The semaglutide shortage: What you should know

Ozempic and Wegovy are in short supply and compounding pharmacies are filling the gap. What are the FDA’s concerns? And are patients at risk? Learn more.

The semaglutide shortage: What you should know

Some compounding practices may put patients at risk

Ozempic and Wegovy shortages have many people looking for other options. Compounding pharmacies have stepped in to fill the gap. But what are the risks of compounded semaglutide?

Read on to learn about FDA concerns. And find tips to help your patients minimize risks.


What is semaglutide?

Scientifically speaking, semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. It mimics a hormone produced in the gut in response to food, increasing insulin production and reducing blood sugar. It also creates a feeling of fullness, thereby reducing appetite.

Both Wegovy and Ozempic are once-weekly semaglutide injections. Physicians prescribe Wegovy for weight management. Patients with type 2 diabetes can receive Ozempic prescriptions, although some people use the drug off-label for weight loss.


How does compounding work?

Compounding creates a drug to meet individual patient needs. For example, compounders may reformulate a prescription for a patient with a particular allergy. Or they may change a pill into a liquid form. About 7,500 pharmacies specialize in compounding services in the United States.

The FDA says qualified pharmacies may be able to prepare a compounded version of a drug in short supply. However, these compounded drugs do not separately receive FDA approval. Instead, to create these drugs, qualified pharmacies must meet certain Federal Food, Drug, and Cosmetic (FD&C) Act requirements. This discrepancy results in questions about semaglutide compounding.


What are the FDA’s concerns with semaglutide compounding?

Last May, the FDA reported that it had received accounts of patients experiencing adverse outcomes when using compounded semaglutide drugs.

In that same report, the FDA also noted that some compounders may be using salt forms of semaglutide. This formulation is different from the base semaglutide contained in Ozempic and Wegovy. The FDA says:

  • Salt forms of semaglutide have not been found to be safe and effective.
  • Compounding a drug using semaglutide salts would not meet federal requirements.


Who regulates drug compounders?

The FDA only plays an oversight role in drug compounding. They do not verify drugs’ safety or effectiveness; compounded drugs are not FDA-approved. Instead, state boards of pharmacy regulate compounding practices. Some of these boards have issued semaglutide warnings like the FDA’s.

Novo Nordisk – the manufacturer of Ozempic and Wegovy – is taking legal action to protect U.S. patients. The move targets compounding pharmacies and other entities, such as spas and clinics, that market and sell non-FDA-approved medicines claiming to contain semaglutide.

An important point to note: Patients can’t get compounded drugs straight from a supplier. They need a prescription from a licensed healthcare provider. Any direct-to-consumer offers are not from compounders. They’re likely from questionable entities looking to take advantage of consumers.


How can you help your patients avoid compounding risks?

Navigating the semaglutide shortage is challenging. But you can take steps to reduce risks.

First, if you’re considering working with a compounder, be aware of the FDA’s warning about salt forms of semaglutide. And inform your patients about the FDA concerns. Also, talk with your patients about how they can stay safe. For instance, the FDA cautions:

  • Patients should only get semaglutide drugs with a prescription from a licensed healthcare provider.
  • Patients should only get medicines from state-licensed pharmacies or outsourcing facilities registered with the FDA.
  • Purchasing medicine online from unregulated, unlicensed sources can expose patients to potentially unsafe products.
  • If patients choose to use an online pharmacy, the FDA’s BeSafeRX campaign can help them make safer, more informed decisions.


When might the semaglutide shortage end?

Novo Nordisk says it’s working to increase manufacturing capacity for semaglutide production. Still, it anticipates an ongoing supply disruption for Wegovy.

In the meantime, Novo Nordisk advises:

  • Patients should contact their pharmacy much earlier than usual for refills.
  • Patients should be specific about dose strengths.
  • Healthcare providers should consider the limited supply of Wegovy when starting new patients on therapy and recognize the possibility of disruption in care.


Are there other semaglutide options?

Novo Nordisk offers a third FDA-approved semaglutide – Rybelsus. Adults with type 2 diabetes can take this once-daily tablet to improve their blood sugar levels. As of now, Wegovy is the only semaglutide drug FDA-approved for weight management.

Of note, in October of 2022, another manufacturer, Eli Lilly, received FDA Fast Track designation for tirzepatide as a once-weekly injection for adults with obesity. This designation speeds up the drug submission and review process with the FDA. It also makes the drug one to watch as the Ozempic and Wegovy craze continues.

Add new comment

The comment language code.