FDA Announcement
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On Friday Feb 21st The U.S. Food and Drug Administration (FDA) officially removed semaglutide injection products from its drug shortage list, believing there is enough supply to meet patient demand for both Diabetes and Weight Loss patients.⠀⠀
Impact – Potential increase in Drug Costs
This decision has important implications for those who have been receiving compounded versions of the medication.
- Compounding pharmacies were allowed to produce semaglutide while it was on the FDA’s shortage list, despite it being under patent by Novo Nordisk, the manufacturer of Ozempic. With the FDA’s removal of semaglutide from the shortage list, the patent restriction is now back in effect.
- The FDA is now directing that compounded pharmacies may unable to fill these prescriptions after May 22nd,suggesting that patients may need to get their semaglutide supply from Novo Nordisk the maker of Ozempic.
- This MAY increase costs to patients as Novo Nordisk’s monopoly on production allows it to price the drug at approximately $1,000 per month, and unfortunately, it is rarely covered by insurance for weight loss purposes.
Compounding Pharmacies are Challenging in the Courts
We have talked to several compounding pharmacies that we work with, and they are suing the government to fight this decision.
- The compounding pharmacies believe that they will be able to continue to produce less expensive generic semaglutide while the lawsuit is in litigation. However it is unclear how long litigation might last, maybe weeks, maybe years.
- A similar FDA ruling was issued for Tirzepatide, another weight loss drug, in December 2024. In response, compounding pharmacies began compounding Tirzepatide with additional non-active ingredients such as L-carnitine or vitamin B-12 to differentiate their product from the patented drug, Mounjaro, owned by Eli Lilly.
- By compounding the active ingredient of semaglutide with other ingredients, compounders may be able to continue to make the medication at a more affordable price but it is hard to know how future litigation on the matter will go.
Next Steps for Our Patients
Actions you can take
- Schedule an Appointment: If you have been using a compounded version and are concerned about the implications, speak with us about options. Please reach out to us by text or phone at 203-689-0558 and we can book an appointment. The change isn’t coming until May 22nd so there is time to plan.
- Stockpile Medication: If you are concerned about the price of semaglutide increasing if the compounding pharmacies are no longer able to produce the drug, you can order extra supply. The drug can be stored in your fridge for 6+ months before expiring depending on the pharmacies. Please reach out to us by phone or text at 203-689-0558 to order additional medicine.
- Explore other Medication options: There are other medications that are on the market that could be options for you if you are unable to access semaglutide. We can discuss if they would be right for you and allow you to continue your weight loss journey if Semaglutide does indeed become more expensive.
- Tirzapitide
- Trulicity
- Victoza
- Phentermine
- Contrave
- Topamax
- Metformin
Why Was Semaglutide in Short Supply?
- Semaglutide was originally developed to manage type 2 diabetes but gained widespread popularity due to its effectiveness in supporting weight loss.
- As demand surged, shortages occurred, making it difficult for many patients—especially those with diabetes—to access the medication.
- To address this issue, compounding pharmacies began producing their own medications of semaglutide, which were allowed under FDA regulations due to the drug’s official shortage status.
- These “generic” versions are in direct competition with Ozempic, the branded name for semaglutide patented by pharmaceutical manufacturer Novo Nordisk.
The Role of Compounding Pharmacies in Price and Accessibility
- Compounded semaglutide is available at a fraction of the $1,000 per month list price of Ozempic, making the medication more accessible for weight loss purposes.
- Because Novo Nordisk could not meet demand for its brand-name product, it lost sales to compounding pharmacies. The company has since lobbied the FDA to remove semaglutide from the shortage list so it could regain control over pricing and sales.
What Does the FDA’s Decision Mean for You?
With the FDA’s announcement, compounded semaglutide may no longer be permitted after May 22, 2025. Patients currently receiving compounded semaglutide may need to transition to FDA-approved alternatives, likely the more expensive brand names from Novo Nordisk.
- Ozempic (Semaglutide for diabetes)
- Wegovy (Semaglutide for weight loss)
Important Deadlines to Keep in Mind
- April 22, 2025: State-licensed compounding pharmacies and providers must stop producing and distributing compounded semaglutide.
- May 22, 2025: FDA-registered outsourcing facilities must cease production and sales of compounded semaglutide. These are the pharmacies our practice contracts with, and this is the deadline we are currently monitoring.
How This May Affect You?
If you have been receiving compounded semaglutide, we encourage you to take the following steps to ensure a smooth transition:
Potential Challenges
- Cost Considerations: Compounded versions were often more affordable. FDA-approved medications may come at a higher cost, depending on insurance coverage.
- Availability: Although the FDA states the shortage is resolved, local pharmacies may still experience delays due to high demand.
Next Steps for Our Patients
Actions you can take
Schedule an Appointment:
If you have been using a compounded version of Ozempic and are concerned about the implications, speak with us about transitioning to a brand-name medication or exploring alternatives.
Please reach out by text or phone at 203-689-0558 to book an appointment.
Since the change isn’t effective until May 22, there is time to plan.
Stockpile Medication
- If you are concerned about semaglutide price increases, consider ordering extra supply. The drug can be stored in a refrigerator for 6+ months before expiring depending on the pharmacy.
- Contact us at 203-689-0558 to place an order for additional medication.
- Explore other Medication options: There are other medications that are on the market that could be options for you if you are unable to access semaglutide.
If semaglutide becomes too expensive or unavailable, there are other medication options that may work for you:
- Tirzepatide – Recently removed from the FDA shortage list on December 19, 2024. It may face similar price and distribution challenges as semaglutide. Compounding pharmacies have been selling this drug at a significantly lower price than Eli Lilly’s Mounjaro (~$1,200 per month). Our compounding suppliers believe they may be able to continue filling prescriptions while litigation is pending—potentially until June 2025 or later.
- Trulicity – Another GLP-1 receptor agonist used for diabetes management.
- Phentermine – A different class of weight loss medication that may be a suitable alternative.
- Other oral medications including Topamax, Contrave, Metformin could be an alternative.
Final Thoughts
We understand that this change may be concerning for some of our patients, but we are here to help you navigate this transition. Our goal is to ensure that you continue to receive safe, effective treatment without interruption.
If you have any questions or concerns, please reach out to our office as soon as possible to discuss your options. Thank you for trusting us to provide you the best care—we are here to support you every step of the way.
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