What Is Compounded Semaglutide — and Is It Safe?

Weight loss can be overwhelming and exhausting, especially if you’ve tried countless diets and different weight loss approaches. You may be considering weight loss medication as a helpful tool to support your weight loss journey. 

However, weight loss medication can be expensive, especially if your insurance does not cover it. Common names like Ozempic, Wegovy, and Rybelsus can cost hundreds of dollars per month, making them inaccessible to some. 

Compounded semaglutide has become a more accessible option for a wider range of people to receive semaglutide due to its lower cost. But, what is compounded semaglutide, and how can it help you reach your weight loss goals? 

Here, we are going to go over everything you need to know about compounded semaglutide. We’ll review what it is, its safety profile, and the new legal restrictions that may impact your access. 

How Drug Compounding Works

Drug compounding involves pharmacies mixing, combining, or altering ingredients to create customized medications. Now, there are some ways in which the FDA regulates these compounding medications: 

• 503A Pharmacies: They operate under state boards of pharmacy and can compound medications for individual patients who have valid prescriptions. But, they must follow strict guidelines about patient-specific needs. 
• 503B Pharmacies: These are FDA-registered as outsourcing facilities, meaning they can produce larger batches of compounded drugs. They are typically used when there are shortages or for hospitals. 

While most people choose the traditional medication that is available (like choosing Ozempic), some people may need compounding medications for different reasons. For example, some patients may need different dosage forms, they may have allergies to certain ingredients, or require their medications when there is a shortage. 

Semaglutide Shortage Timeline & FDA Ruling (2021-2025)

So, why did some pharmacies start offering compounded semaglutide? 

The semaglutide shortage began in 2021 when there was an increased demand for drugs like Ozempic and Wegovy, far exceeding the supply. During this period, the FDA allowed compounding pharmacies to produce semaglutide versions to help meet patient needs. 

However, this changed dramatically in February 2025 when the FDA officially declared the semaglutide shortage was over. The agency determined that there were sufficient supplies of FDA-approved semaglutide products to meet patient demand. 

Consequently, the FDA has begun sending enforcement letters to compounding pharmacies that continue producing semaglutide products without proper justification. This represents a significant shift in the regulatory landscape of semaglutide products. 

Salt Forms vs Base Form — Safety Red Flag

One of the most concerning issues when it comes to compounded semalgutide is the use of salt forms instead of the base form, which you can find in FDA-approved medications. 

Some pharmacies use semaglutide sodium or semaglutide acetate salts because they are cheaper and easier to work with. However, the FDA considers these different active ingredients to be distinct from the semalgutide base used in approved drugs. 

Why does this matter? 

It all comes down to safety. Salt forms can lead to dosing errors because they have different potencies than the base form. In fact, the FDA has received reports of overdoses and hospitalizations linked to these dosing miscalculations.

If you are concerned about your medication, you can check the medication label or consult your pharmacy directly. Look for terms like “semaglutide sodium” or “semaglutide acetate” rather than just “semaglutide.” And, if you are unsure about your medication, request a certificate of analysis from your pharmacy. 

Cost Comparison: Brand vs Compounded

The price difference between brand-name and compounded semaglutide can be quite substantial. In fact, one of the reasons some people prefer compounded semaglutide over brand-name medication is that it is more affordable. 

Brand-name medications like Ozempic and Wegovy typically cost between $900 to $1,300 per month without insurance. And, even if you have insurance, the copays can be quite high. 

On the other hand, compounded versions used to cost $200-$450 monthly. However, prices are rising following the FDA’s declaration of a shortage, as many compounding pharmacies have stopped producing these medications. This has led other pharmacies to increase their prices due to limited legal production options. 

Keep in mind that when it comes to compounded medications, not all insurance companies will cover their costs. It’s important to speak with your insurance company to understand the policies regarding these medications. 

Legality & Enforcement: 2025 Onward

The FDA is actively pursuing compounding pharmacies that continue selling non-exempt semaglutide products in bulk. This enforcement represents a significant shift from the more permissive stance they had while there was a shortage. 

For example, there is currently a dispute between Novo Nordisk (the maker of Ozempic) and companies like Him and Hers. When Him and Hers announced that they would continue offering compounded semalgutide, its stock price plunged, as investors realized the regulatory risks. 

But what happens to telehealth companies? Can they still ship compounded semaglutide? 

This is going to depend on whether your clinic works with a properly licensed compounding pharmacy that can demonstrate legitimate patient-specific needs (note: we do!). That is why many telehealth companies have stopped offering compounded semaglutide and their concern regarding legal issues. 

How to Tell If Your Pharmacy Is Legit

If you are considering getting compounded semaglutide, it’s important you verify your pharmacy’s credentials. Here are some things to consider when purchasing compounded semalgutide: 

• Check NABP accreditation: The National Association of Boards of Pharmacy maintains a database of accredited pharmacies. Check it out ot help determine if your pharmacy is within this directory. 
• Verify licensing: Ensure that your pharmacy has proper 503A or 503B licensing for the type of compounding they are doing. 
• Request documentation: Ask for a certificate of analysis showing the exact ingredients and potency of your medication. 
• Confirm the medication’s base: Make sure that they are using semaglutide base and not any forms of salt. 
• Verify lot testing: Legitimate compounding pharmacies should provide testing results for each batch they create. 

FAQs

Is compounded semaglutide generic?

No, compounded semaglute is not a generic medication. Generic medications are typically FDA-approved copies of brand-name drugs. However, compounded medications are custom-mixed by pharmacies and sometimes don’t undergo the same approval processes. 

Will compounding resume if another shortage happens?

If the FDA declares another semaglutide shortage, compounding pharmacies will be allowed once again to start manufacturing compounded semaglutide. However, this would require for the FDA to declare an official shortage. 

Does insurance ever cover compounded GLP-1s?

Insurance coverage for compounded medications is typically very limited. Most insurance plans prefer FDA-approved medications and may not cover compounded versions, even then they are legally available. However, if you have some questions regarding your insurance policies, speak with your company to determine if you can get the compounded version. 

Key Takeaways & Next Steps

• Compounded semaglutide is a custom-made medication that was legal during shortages but may not face some restrictions. 
• Legal production of compounded semaglutide is now limited following the FDA’s February 2025 shortage declaration. 
• Salt forms pose a serious safety risk due to dosing differences and potential overdoses. 
• While compounded semaglutide may be cheaper than the brand-name, the costs are now rising since legal production is now more restricted. 
• If you are getting compounded semaglutide, make sure you get it from a verified pharmacy. 

If you are thinking about getting compounded semaglutide, make sure you connect with a licensed tele-health provider that dispenses regulated products. This keeps you safe and makes sure you get high-quality medication that won’t put you at risk. 

You can check with our telehealth professionals to determine if compounded semaglutide is the best way to help you reach your goals. And, if you are thinking about getting compounded semalgutide due to its lower price, check out our brand coupon guide to explore cost-saving opportunities on approved medications. 

Remember that this article is for informational purposes only, and it is not intended as medical advice. Always speak with a healthcare provider to determine what is the best medication to help you cover your goals and needs.