Is Semaglutide Still in Shortage?

The Reasons Behind the Semaglutide Shortage

The shortage of semaglutide stems from a combination of surging demand, production limitations, and widespread off-label use. As its popularity grows for both diabetes management and weight loss, manufacturers struggle to keep pace, while supply chain disruptions further complicate production. Additionally, the rise in off-label prescriptions has intensified the imbalance between availability and need, leaving many patients facing delays in accessing this critical medication.

Escalating Demand for GLP-1 Medications

The surge in semaglutide demand can be attributed to its dual benefits: effective glycemic control in type 2 diabetes patients and substantial weight loss in individuals with obesity. Clinical studies have demonstrated that semaglutide significantly reduces body weight and improves cardiovascular outcomes, making it a preferred choice among healthcare providers and patients.​

Manufacturing Constraints and Supply Chain Disruptions

Novo Nordisk faced challenges in scaling up production to meet the soaring demand. The manufacturing process for semaglutide is complex, involving sophisticated techniques to ensure the drug's stability and efficacy.

Additionally, global supply chain disruptions, exacerbated by the COVID-19 pandemic, impacted the availability of raw materials and delayed production timelines.​

Off-Label Prescribing Practices

The off-label use of semaglutide for weight loss further strained the supply. Although primarily approved for type 2 diabetes management, healthcare providers increasingly prescribed semaglutide for obesity treatment, leading to a mismatch between supply and demand.​

FDA's Resolution of the Semaglutide Shortage

The shortage is now over. The FDA says there is enough semaglutide for everyone who needs it. Compounding pharmacies can still make it for a short time but must soon stop. Patients can now get the name-brand medicine easily again.

This section explores the FDA’s decisions regarding this issue in detail.

Official Declaration

On February 21, 2025, the FDA declared that the shortage of semaglutide injection products had been resolved. This decision was based on Novo Nordisk's confirmation that its manufacturing capacity could now meet both current and projected national demand.​

Implications for Compounding Pharmacies

During the semaglutide shortage, compounding pharmacies played a critical role in bridging the supply gap by preparing compounded versions of semaglutide. Now that the U.S. Food and Drug Administration (FDA) has declared the shortage resolved as of February 21, 2025, the agency has announced a grace period for compounders. 

For state-licensed pharmacies and physicians under Section 503A, compounding may continue until April 22, 2025. 

For outsourcing facilities under Section 503B, the deadline is May 22, 2025, or until the district court rules on a pending legal challenge—whichever comes later. After these dates, compounding semaglutide that is essentially a copy of an FDA-approved product will no longer be allowed under federal law unless a new shortage occurs.

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The Role of Compounding Pharmacies During the Shortage

When commercial supplies ran low, compounding pharmacies filled critical gaps by preparing semaglutide for patients in need. Though unapproved, these compounded versions kept treatment accessible until regular supplies returned.

Bridging the Supply Gap

Compounding pharmacies, operating under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, were permitted to compound semaglutide during the shortage to ensure patient access. These pharmacies customized medications to meet specific patient needs, providing a vital service during the period of limited commercial availability.

Legal and Safety Considerations

While compounded medications are essential in addressing shortages, they are not FDA-approved and may carry risks related to sterility, potency, and efficacy.

The FDA has expressed concerns about the safety of compounded semaglutide, especially given reports of adverse events associated with off-brand versions. As a result, the FDA has set deadlines for compounding pharmacies to halt the production of compounded semaglutide, emphasizing the importance of patient safety and regulatory compliance.

Current Status of Semaglutide Availability

The resolution of the semaglutide shortage had a significant impact on both market dynamics and pricing. This section explores the key changes that occurred.

Enhanced Manufacturing Capabilities

Novo Nordisk has made significant investments to bolster its manufacturing capacity, including an $11 billion acquisition of manufacturing sites to address production bottlenecks. These efforts have contributed to the resolution of the shortage and improved drug availability.

Market Dynamics and Pricing

The resolution of the shortage has influenced market dynamics, with companies expanding their offerings to include branded weight-loss drugs such as Eli Lilly's Zepbound (tirzepatide). Additionally, Novo Nordisk has reduced the price of Wegovy to enhance accessibility and compete effectively in the growing obesity treatment market.

Bottom Line

The resolution of the semaglutide shortage marks a turning point in the availability of this highly sought-after medication. With Novo Nordisk scaling up production and the FDA lifting its shortage designation, patients can now access semaglutide more reliably. 

While compounding pharmacies played a crucial role in bridging the supply gap, their ability to produce semaglutide will soon be limited under federal regulations. Moving forward, the focus shifts to maintaining stable supply chains, addressing ongoing demand, and ensuring affordability for those who rely on this medication for diabetes management and weight loss.