Will compounded semaglutide be banned?

In this article:

• Concerns with compounded versions
• Will it be banned?
• Future of compounded semaglutide
• The bottom line

In this article

• Concerns with compounded versions
• Will it be banned?
• Future of compounded semaglutide
• The bottom line

A compounded medication is a custom formulation of an existing brand-name or generic drug made by a licensed pharmacist and designed to meet a patient’s unique needs. For example, a person who is allergic to a common dye included in a prescription drug could have a compounded version of the drug made without that dye. More notably, compounded drugs are also made to counteract drug shortages. When there isn’t enough supply of prescription medication to meet patient demand, compounding pharmacies can create similar versions, or copies, of the drug to fill the gap.

Before Ozempic (semaglutide) became a household name, most people probably didn’t think much about compounded medications. Still, Ozempic’s popularity has caused an ongoing shortage of the drug—and compounding pharmacies have ramped up their production of compounded semaglutide, an unofficial alternative that, in theory, has the same active ingredient and works just like the real thing.

“Compounded semaglutide has emerged as an alternative to Wegovy and Ozempic due to its lower cost and greater availability,” says Paunel Vukasinov, MD, internist and obesity medicine specialist with Medical Offices of Manhattan.

But despite its benefits—which include helping patients save money and reducing the strain of supply shortages—compounded semaglutide has raised ethical and safety concerns in the medical community, Dr. Vukasinov says. It has also raised concerns for Ozempic manufacturer Novo Nordisk, which petitioned the U.S. Food & Drug Administration (FDA) in October 2024 to ban compounded formulations of semaglutide.

The FDA hasn’t ruled on Novo Nordisk’s petition yet, but many experts think it will be successful. Here’s what to know, including why compounded semaglutide may be banned and what that means for patients.

Concerns with compounded versions of semaglutide

Compounded medications can be made safely, but many concerns are being raised about compounded semaglutide by healthcare providers and the FDA, which has published several statements warning patients about the potential risks of using compounded semaglutide.

The overarching issue is that compounded medications are not FDA-approved, which means their safety, efficacy, and quality are less predictable, says Dr. Vukasinov.

• Dosing errors: Dosing errors have been reported with the use of compounded semaglutide since these alternative forms require patients to measure out their own doses. In many cases, patients accidentally injected too much of the medication because of inexperience with multi-dose vials. In other cases, healthcare providers didn’t correctly calculate or prescribe the right dose, causing patients to self-administer significantly higher amounts of the drug than recommended.
• Different active ingredients: Some compounding pharmacies are using semaglutide salts in their formulations, which have not been proven safe or effective. In fact, the FDA has told compounding pharmacies not to use the salt forms of semaglutide in their formulations. Dr. Vukasinov says compounded products may also contain other additives or mixed ingredients that can alter the drug’s efficacy or increase side effects.
• Lack of regulations: Compounded semaglutide producers aren’t required to follow the same quality assurance practices as official manufacturers, says Danielle Kelvas, MD, a primary care provider with The HCG Institute in Tennessee. Although compounded semaglutide can be as effective as Ozempic, the exact manufacturing process isn’t the same, so there could be impurities in the medication. “Ozempic went through a rigorous FDA approval process to ensure its safety, efficacy, and quality,” says Dr. Kelvas. “When it’s compounded by a third party, they can skip many of those quality assurance stop signs.”

Despite these concerns, it’s important to note that it’s not currently illegal to produce compounded semaglutide. According to the FDA, compounding pharmacies are allowed to make “copies” of commercially available drugs when they are on the agency’s drug shortages list. As of November 2024, semaglutide is on that list, giving compounding pharmacies the right to make their own versions of the drug. This means some people have the opportunity to take semaglutide who might not otherwise be able to because of shortages or high brand-name costs. If price is driving you to a compounding pharmacy, there are other ways to save, such as using SingleCare coupons.

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Many of the concerns around compounded semaglutide relate to injectable formulations of the drug. However, compounded versions of the semaglutide pill (Rybelsus) also exist and are included in the FDA’s warning statements about compounded semaglutide. Per Dr. Kelvas, the semaglutide pill works well for people with Type 2 diabetes who can’t use injectable medications, so even though the pill is less commonly prescribed than the injectables, people considering compounded semaglutide in pill form should still be aware of the potential risks.

Will compounded semaglutide be banned?

It’s not currently illegal to manufacture compounded semaglutide because it is on the FDA’s drug shortages list. This permits compounding pharmacies to produce their versions in an effort to ease the strain of supply chain issues and exorbitantly high costs.

However, in October 2024, Novo Nordisk formally asked the FDA to ban the production of compounded semaglutide and requested that the agency move the drug to its Demonstrable Difficulties for Compounding (DDC) list.

In other words, Novo Nordisk is claiming that semaglutide is too complex of a drug to be safely compounded, citing patient safety and drug effectiveness as the main reasons why. However, revenue concerns are undoubtedly playing a role in the company’s petition.

“Other companies are making billions off unsafely compounded semaglutide, so there’s good reason [for them to want it banned],” says Dr. Kelvas.

The FDA hasn’t ruled on Novo Nordisk’s request yet or given a timeline for when that ruling might come. However, given the FDA’s concerns about adverse events associated with compounded semaglutide and Novo Nordisk’s efforts to prove that semaglutide is too complex to be safely compounded, there is a good chance the FDA will agree to their request.

The future of compounded semaglutide

If the FDA agrees to Novo Nordisk’s petition and moves semaglutide to the DDC list, it may take some time for a ban on compounded semaglutide to be put into place officially. For example, a recent FDA decision to remove the GLP-1 drug tirzepatide (Mounjaro/Zepbound) from the drug shortages list allows for up to 90 days from the calendar announcement to stop dispensing products. A ban on compounded semaglutide could result in the same response. This means it’s not likely that anyone currently taking compounded semaglutide will be immediately affected by a ban on the drug, assuming it even goes through.

That said, if compounded semaglutide is banned, the decision will have both positive and negative effects, says Dr. Vukasinov. On the plus side, he thinks it will give patients and providers more confidence in the safety, quality, and efficacy of semaglutide products while reinforcing the FDA’s authority to regulate medications and prevent unsafe compounding practices. But it will also present significant challenges: “Patients who rely on compounded versions due to cost or insurance coverage limitations may face difficulties accessing treatment, [and] lower-income patients may be disproportionately affected [because of the] high cost of branded medications.”

Overall, Dr. Vukasinov says the petition will likely protect patients from unsafe formulations but, at the same time, exacerbate issues of affordability and access unless the FDA takes steps to counteract those existing issues.

The bottom line

When made correctly, compounded semaglutide allows people to access a high-cost, in-demand drug that may not normally be accessible to them. However, compounded medications carry additional risks due to their lack of FDA approval. When a drug is extremely popular (like semaglutide), the potential for compounding pharmacies to take advantage of patients increases—they may cut corners with quality or safety to keep up with competitors, and most patients would be unaware of these hidden dangers.

Because the FDA has a responsibility to ensure that people are receiving safe, legitimate medications, its concerns about compounded semaglutide are valid; Novo Nordisk may be successful in persuading the FDA to ban it. But a ban on compounded semaglutide would also limit access to a medication that many people rely on, so unless the FDA also makes an effort to keep approved forms of semaglutide affordable and accessible, banning compounded formulations will pose a challenge for patients and healthcare providers alike.