End of Semaglutide Shortage: FDA Deadline for Compounders Set

Semaglutide Shortage Resolved: What This Means for Patients and Compounders

In a significant progress for the pharmaceutical landscape, the U.S. Food and Drug Administration (FDA) has declared the shortage of semaglutide injection products,the active ingredient in the glucagon-like peptide 1 (GLP-1) medications Wegovy and Ozempic,officially resolved after the shortage began in 2022. This decision has far-reaching implications for compounding pharmacies, telehealth companies, and patients relying on these medications for diabetes management and weight loss.

impact on Compounding Pharmacies

The FDA’s proclamation directly affects compounding pharmacies that have been manufacturing compounded versions of semaglutide during the shortage. These pharmacies, many of which saw a surge in sales, are now required to cease production of these “copycat versions.” Previously, compounding was permitted under specific conditions, such as when an FDA-approved drug was in shortage and unavailable. With Novo Nordisk’s Wegovy and Ozempic no longer on the shortage list, this exception is no longer valid.

The FDA is providing a grace period to minimize disruption for patients. Pharmacies have until April, and outsourcing facilities until May, to comply with the new regulations.

Novo Nordisk’s Response and Increased Production

Novo Nordisk, the manufacturer of Wegovy and Ozempic, welcomed the FDA’s decision. According to a statement, “We are pleased to share that the FDA has updated the status of Wegovy to “Resolved” on their drug shortage website, indicating that the supply of this prescription-only GLP-1 medicine now meets or exceeds current and projected demand in the US and that all doses of Wegovy are being shipped regularly to our customers.”

The company has been actively scaling up its manufacturing capacity to meet the growing demand. This includes a considerable $6.5 billion investment to increase production in the U.S. in 2025.

Transitioning Patients and Potential Challenges

The resolution of the semaglutide shortage brings both opportunities and challenges. Scott Brunner, CEO of the Alliance for Pharmacy Compounding, raises concerns about the potential premature nature of the FDA’s decision, noting that the American Society of Health-system Pharmacists (AHSP) still lists semaglutide and tirzepatide as being in shortage.

brunner also questions whether the FDA has adequately considered the demand for compounded drugs, stating, “And I do question whether in resolving the shortage FDA has taken into account demand for the compounded drug.”

A significant concern is the transition of patients from compounded semaglutide to FDA-approved versions. “The number of patients who’ll need to be transitioned from compounded version to FDA-approved version – that’s likely hundreds of thousands of patients. There’s likely to be some sticker shock for many, and whether they’ll be able to continue to afford the therapy remains to be seen,” Brunner noted.

Despite these concerns, Brunner praised the FDA for providing an “off-ramp” to help transition patients, adding that, “That period […] can definitely help avoid an interruption of therapy for many patients.”

What This Means for Patients

• Access to Medication: Patients should now have improved access to FDA-approved Wegovy and Ozempic.
• Potential Cost Changes: The transition from compounded drugs to brand-name medications may result in higher costs for some patients.
• Consultation with Healthcare Providers: Patients currently using compounded semaglutide should consult with their healthcare providers to discuss transitioning to FDA-approved alternatives.

The Broader Context: Tirzepatide and GLP-1 Medications

semaglutide is not the only GLP-1 receptor agonist to be removed from the FDA’s shortage list. Tirzepatide, the active ingredient in Eli Lilly’s Mounjaro and also found in compounded versions of Ozempic, was removed in December 2024. The deadline for compounding pharmacies to cease manufacturing compounded tirzepatide has already passed, while outsourcing facilities had until March 19 to comply.

Investment Implications

Telehealth company Hims & Hers that offers compounded semaglutide, saw shares tumble 26% showing the possible long term ramifications for investors and the telehealth industry.

Conclusion: Navigating the Transition

the resolution of the semaglutide shortage marks a pivotal moment for patients, compounding pharmacies, and manufacturers. While increased availability of FDA-approved medications is a positive development, challenges remain in ensuring a smooth transition and affordable access for all patients. If you are currently using compounded semaglutide, consult with yoru healthcare provider to discuss your options and ensure continuity of care. Stay informed and advocate for policies that promote affordable access to essential medications.

What are teh implications of the resolution of the semaglutide shortage for patients relying on compounded versions of the drug?

Semaglutide Shortage Resolved: Navigating the New Landscape with Expert Insights

Welcome, Dr. fighting

Today, we’re joined by Dr. Emma thorp, a renowned pharmacist and spokesperson for the Alliance for Pharmacy Compounding, to discuss the recent resolution of the semaglutide shortage and its implications for patients and compounding pharmacies.

recap of the Semaglutide Shortage Resolution

The U.S. Food and Drug Administration (FDA) has declared that the shortage of semaglutide injection products is officially resolved. What does this mean for the pharmaceutical landscape, Dr. Thorp?

Dr.Thorp: The resolution of the semaglutide shortage is indeed significant.It means that patients should now have improved access to FDA-approved Wegovy and Ozempic. However, it also brings challenges, especially in transitioning patients from compounded drugs to brand-name medications.

The Impact on Compounding Pharmacies

Compounding pharmacies have been manufacturing compounded versions of semaglutide during the shortage.How will the FDA’s new regulations affect these pharmacies?

Dr. Thorp: Compounding pharmacies will indeed face changes. They are now required to cease production of compounded semaglutide by April. This means they need to transition their patients to FDA-approved alternatives and possibly shift their business models.

Novo Nordisk’s Response and Production Increase

Novo Nordisk, the manufacturer of Wegovy and Ozempic, has welcomed the FDA’s decision. Can you tell us more about their response and plans for increasing production?

Dr. Thorp: Novo Nordisk is pleased with the FDA’s decision. They’ve been actively scaling up manufacturing capacity to meet growing demand and have invested $6.5 billion to increase production in the U.S.this year. This is great news for patients, as it should lead to improved access and consistency in supply.

Transitioning Patients: Challenges and Concerns

Transitioning hundreds of thousands of patients from compounded semaglutide to FDA-approved versions presents both opportunities and challenges.Could you elaborate on these, Dr. Thorp?

Dr. Thorp: Certainly. One key concern is affordability. While the transition period provides an “off-ramp” for patients,some may face sticker shock when transitioning to brand-name medications.We need to ensure that patients can continue their essential therapies without financial barriers.

Navigating the Transition: Advice for Patients

What advice would you give to patients currently using compounded semaglutide?

Dr. Thorp: I would advise patients to consult with their healthcare providers to discuss their transition options. They should also stay informed about any changes in their medication coverage and speak up if they face affordability issues.

Looking Ahead: The Broader context and Tirzepatide

Semaglutide is not the only GLP-1 receptor agonist to be removed from the FDA’s shortage list. How does the resolution of the semaglutide shortage tie into the broader context of GLP-1 medications and the shortage of tirzepatide?

Dr. Thorp: Indeed, tirzepatide, the active ingredient in Eli Lilly’s Mounjaro, was also removed from the FDA’s shortage list late last year. The transition process for patients using compounded tirzepatide is already underway.These developments highlight the importance of a well-functioning drug supply chain and the need for ongoing dialog between regulators, manufacturers, and healthcare providers.

thoughts for the Future: Lessons from the Semaglutide Shortage

As we navigate this transition, what lessons can we learn from the semaglutide shortage that might help us better prepare for future pharmaceutical supply challenges?

Dr. Thorp: One key lesson is the importance of open communication and collaboration among all stakeholders in the healthcare ecosystem. Regular dialogue between regulators, manufacturers, pharmacists, and patients can help us anticipate and address potential shortages more effectively. Another is the need for policies that promote affordability and ensure patients can access essential medications consistently.