Semaglutide Compound Restrictions: FDA Ends Compound Versions of Ozempic® & Wegovy®: Here Are Available Options
FDA Declares End to Semaglutide and Tirzepatide Shortage, Restricting Compounding Production of the GLP-1s for NJ Residents Using These Medications for Weight Loss
May marks a significant transition for many people on weight loss medications across New Jersey. As the FDA's April 22nd deadline for many compounding pharmacies has passed and the May 22nd deadline arrives for small compounding pharmacies to stop producing semaglutide, many people in NJ on these medications are left wondering if the brand name medications Wegovy®, Ozempic® (semaglutide) and Zebound® (tirzepatide) are options for them moving forward.
FDA Restrictions on Compound GLP-1 Medications
This regulatory action follows the FDA's February 2025 declaration that the semaglutide shortage is officially "resolved." For compounded tirzepatide (Zepbound®), the deadline was earlier - March 2025. Novo Nordisk, the manufacturer of semaglutide now says all doses are "continuously shipped" to meet U.S. demand, removing the legal basis for compounding these medications under current regulations.
Alternative Options to Compound Weight Loss Medications
The popularity of compounded GLP-1 medications stemmed primarily from their affordability—typically $100-$200 monthly compared to more than $1,000 for brand-name versions. This price advantage made weight management accessible to many people whose insurance wouldn't cover the brand medications. With compounded options ending, here are a few alternatives to consider:
- Brand-Name GLP-1 Medications: According to the New York Times, Eli Lilly and Novo Nordisk now offer their brand-name drugs for approximately $500 a month to people who pay out-of-pocket instead of going through insurance. While still more costly than compounded versions, this represents a significant reduction from the previous price point of more than $1,000 per month. Patient Assistance Programs:
- Wegovy®/Ozempic® (Novo Nordisk): If you have insurance that covers these medications, copay cards can significantly reduce your costs. Research Novo Nordisk's savings program for details.
- Zepbound®/Mounjaro® (Eli Lilly): Similar assistance programs are available through Eli Lilly Connect.
- Alternative FDA-Approved Weight Loss Medications: If GLP-1 medications are now out of reach financially, consider these alternatives:
- Saxenda (liraglutide): Saxenda is an injectable GLP-1 agonist FDA-approved specifically for weight loss. It works by mimicking a hormone that targets areas of the brain that regulates appetite and satiety (fullness), this can help with your overall portion control and ultimately weight loss. Unlike weekly GLP-1 injections, Saxenda requires daily administration.
- Other Weight Loss Prescription Options:
- Qsymia (phentermine-topiramate): A combination medication that suppresses appetite and increases feelings of fullness
- Contrave: Works on brain pathways involved in hunger and cravings
- Weight Loss Surgery Options
- For those with significant obesity or weight-related health conditions, bariatric surgery might be a more viable solution:
- Gastric Sleeve: Removes approximately 80% of the stomach
- Gastric Bypass: Creates a small stomach pouch and reroutes the digestive tract
4. Nutritional Support and Meal Plans
At New Jersey Bariatric Center®, our registered dietitians provide personalized nutritional counseling and custom meal planning to help combat weight regain during your transition from GLP-1 medications. As you adjust to this change, our nutrition experts can guide you with tips to maintain the progress you've achieved while using weight loss medications.
What If You Regain Weight After Compound Medications End?
RELATED: Will I Regain Weight After StoppingPrescription Weight Loss Medications?
A common concern when stopping GLP-1 medications is potential weight gain. Research suggests that without continued treatment or lifestyle modifications, some weight gain is likely. An NIH study concluded that patients may regain approximately 2/3 of their lost weight within a year of stopping GLP-1 medications.
This underscores the importance of working with a qualified weight loss doctor to develop sustainable strategies beyond medication. The weight loss team at NJBC provides a comprehensive approach to patients transitioning from compound weight loss medications.
From regular monitoring and support, personalized nutrition plans, lifestyle modification techniques and exercise programs, we are here for you.
Our commitment is to support patients through this transition. Questions? Call 908-481-1270 or click here to schedule an appointment.
FAQs About the FDA Compounding Ban
While some compounding pharmacies might attempt to continue offering modified formulations, the FDA's directive is clear. Patients should transition to FDA-approved alternatives under medical supervision.
Coverage varies significantly by insurance provider and specific plan. Many insurers require prior authorization documenting medical necessity. Consult your insurance provider to confirm weight loss medication coverage. Call NJBC for questions about what to ask your insurance provider.
The FDA has expressed concerns about compounded versions, noting they "received multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors associated with compounded injectable semaglutide products." However, many patients used compounded versions successfully under proper medical supervision.
