Are Compounded Semaglutide and Tirzepatide Safe? Understanding the FDA Warning

Medically reviewed by: Kristin Baier, MD

Given the recent access-related challenges with GLP-1 medications like semaglutide and tirzepatide, it’s understandable that patients are seeking alternative solutions outside of traditional pharmacies and insurance. 

One option that has gained recent popularity is obtaining semaglutide (the active molecule in Ozempic®, Wegovy®, and Rybelsus®)  or tirzepatide (Zepbound® and Mounjaro®) through compounding pharmacies. While the lower price points and immediate access do sound appealing, it’s worth taking a critical look at what’s going on with compounded medication. 

Are compounded semaglutide and tirzepatide the same as the brand names?

Compounded semaglutide and tirzepatide are not identical to the FDA-approved, brand name medications manufactured by Novo Nordisk and Eli Lilly. While semaglutide is the active molecule in both Ozempic® and Wegovy®, and tirzepatide is the same active molecule in Mounjaro® and Zepbound®, there is no guarantee that a compounded version of the medication is the same formulation with the same efficacy, safety, and side effects.

What are compounding pharmacies? 

Compounding pharmacies combine or alter active ingredients or molecules to formulate a unique alternative that can be similar, but not identical to, any given medication. 

The GLP-1 medications Mounjaro®, Zepbound®, Ozempic®, Wegovy®, Saxenda®, and Rybelsus® are all patented. This means that their manufacturers—Novo Nordisk and Eli Lilly—have a patent on the active pharmaceutical ingredient.

A patented drug means only the patent-holder (Novo Nordisk or Eli Lilly) can make and sell the drug for a certain period of time. For semaglutide, Novo Nordisk’s patent extends through 2026. 

Why did the FDA issue a warning for compounded semaglutide and tirzepatide?

During drug shortages, a medication may be compounded if it meets certain criteria set forth by the Federal Food, Drug, and Cosmetic Act. 

As of spring 2023, both Wegovy and Ozempic are on the FDA Drug Shortages list—however, it’s important to note that while a drug may be on this list, it doesn’t necessarily mean it’s completely out of stock at traditional pharmacies. 

When a drug is on this list, it can be compounded and distributed with fewer restrictions until it is deemed by the FDA to no longer be in short supply. What we’re seeing is that some pharmacies and healthcare professionals are trying to capitalize on this loophole—so more compounded semaglutide and tirzepatide are hitting the market.

What are the risks of compounded GLP-1 medications?

The FDA has received reports of adverse events from compounded GLP-1 medications. While they have not disclosed what these adverse events are, they are apparently significant enough that the FDA felt it in the best interest of the public to issue a warning.

Per the FDA, patients need to be aware that some products sold as semaglutide and tirzepatide may not contain the same active ingredient as FDA-approved products and may be the salt formulations of the drug. 

Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective. Patients should only obtain drugs containing semaglutide or tirzepatide with a prescription from a licensed healthcare provider, and only obtain medicines from state-licensed pharmacies or outsourcing facilities registered with FDA.

Calibrate doctors are licensed providers and do not prescribe compounded medications. 

Breaking down the FDA warning

To summarize the above, the FDA has warned that some compounding pharmacies are using salt formulation, such as semaglutide sodium and semaglutide acetate. 

These salts are biochemically different from the base form of semaglutide and tizepatidethat have been FDA approved. It’s unclear where these salt forms are actually coming from but it’s not from an FDA-approved manufacturer. 

It’s important to note that salt variations of GLP-1 medication have not been tested with the same scrutiny or follow-up as the base forms. This means that the safety and efficacy of compounded formulations cannot be guaranteed, leaving patients vulnerable to unknown side effects and adverse reactions that could potentially be different or more significant than what is expected from Zepbound®, Mounjaro®, Ozempic®, Wegovy®, and Rybelsus®. 

The question of quality control and safety practices in the formulation and delivery of compounded GLP-1 medication also needs to be evaluated. Are sterilization practices in place? Has there been any contamination? Are the dispensed needles that come with the medication clean?

The risks posed by these unknowns are not worth the benefit of seemingly easier medication access in light of shortages. For this reason, Calibrate doctors do not prescribe compounded semaglutide or tirzepatide to members. 

Compounded semaglutide and tirzepatide: Key takeaways

• Due to recent shortages of GLP-1 medications including Mounjaro®, Ozempic®, and Wegovy®, we are seeing an increase in production of compounded variations which may not be safe or effective.
• The FDA has issued a warning to patients considering compounded formulations as an alternative to patented drugs Mounjaro®, Ozempic®, and Wegovy® stating that the compounded medication may contain chemical salts, which have not been FDA-tested or approved.
• The FDA suggests patients only seek approved GLP-1 medication (i.e. brand names Mounjaro®, Zepbound®, Wegovy®, and Ozempic®) via a licensed healthcare provider and state-licensed pharmacy.
• Calibrate doctors are licensed healthcare practitioners and only prescribe patented GLP-1 medication as clinically appropriate for each patient as an individual; Calibrate doctors do not prescribe compounded semaglutide or compounded tirzepatide. 

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