For many patients seeking effective weight loss solutions, compounded semaglutide has been an accessible and affordable alternative to FDA-approved medications like Ozempic® and Wegovy®. However, a major FDA decision is set to take effect: as of April 22, 2025, compounding pharmacies will no longer be allowed to produce compounded semaglutide.
This change comes as the FDA has officially removed semaglutide from its drug shortage list, signaling that supply levels of the brand-name versions are now stable. As a result, compounded versions will no longer be legally permitted under federal regulations.
With this shift, many patients currently using compounded semaglutide are left wondering what their next steps should be. What alternatives exist? Will compounded semaglutide ever return? And how can patients continue their weight loss journey without disruption?
In this article, we’ll explore the impact of this FDA decision, discuss available treatment options—including FDA-approved medications and lifestyle-based strategies—and help you navigate the transition effectively.
Contents
Overview of Semaglutide and Its Popularity
What Is Semaglutide?
Semaglutide is a GLP-1 receptor agonist, a type of medication that mimics a hormone in the body called glucagon-like peptide-1 (GLP-1). This hormone helps regulate blood sugar levels, slow digestion, and reduce appetite—making it highly effective for both diabetes management and weight loss.
Originally developed as a treatment for type 2 diabetes, semaglutide was first approved under the brand name Ozempic®. Due to its significant weight loss benefits, a higher-dose version was later introduced as Wegovy®, specifically for weight management in individuals with obesity or overweight conditions.
Why Has Compounded Semaglutide Been So Popular?
Despite the availability of Ozempic® and Wegovy®, compounded semaglutide quickly became a sought-after alternative. Several key factors contributed to its popularity:
- Cost Savings: Brand-name semaglutide medications can be expensive, especially for patients without insurance coverage or with high out-of-pocket costs. Compounded versions were often available at a lower price.
- Supply Shortages: High demand for Ozempic® and Wegovy® led to persistent shortages, making it difficult for patients to obtain their prescriptions. Compounded versions provided an alternative when brand-name medications were unavailable.
- Customization: Compounded versions could be tailored to specific needs, such as modified dosing or alternative formulations.
However, with the FDA’s latest decision, compounded semaglutide will soon be off the market, and patients will need to explore other options.
FDA Decision and Its Implications
Details on the FDA Ruling
On February 21, 2025, the FDA announced that semaglutide has been removed from its drug shortage list after determining that supply levels of Ozempic® and Wegovy® are now stable. As a result, compounding pharmacies will no longer be legally permitted to manufacture compounded versions of semaglutide after April 22, 2025.
This ruling aligns with the FDA’s long-standing policy that compounded drugs cannot be made if a commercially available version is not in shortage. Compounded semaglutide had been allowed under a regulatory exception due to previous supply chain disruptions, but this exception no longer applies.
Novo Nordisk, the manufacturer of Ozempic and Wegovy, petitioned the FDA to remove semaglutide from the shortage list, arguing that production and supply levels had sufficiently stabilized. The FDA ruled in favor of Novo Nordisk, stating that the company had demonstrated adequate availability of its brand-name products to meet patient demand. As a result, compounded semaglutide is no longer permitted under federal regulations.
Timeline and Next Steps
- February 21, 2025: The FDA officially removes semaglutide from the drug shortage list.
- April 22, 2025: The grace period for compounding pharmacies ends. After this date, compounded semaglutide will no longer be legally available.
- Beyond April 2025: Patients who have been using compounded semaglutide will need to transition to other treatment options, such as Ozempic®, Wegovy®, or alternative weight loss treatments.
Long-Term Outlook: Will Compounded Semaglutide Return?
At this time, it doesn’t look likely that compounded semaglutide will return to the market. Unless another supply shortage occurs and the FDA reinstates it on the drug shortage list, compounding pharmacies will not be permitted to produce it.
With that said, there is currently an ongoing court case challenging aspects of this decision. One of the key arguments in the case is whether or not pharmaceutical companies like Novo Nordisk should be the sole provider of information on shortages of their own medications. Currently, the FDA relies on manufacturers to report supply levels, which raises concerns about transparency and whether financial incentives might influence these reports.
Possible Outcomes of the Court Case:
- If the court rules in favor of increased oversight, the FDA may be required to consider additional data sources beyond manufacturer reports when determining drug shortages. This could potentially lead to semaglutide being placed back on the shortage list if an independent review finds that supply is still constrained. However, this process will take time.
- If the court upholds the current process, pharmaceutical companies will remain the primary source of information on drug shortages, making it less likely that compounded semaglutide will be reinstated unless Novo Nordisk reports a renewed supply issue. Unfortunately, Novo Nordisk is unlikely to do this.
- If new legislation or FDA policy changes emerge from the case, broader reforms could be implemented, affecting how shortages are determined and how compounding exemptions are granted in the future. But this could take years to occur.
While the outcome remains uncertain, patients who have relied on compounded semaglutide should plan for alternative long-term solutions, as a return to compounding remains very unlikely under current regulations.
This development will surely be a bump in the road for many patients. But there’s plenty of room for optimism. The landscape of weight loss medications is evolving rapidly. New GLP-1 receptor agonists and other pharmaceutical treatments are currently in development, which could provide additional options for patients in the future. And the science of obesity and weight management in general continues to advance, showing promise for new types of treatment options.
Other Potential Prescription Alternatives
With compounded semaglutide no longer an option, many patients may wonder if other prescription treatments could serve as effective alternatives. While Ozempic® and Wegovy® remain the most well-known semaglutide-based options, there are several other medications that can aid in weight management.
Other GLP-1 Receptor Agonists
If you’re looking for a medication with similar mechanisms to semaglutide, you may want to consider other GLP-1 receptor agonists. These drugs work by mimicking the body’s natural GLP-1 hormone to reduce appetite and improve blood sugar control. Options include:
- Tirzepatide (Mounjaro®, Zepbound®): Tirzepatide is a dual GIP/GLP-1 receptor agonist, meaning it affects two appetite-regulating hormones instead of just one. Studies have shown that it may lead to even greater weight loss than semaglutide. Unfortunately, for the same reasons that compounded semaglutide can no longer be manufactured, there is no compounded version of tirzepatide.
- Liraglutide (Saxenda®, Victoza®): Liraglutide was an earlier GLP-1 receptor agonist approved for weight management under the brand name Saxenda®. While effective, it requires daily injections compared to semaglutide’s once-weekly dosing.
- Dulaglutide (Trulicity®): Another diabetes medication in the GLP-1 family, Trulicity has been used off-label for weight loss but is generally less potent than semaglutide.
While these medications do not combine GIP and GLP-1 activity like tirzepatide, they remain a strong choice for many patients seeking help with weight loss and metabolic control.
Zepbound® Savings Program
On February 25, 2025, Eli Lilly announced the expansion of its Zepbound® savings program, offering additional vial dose options and new cost-saving opportunities for self-pay patients. These updates aim to improve affordability and access for those paying out of pocket.
Non-GLP-1 Medications
For those who may not tolerate GLP-1 receptor agonists or are looking for different approaches, there are other FDA-approved weight loss medications to consider:
- Phentermine-Topiramate (Qsymia®): A combination medication that helps suppress appetite and increase energy expenditure.
- Naltrexone-Bupropion (Contrave®): Works on the brain’s reward system to reduce food cravings and control hunger.
- Orlistat (Alli®, Xenical®): A fat-blocking medication that prevents the absorption of some dietary fats.
Reconsidering Past Medications
It’s important to recognize that the body’s response to medications can change over time. At OVYVO, we take an individualized approach, and we don’t rule out a medication simply because it wasn’t the right fit in the past. For example, a patient who previously experienced side effects on one medication then switched to another may find that the previous medication is more tolerable under different circumstances or with modified dosing strategies.
Additionally, there are many well-established weight loss medications that have been on the market for decades and remain viable solutions when carefully matched to a patient’s current health status and needs. These time-tested therapies can still play a key role in a personalized, comprehensive weight loss plan. If you’ve tried certain medications before without success, it may be worth revisiting them with your provider to explore whether they could now be a better fit.
Considering Brand-Name Semaglutide: Ozempic® and Wegovy®
With compounded semaglutide no longer available, Ozempic® and Wegovy® remain the only FDA-approved semaglutide-based medications. While some patients initially turned to compounded versions due to cost or supply concerns, brand-name options offer a safe and effective solution for those seeking continued weight loss support.
Why Consider Ozempic® or Wegovy®?
Both Ozempic® and Wegovy® contain semaglutide, the same active ingredient as compounded versions. They offer:
- Proven Effectiveness: Clinical trials show that Wegovy® can lead to an average weight loss of 15% or more of body weight when combined with diet and exercise. Ozempic®, while officially approved for diabetes, has also demonstrated significant weight loss benefits in off-label use.
- FDA Oversight and Safety: Unlike compounded versions, which lacked FDA regulation, Ozempic® and Wegovy® are manufactured under strict quality control to ensure safety, consistency, and effectiveness.
Possible Downsides
Despite their benefits, Ozempic® and Wegovy® may present challenges for some patients, including:
- Cost and Insurance Coverage: Without insurance, these medications can be expensive. However, manufacturer savings programs and patient assistance options may help reduce costs.
- Potential Side Effects: Like all GLP-1 medications, Ozempic® and Wegovy® can cause nausea, vomiting, diarrhea, and other gastrointestinal issues, especially when starting treatment or adjusting doses.
- Availability Issues: While the FDA has declared that the shortage is over, sporadic supply issues may still occur in certain areas due to high demand.
If you’re currently using compounded semaglutide and need to transition to a brand-name alternative, talk to your OVYVO provider about the best way to switch. We can help guide you through dosing adjustments, cost-saving options, and strategies for managing side effects to ensure a smooth transition.
Wegovy® Discount Program
On March 5, 2025, Novo Nordisk introduced the NovoCare® Pharmacy, offering all doses of FDA-approved Wegovy® for $499 per month for cash-paying patients. This program also provides the convenience of home delivery, making access easier for those who qualify.
NovoCare® Pharmacy may be an option for:
- Uninsured patients
- Commercially insured patients without Wegovy® coverage
Important Note: Patients enrolled in any government, state, or federally funded insurance program (such as Medicare or Medicaid) are not eligible for NovoCare® Pharmacy.
Understanding insurance coverage for weight loss medications can be challenging, but it’s always worth rechecking your benefits—especially if your coverage has changed due to a job switch, adding or removing dependents, or transitioning to a spouse’s plan. Most insurance providers allow for changes annually, typically (but not always) on January 1st, making each renewal period an opportunity to explore new options for coverage.
If you haven’t checked your insurance plan recently, now is a good time to do so. Insurance coverage for weight loss medications varies widely depending on your employer and plan structure. For example, Pennsylvania Medicaid covers weight loss medications, and federal employees also typically have access to coverage. However, state employees in Pennsylvania do not currently have this benefit.
Additionally, recent FDA approvals have introduced new indications for some of these medications, which may open up additional coverage opportunities:
- Wegovy® for Cardiovascular Event Risk Reduction: Approved on March 8, 2024, for patients with established cardiovascular disease who are also overweight or obese. This means insurance providers may now cover Wegovy® for individuals who qualify under this diagnosis.
- Zepbound® for Sleep Apnea: Approved on December 20, 2024, for individuals with obstructive sleep apnea. Patients who were previously denied coverage for Zepbound® may now have access if they have a qualifying diagnosis.
Given that two new indications were approved in the past year, it’s likely that more approvals will follow. Manufacturers continue to conduct studies on these medications, and each new FDA approval allows for an extension of the drug’s patent, incentivizing further research and expanded indications. Staying informed about these developments can help you take advantage of new opportunities for insurance coverage.
At OVYVO, we work closely with patients to evaluate all available insurance and pharmacy discount options. If you need help determining your eligibility or navigating coverage changes, our team is here to assist you.
Lifestyle and Support-Based Alternatives
While medications like Ozempic® and Wegovy® can be powerful tools for weight loss, lasting success is about more than just prescriptions. Incorporating sustainable lifestyle changes and a comprehensive, supportive approach can help you maximize results and maintain progress long-term. Key lifestyle modifications include:
- Nutrition-Focused Eating: Emphasizing lean proteins, fiber-rich vegetables, and healthy fats can help you feel full longer and support overall health.
- Regular Physical Activity: Engaging in both strength training and cardiovascular exercise helps maintain muscle mass, boost metabolism, and improve overall well-being.
- Mindful Eating: Practicing portion control, slowing down during meals, and recognizing hunger cues can prevent overeating and support long-term success.
- Stress and Sleep Management: Chronic stress and poor sleep can increase cravings and hinder weight loss, making relaxation techniques and sleep hygiene critical components of a healthy routine.
OVYVO’s Integrative Approach to Weight Loss
At OVYVO, we take a holistic, patient-centered approach to weight loss, recognizing that lasting success requires more than just a prescription. Unlike many weight loss programs that simply prescribe one or two medications and send patients on their way, we evaluate the full picture—considering medications, metabolic health, lifestyle factors, and underlying conditions that may be affecting weight loss.
Our experienced team goes beyond standard prescriptions, identifying potential barriers to progress and tailoring solutions to each individual. Whether you need help navigating medication options, adjusting your current regimen, or exploring non-medication-based strategies, we’re here to help you find the right path.
- Personalized Treatment Strategies: We provide a full range of weight loss solutions, from prescribing FDA-approved medications individually to combining therapies for maximum effectiveness. But we also recognize that medications aren’t the only tool—we work with patients on nutritional counseling, metabolic health optimization, and lifestyle strategies for long-term success.
- Flexible Prescribing Options: Whether you need assistance with manufacturer discount programs, insurance coverage, or choosing the right pharmacy, we ensure that your treatment plan is both affordable and accessible.
- Expertise That Goes Beyond Medications: With more than 11 years in practice focused on medical weight loss, our team has been helping patients succeed long before compounded medications became available. We know that effective solutions existed before these newer treatments—and they will continue to evolve as the landscape changes.
- A Science-Backed, Whole-Body Approach: We operate under the guidance of Dr. Baughman, Board Certified in Obesity Medicine, ensuring that every patient’s plan is based on the latest research and best clinical practices. In addition to weight loss medications, we evaluate hormonal imbalances, metabolic conditions, and other factors that may be influencing your weight loss progress.
At OVYVO, we don’t believe in one-size-fits-all solutions. Whether you’re looking for guidance on medications, a fresh approach to weight loss, or support in making sustainable lifestyle changes, our team is here to help you succeed.
Last Chance to Order a 90-Day Supply of Compounded Semaglutide – Deadline: April 11
Time is running out! Through Friday, April 11, 2025, our patients can still order 30-, 60-, or 90-day supplies of compounded semaglutide before production ceases. This final opportunity allows you to:
We accept HSA/FSA payments and recommend using a CareCredit account, which offers 0% interest if paid in full within the designated term (typically 6, 12, or 18 months).
To place your order: Call us or discuss it at your next appointment. We’ll notify you when your order is ready for pickup.
Don’t wait—secure your final supply before it’s too late…
Final Thoughts
The end of compounded semaglutide marks a significant shift for many patients who have relied on it as an affordable and accessible weight loss solution. However, this change does not mean that your weight loss journey has to stop. FDA-approved alternatives like Ozempic® and Wegovy®, as well as other prescription medications and lifestyle-based approaches, provide multiple pathways to continued success.
At OVYVO, we understand that navigating these changes can be overwhelming. Our team is here to help you:
- Evaluate your medication options and determine the best alternative for your needs.
- Navigate insurance coverage and financial assistance to make treatment more affordable.
- Develop a personalized weight loss strategy that includes nutrition, exercise, and lifestyle coaching.
If you are currently using compounded semaglutide, or if you were on tirzepatide and planned to transition to compounded semaglutide, we encourage you to schedule a consultation with your OVYVO provider as soon as possible. We’ll help you transition smoothly to a new treatment plan that keeps you on track toward your weight loss goals.
Disclaimer: This content is for informational purposes only and is not intended as medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before making any changes to your diet or exercise program.
Disclaimer: Compounded semaglutide is prepared by a licensed compounding pharmacy for individual patients based on a valid prescription. Compounded preparations are tailored to meet the unique needs of patients when FDA-approved, commercially available medications do not suit their specific requirements or when there is a shortage of these medications. OVYVO Medical Weight Loss distributes compounded semaglutide in accordance with state and federal regulations. Details about the pharmacy and the compounding process are available upon request. While semaglutide is an FDA-approved active ingredient in certain commercially available medications for managing specific conditions, compounded semaglutide is not reviewed or approved by the Food and Drug Administration (FDA) for safety or efficacy. We make no claims regarding the safety or effectiveness of compounded semaglutide for any particular condition. The safety and quality of compounded medications are regulated by state boards of pharmacy and other relevant authorities.
In compliance with the FDA’s recent decision to remove semaglutide from the drug shortage list, OVYVO Medical Weight Loss patients may purchase compounded semaglutide up through and no later than Friday, April 11, 2025. All prescriptions must be picked up by Tuesday, April 22, 2025, before 6:00 PM. After this date, OVYVO will no longer be able to prescribe or distribute compounded semaglutide.