What Are GLP-1 Compounding Formulas, and Are They Safe?

In 2017, the FDA approved semaglutide, an injectable GLP-1 agonist medication sold under the name Ozempic, for the management of type 2 diabetes. Later, the pharmaceutical company that makes Ozempic received approval to market the drug for weight loss under the brand name Wegovy. Since then, other medications marketed to aid weight loss efforts alongside the management of type 2 diabetes—such as tirzepatide, sold under the brand name Mounjaro—have come to market. Now, with the surge in people’s interest in weight loss medication, a supply shortage has developed. 

When there’s a medication shortage, the FDA lifts some regulations to allow compounding pharmacies to essentially duplicate patented medications using a copycat version (note that it is not the same exact formula). The past Ozempic and tirzepatide shortages, in particular, have opened up the floodgates, with companies promising to help you lose weight quickly with their own versions of GLP-1s. But are they safe and effective? Here’s what health experts say.

What Are GLP-1 Compounding Formulas?

GLP-1 stands for glucagon-like peptide-1, a satiety hormone the body produces when we eat to help stimulate digestion and regulate our hunger and fullness. GLP-1 medications help the body mimic the GLP-1 hormone, which helps regulate appetite control, aiding in weight loss while keeping blood sugar stable.  

GLP-1 compounding formulas, on the other hand, combine and/or alter GLP-1 medications and are sold without being as rigorously tested as the FDA-approved medications. Emily Sutton, Pharm.D., CDCES, a clinical pharmacist, shares, “Compounded GLP-1 medications contain a version of the drug (not an exact copy of the FDA-approved drug) that a pharmacy makes. They use their own formulas to create copycat versions of the FDA-approved medications, meaning while the ingredients may be the same, they aren’t necessarily present in the same ratios or amounts, nor sourced from the same FDA-approved facilities.” Sutton expressed that this uncertainty in formulation presents a gray area that cannot be overlooked when it comes to compounded GLP-1 drugs.

Are GLP-1 Compounding Formulas Safe? 

Unfortunately, the simple answer is not so simple. While the active ingredients in GLP-1 medications have been shown to be effective and safe in clinical trials, Sutton says compounded formulas haven’t been tested in the same fashion, and she doesn’t recommend them. Additionally, she notes that there are pharmacies certified to compound injections that follow strict rules for cleanliness, testing and documentation to ensure the safety of the injections; however, the level of oversight ends there. “These medications aren’t FDA-approved and aren’t required to be, so no entity follows up on the safety and effectiveness of the drug,” she says. 

Plus, “compounded versions of drugs introduce some variability into the picture regarding dosing, quality and purity, potentially with added risks, too,” shares Wendy Bazilian, Dr.P.H., RDN, a doctor of public health. “This is where safety can become a gray area—compounded medications may not meet the same stringent guidelines, which may lead to unwanted and unpredictable side effects.”

Risks and Downsides 

Similar to GLP-1 medications, compounding formulas may have serious side effects. Bazilian notes that these include: “Nausea, vomiting, diarrhea or constipation, especially at the start or if adjusting dosing. There are also potential risks for more serious issues, including pancreatitis or gallbladder problems.” She adds that potential complications with your blood sugar levels are another concern. 

Sutton says that those who use compounded GLP-1 medications “may have more side effects and may experience worse side effects than people who use FDA-approved medications. There’s also concern over ingredients not being listed, germs present in the medication or the amount of the drug was either higher or lower than listed.” 

Since compounded formulas are not FDA-approved, you also face other potential risks if you decide to take them. “Inconsistent quality or contamination or variability in formulation (and dosing) could potentially increase the likelihood of these or even unknown side effects or complications,” adds Bazilian. 

Sutton agrees with this, noting, “Because the FDA does not regulate these compounded products for safety and efficacy, they may not even be effective. For example, someone could be sold a compounded GLP-1 lotion. It could potentially not even contain a GLP-1, but even if it did, it could have no actual effect on the body.” 

In fact, the FDA has issued warnings regarding the use of compounding GLP-1 formulas due to safety concerns after adverse events were reported from their use.

As of April 30, 2025, the FDA had received 520 reports of adverse events associated with compounded semaglutide and 480 reports of adverse events with compounded tirzepatide. Keep in mind that these are only the events have been reported; it’s likely an underrepresentation, according to the FDA, since state-licensed pharmacies that are not outsourcing facilities are not required to report events. 

Potential Benefits 

One of the main premises behind compounding drugs is to help meet a person’s individual needs, especially if they can’t tolerate a mainstream drug due to an allergy or complication with the medication and their body. However, compounded GLP-1 formulas are not necessarily a form of personalized medical therapy, and instead fill a void due to shortages of FDA-approved drugs. 

With this in mind, there is a financial factor that can’t be overlooked when it comes to a possible upside to compounding formulas. Since GLP-1 medications are very costly, people may seek a more affordable alternative to meet their needs. Sutton shares, “The FDA-approved injectable weight loss medications can cost over a thousand dollars a month for life and many insurances do not provide coverage. Compounded options may be less expensive and more financially sustainable.” 

While she hesitates to recommend these options, she suggests that if your medical team has agreed to a compounded formula and is monitoring you closely, look to fill the prescription from a 503a pharmacy that employs pharmacists who are board-certified in sterile compounding and follow the best practices when it comes to compounding medications, or from a medical provider that sources its prescriptions from a 503b pharmacy.

Doctor-Recommended Lifestyle Tips to Focus On 

While GLP-1 medications can help with weight loss in the short term, their long-term efficacy and safety aren’t so clear. This makes it extremely important to focus on the entire picture of a healthy lifestyle. Angie Neison, M.D., CCMS, DipABLM, says, “I don’t believe in prescription drugs without the approach of including lifestyle behaviors that also have a wealth of evidence to support a whole-person approach.”

With this in mind, Neison and Bazilian agree that lifestyle and behavior changes are at the forefront of any weight loss program. Keep these tips in mind as you navigate your personal weight-loss journey (with or without GLP-1 compounding formulas):

• Eat a balanced diet, emphasizing nutrient-dense foods high in fiber: A well-rounded diet can help you achieve and maintain weight loss goals in the long term. Building your meals with a mix of lean proteins, high-fiber foods and healthy fats is key. This trifecta of nutrients helps maintain stable energy levels, regulate blood sugar and reduce cravings. In fact, fiber plays such a prominent role in satiety and weight management that it should be incorporated in every meal. Foods like fruits, vegetables, 100% whole grains and even plant-based proteins (like soy foods and beans) add a powerful punch of fiber to your plate. While the Dietary Guidelines for Americans recommend aiming for 25 to 34 grams of dietary fiber daily, most of us aren’t meeting that number. Consider adding some high-fiber fruits alongside your meals.
• Find and incorporate daily movement you enjoy: Exercise is an important part of maintaining your weight loss journey long-term. If you haven’t found a form of movement you enjoy yet, this is your invitation to explore what “moves” you! Dance, yoga, jogging, walking, Zumba or a gym session—whatever it is, find the time to fit it in. Health authorities encourage adults to engage in regular physical activity, aiming for a minimum of 150 minutes per week of aerobic exercise, while incorporating 2 or more days of strength training. This has been shown to have positive benefits not only on health and disease prevention, but also on mood and emotional health. 
• Prioritize sleep hygiene: The hours of Zs you log (or lack thereof) can have a drastic impact on your health. In fact, research shows that inadequate sleep can increase your risk of cardiometabolic diseases, such as obesity, diabetes and heart disease. Making sleep a priority can be challenging, particularly at different life stages. Work with what you have and put down your phone at night. Disconnect from screens and implement a routine that optimizes your time, allowing you to hit your pillow.
• Manage stress mindfully: While stress is inevitable, there are steps you can take to manage it. For instance, incorporating a simple walk outdoors into your routine is an effective way to reduce stress and improve mental health. And, of course, enjoying foods that have been shown to help decrease stress while improving your mental well-being is always a win-win too! 

The Bottom Line

Medical experts do not recommend taking GLP-1 compounding formulas due to safety concerns. Experts recognize the importance of patients feeling supported throughout their weight loss journey. This is why they encourage patients to work directly with their healthcare team to receive the treatment plans necessary to help them improve their lifestyle and nutrition habits, supporting their long-term health. Additionally, further research on newer compounding formulations and their safety is needed to help you achieve your goals without compromising your health along the way.