may experience various side effects. Nausea and vomiting are common complaints with compounded and brand-name GLP-1 agonists. Other side effects include diarrhea, constipation, headaches, and dizziness.

In rare cases, more serious problems can develop. These might include allergic reactions or inflammation of the pancreas (pancreatitis). The risk of these adverse events may be higher with compounded versions, as they lack the same testing as FDA-approved drugs.

Quality concerns

The quality of compounded GLP-1s can vary widely across local and online pharmacies. Unlike FDA-approved drugs, these medicines don’t undergo strict testing, so their safety and effectiveness are less certain.

Compounding pharmacies may not follow the same rules as big drug makers. Some might cut corners to save money, leading to products that don’t meet high quality standards. There’s also a risk of getting fake or substandard ingredients from unreliable suppliers.

Dosing errors

Getting the right dose of compounded GLP-1s can be difficult. These drugs often come in vials instead of pre-filled pens, so you may have to measure your own doses. Compounded GLP-1s may not come with clear instructions either, which makes it hard for people to know how much to take. Taking too much or too little can cause side effects.

Different batches of the same drug might have different strengths. This can make it hard to keep a steady dose over time. As a result, inconsistent dosing can affect how well the medicine works.

Stability issues

Compounded GLP-1s may not stay stable for as long as FDA-approved versions do. They might break down faster, especially if they’re not stored properly. Heat, light, and humidity may cause them to become less effective. Pharmacies might not always provide the right storage info, so you might not know how to store the medicine safely at home.

Contamination

Contamination is a potential worry with compounded products. Bacteria or other harmful substances might get into the medicine during mixing, which can happen if the pharmacy doesn’t maintain sterility or if pharmacy workers aren’t careful.

Contaminated GLP-1s can cause infections or other health problems that could lead to hospitalization in severe cases. In addition, regular testing for contaminants might not occur in all compounding pharmacies. As a result, it may be hard to catch problems before the drug reaches patients.

Variability in formulation

Each batch of compounded GLP-1s might differ slightly, as they’re typically made in small amounts, often by hand. The exact mix of ingredients can vary from one batch to the next. This variability can affect how well the drug works and change the side effects you might experience.

Compounding pharmacies might also use different recipes or methods, making it difficult to compare products from different pharmacies and switch between pharmacies, which is something people may consider when comparing costs.

Mislabeling of ingredients

There’s a risk of compounded GLP-1s being mislabeled. For example, the label might not list all the ingredients correctly, or it may list wrong information about the strength of the medicine. This can be dangerous for people with allergies, as they might take something they’re allergic to without knowing. Wrong labels can also lead to dosing mistakes. 

Interactions with other medications

Compounded GLP-1s might interact with other drugs in unexpected ways. These interactions could be different from those seen with FDA-approved versions since the exact mix of ingredients can vary. Some interactions could make other medicines work less well, while others might increase the risk of side effects. In some cases, drug interactions could be dangerous.

The risks of compounded GLP-1s can vary from person to person and depend on where you get the medication. The best way to prevent risks is to talk to your healthcare provider about your options and choose a trustworthy pharmacy.

Does insurance cover compounded GLP-1s?

Insurance doesn’t often cover compounded GLP-1s, especially when prescribed for weight loss. Weight-loss medications, whether compounded or FDA approved, can be expensive and are often labeled for cosmetic, not medical purposes. However, a lack of FDA approval is a key reason many insurance plans won’t pay for compounded GLP-1 agonists.

Still, insurance plans can vary. Many insurance plans may cover compounded medications if they’re deemed medically necessary and there’s no other suitable alternative. Some people may find they’re able to get reimbursed for compounded medications. However, insurance plans may be more likely to cover compounded GLP-1 medications when they are prescribed for diabetes treatment instead of for weight management. 

It’s best to consult your insurance company directly to see whether they’ll cover your medication. In many cases, people look to take compounded GLP-1 agonists because they don’t have insurance coverage for compounded drugs. That’s because the out-of-pocket costs of compounded GLP-1 agonists can be much cheaper than paying out-of-pocket for brand-name versions. 

For those worried about cost, there may be ways to save on FDA-approved GLP-1s, such as:

  • Checking for manufacturer coupons 
  • Asking about patient assistance programs 
  • Trying a prescription discount program
  • Comparing prices at different pharmacies

RELATED: How to save on Zepbound │ How to save on Wegovy

It may be more helpful in the long run to try these savings options, as compounded GLP-1s may become less available. Drug shortages might ease, and the FDA might also limit their use.

Alternatives to compounded GLP-1s

People with Type 2 diabetes or those looking to lose weight may have safer options than compounded GLP-1s. FDA-approved medications are typically the best choice. These drugs have been tested for safety and effectiveness.

FDA-approved versions of GLP-1 agonists include Ozempic (semaglutide), Mounjaro (tirzepatide), and Rybelsus (oral semaglutide). If cost is a concern, you can also discuss other alternatives with a healthcare provider. For example, other weight-loss drugs include:

There are also numerous alternatives to GLP-1s that are approved specifically to manage blood sugar levels in people with Type 2 diabetes. These medications include:

While medications may be helpful for managing weight and diabetes, lifestyle changes are also key in any treatment plan. These medications are not typically recommended without an appropriate diet and exercise plan. Other lifestyle changes might include getting enough sleep, managing stress, and cutting down on alcohol. 

Bottom line

Compounded GLP-1 medications might seem like a cheaper option compared to well-known drugs like Ozempic and Wegovy, but they come with serious safety and quality risks. These compounded drugs are not approved by the FDA, which means their ingredients and dosages can vary, increasing the chances of problems like contamination or unexpected side effects. 

Even though they might cost less at first, their lack of strict testing makes them less trustworthy than FDA-approved medications. It’s better to look into approved options for safer and more reliable choices. If cost is a concern with brand-name drugs, you can look into patient assistance programs or prescription discount cards. Still, you should always ask a healthcare provider for advice, whether you’re using a compounded drug or brand-name versions of the drug.