Compounded Semaglutide: Is It Safe?

Compounded Semaglutide: Is It Safe?
  • Compounding pharmacies make specialized medications for patients that are different from the mass-manufactured versions of the drugs.
  • With shortages and cost barriers, some people who have been prescribed popular weight loss drugs like semaglutide are turning to compounding as an alternative.
  • It’s important to know that compounded medications are not approved by the FDA. They may not be safe, and they may not work.

Diabetes-turned-weight-loss treatments like semaglutide and tirzepatide work for many people who are prescribed them, but shortages and cost barriers have made it harder for people to keep filling their prescriptions for these life-changing medications. While some patients have been put on alternative dosing schedules as a workaround, others are turning to compounded versions of the weight loss drugs.

But is compounding weight loss drugs safe? Should you take compounded Ozempic? Here’s what experts say.

What Is Compounding?

Compounding pharmacies have worked with healthcare providers to make custom medications for decades, Jennifer Bourgeois, PharmD, a pharmacy expert for SingleCare.

“Although manufactured medications typically are the standard, they don’t always come in the strengths and dosage forms that are right for everyone,” said Bourgeois. “Traditionally, doctors have called compounding pharmacies to fill the gaps.”

A compounding pharmacist can create a specialized drug for a patient based on a provider’s recommendation. For example, if a patient is allergic to an inactive ingredient (like a dye) in a medication they have been prescribed, a compounding pharmacist could make the drug for them without that particular ingredient. The custom-made version is an alternative to a mass-produced and marketed version of the drug that meets a patient’s needs.

Compounding pharmacies can sometimes be called upon to help out when certain medications are in short supply. In these cases, the drug that is in short supply should be compounded to be a copy of the original—not changed in some way, like it would be for a specific patient with a special need.

But it’s not always possible to compound a drug. Even when it is, there are rules, restrictions, and risks that apply to compounded drugs.

Patented drugs like Ozempic, Wegovy, and Mounjaro can only be compounded when the Food and Drug Administration (FDA) declares that there’s a shortage. As of January 2024, semaglutide and tirzepatide are both on the FDA’s list of drugs in shortage, which means they can be approved for compounding if other criteria are also met.

However, getting approved to be compounded is not the same as being an FDA-approved drug. While the FDA can approve a drug to be compounded, it does not oversee the production, check quality, or test the final product for safety and effectiveness.

What are the Risks of Compounded Drugs?

Compounding is not a bad practice, and it can help get needed medications into the hands of patients who rely on them, Rehka Kumar, MD, MS, chief medical officer of Found and former American Board of Obesity Medicine medical director.

Still, it’s not without risk, and concerns about compounded weight loss drugs have already started to crop up.

“Compounded ‘semaglutide’ may contain a salt form of semaglutide not previously studied or tested and its safety and efficacy have not been proven,” said Kumar. “The only FDA-approved manufacturer of semaglutide is Novo Nordisk who has stated that it does not sell the active ingredient to compounding pharmacies.”

If you’re using compounded alternatives to these medications, “you may not be getting what you think you’re getting, and could suffer unnecessary consequences as a result,” said Kumar.

In early January, the FDA issued a warning to consumers about drugs marketed as “semaglutide” that may contain semaglutide sodium and acetate. The FDA had received reports of adverse effects from compounded semaglutide and does not recommend that patients use compounded versions of the drug if they can get the brand-name medication.

In addition to the risk of posing adverse side effects, compounded semaglutide made with these other ingredients isn’t an exact copy of the real drug—so it may not even work. The FDA states that “the salt forms are different active ingredients than is used the approved drugs, which contain the base form of semaglutide,” and that the agency “is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements for types of active ingredients that can be compounded.”

Are Compounding Pharmacies Legit?

Legitimate compounding pharmacies are registered and certified by the state where they physically make medications. However, there are also compounding pharmacies that don’t pass muster.

According to the National Association of Boards of Pharmacy, only about 4% of the 35,000 active online pharmacies currently in operation comply with U.S. pharmacy laws and practice standards. So, how can consumers make sure that their medications are safe?

Bourgeois said that all compounded prescriptions need to be vetted, and patients can be proactive about researching a compounding pharmacy they’re considering using. The FDA’s BeSafeRX program helps patients find out whether their chosen pharmacy is licensed and certified by the Board of Pharmacy in their state, as well as in any state where they provide medications.

Bourgeois added that there are other red flags to watch for, too.

“Semaglutide and tirzepatide are prescription medications. If you can access them without an authorized prescription, that’s a huge red flag,” she said. “If the price is too good to be true, it probably is.”

You’ll get the brand-name drug when you’re prescribed one of these weight-loss medications, but if it’s a compounded version, it will probably come in more generic packaging. However, you still need to be cautious and make sure you know where the medication came from—there are fake versions of these in-demand weight loss drugs out there, too.

According to Bourgeois, the best way to get safe and effective medications is to talk to a healthcare provider you already know and trust. Most providers have relationships with pharmacists that they know to be safe, trustworthy, and licensed.

Takeaway Note

Compounding pharmacies can help out in times of medication shortages and can work with providers to create medications specifically for an individual patient’s need. However, taking compounded weight loss drugs like semaglutide could be risky. Even though the FDA is allowing the drugs to be compounded to address shortages, that doesn’t mean it’s doing quality control on the products. If you’re having a hard time getting your prescribed weight loss medication, talk to your provider.


Most read