Over the last few years, compounded GLP-1 and GLP-1/GIPs that claim to contain semaglutide and tirzepatide have become popular alternatives to FDA-approved medications for patients on their weight loss journey. The rise in compounded weight loss medications was made possible because FDA-approved medications like Wegovy® and Zepbound® were on the FDA shortage list, allowing compounded pharmacies to manufacture medications to help fill the supply chain void. However, both of these medications were recently removed from the shortage list, limiting the ability for compounding pharmacies to continue producing them. As a result, patients who were previously taking compounded medications may no longer be able to access them.
This article explores key differences between compounded and FDA-approved medications, details the safety and efficacy concerns, outlines the changing environment, and provides practical steps for a smooth switch. Understanding these changes will help patients make informed decisions and maintain continuity of care.
What are compounded medications?
Compounded medications are custom-made drugs prepared by pharmacists to meet specific patient needs when commercially available options are unsuitable or unavailable. These formulations may involve a different form of delivery (e.g. liquid for a patient who can’t swallow pills), different dosages, removing allergens, or combining ingredients in unique ways. Compounded GLP-1 and GLP-1/GIP receptor agonists have been made commercially available and used as an alternative to brand-name FDA-approved weight loss medications because there have been supply shortages of FDA-approved medications. The availability of lower-cost compounded medications has increased accessibility to patients who may not have been able to afford the more expensive FDA-approved medications. However, compounded weight loss medications are not FDA-approved or regulated like their FDA-approved counterparts which raises significant concerns regarding their safety and efficacy. Compounded “semaglutide” and “tirzepatide” claim to contain the same active ingredients as their brand name FDA-approved counterparts; however manufacturers of both Wegovy and Zepbound caution consumers that this is not always the case.
Differences between compounded and FDA-approved GLP-1s
There are several key differences in safety, regulation, cost, and effectiveness between compounded and FDA-approved medications that are important to understand.
One of the biggest distinctions is FDA approval and regulation. FDA-approved GLP-1 and GLP-1/GIP medications, such as Wegovy, Zepbound, Mounjaro®, and Ozempic®, undergo extensive clinical trials to ensure they are safe, effective, and consistently manufactured. They are produced by pharmaceutical companies under strict quality control measures. In contrast, compounded GLP-1s are not FDA-approved. They are mixed or altered by compounding pharmacies (503A and 503B), using different formulations or ingredients. Since these medications do not go through the same rigorous testing, their safety and efficacy is unknown.
The dosing and formulation of these compounded medications typically vary depending on how they are produced. Unfortunately, due to the variability in dosing and, in some cases, minimal medical oversight, dosing errors have lead to serious adverse health outcomes. There is also the question of whether these compounded medications have the same bioavailability as their FDA-approved counterparts or even if they are effective at all. Injectable weight loss medications are administered as injections due to the difficulty with absorption when taken in an oral form.
Another major difference is cost and insurance coverage. FDA-approved GLP-1 medications can be expensive for patients paying out of pocket if they are not covered by insurance. Some manufacturers offer savings programs or patient assistance options. Eli Lilly and Novo Nordisk, the manufacturers of Zepbound and Wegovy, respectively, have launched programs where patients can take these medications (with a prescription from a licensed medical clinician) at a reduced out-of-pocket cost (LillyDirect® Pharmacy and Novocare® Pharmacy). While compounded GLP-1 medications may be a lower-cost alternative, they are rarely covered by insurance, requiring patients to pay out of pocket.
Among compounding pharmacies, there can be significant variability in terms of the same level of oversight or quality control. Many patients obtain compounded GLP-1s through online pharmacies or medspas, where there is a higher risk of contamination, inconsistent dosing, and little medical oversight to monitor side effects or adverse reactions. Without proper regulation and quality measures, sources of compounded medications may pose significant health and safety risks. Compounded GLP-1 medications have been linked to hospitalizations and death in some instances.
Ultimately, while compounded GLP-1s may be more affordable compared to the FDA-approved versions, they come with higher risks as described. That is why leading obesity societies such as the OMA, TOS and OAC recommend against compounded weight loss medications and clinicians at Form Health do not prescribe compounded weight loss medications.
Benefits of FDA-approved medications
When it comes to safety and effectiveness, FDA-approved GLP-1 and GLP-1/GIP medications are the best choice. These drugs have undergone rigorous clinical trials to demonstrate their efficacy for weight loss while also ensuring that potential risks and side effects are well understood. This level of testing and oversight does not exist for compounded versions. Consistency and quality control are other major advantages of FDA-approved medications. Each dose of an FDA-approved GLP-1 and GLP-1/GIP medication is manufactured under strict conditions, ensuring that you receive the same potency and effectiveness every time. FDA-approved medications also include a batch number that can be traced to a production facility for quality control.
Compounded drugs, on the other hand, are mixed by individual pharmacies, which can lead to variations in quality, dosing, and a lack of quality control. Some compounded versions claiming to contain semaglutide actually contain semaglutide salts (like semaglutide sodium), which have not been studied in humans, meaning their effectiveness and safety are unknown.
Another benefit of FDA-approved GLP-1 and GLP-1/GIPs is well-documented safety profiles. Because they have been tested extensively, doctors and patients know what to expect in terms of side effects, proper dosages, and interactions with other medications. Compounded versions have not been tested and therefore lack this level of transparency making it harder to predict their effects or potential risks.
Finally, FDA-approved GLP-1 and GLP-1/GIPs may be covered by insurance and some manufacturers also offer savings programs, rebates, or patient assistance to help reduce costs. While compounded versions may have a lower out of pocket cost, there are inherent risks with using them that may lead to greater costs down the road if, for example, they lead to hospitalization or emergency room visits.
The legislative landscape of compounded drugs
The regulation of compounded drugs is an evolving process, and important concerns have been raised related to medication safety, availability, and cost. The popularity and demand for effective weight loss treatments has surged leading to prolonged and widespread shortages thereby opening the door for compounded medications to fill this gap. Additionally, given the limited insurance coverage and cost of FDA-approved GLP-1s and GLP-1/GIPs, out of pocket costs may push individuals to pursue a less expensive and potentially riskier alternative in compounded weight loss medications.
Overview of current regulations
Compounded drugs have historically been regulated under the Federal Food, Drug, and Cosmetic Act (FDCA), which distinguishes between traditional compounding pharmacies (503A) and larger outsourcing facilities (503B).
Compounding pharmacies have been able to produce versions of medications when a drug is in shortage or when they are compounded for individual patients with specific needs. However, concerns about safety, inconsistent formulations, and the use of unapproved ingredients (such as semaglutide salts) have raised concerns.
Recent changes affecting compounding
Changes affecting GLP-1 and GLP-1/GIPcompounding differ slightly between tirzepatide and semaglutide. In October 2024, tirzepatide was removed from the FDA’s medication shortage list, preventing 503A and 503B compounding pharmacies from continuing production. The dates set to stop production of compounded tirzepatide were February 18th for 503A pharmacies, and March 19th for 503Bs; however this was not to be enforced until a final decision was made by the court. Despite some pushback from compounders, the FDA stood their ground on this decision which was confirmed in March 2025, when a court judge sided with the FDA to require that compounding pharmacies stop production on the basis that tirzepatide is no longer experiencing a shortage. As this decision was made after the deadline for 503A compounding pharmacies, they were to halt production once the decision was final and 503Bs were given until March 19th to end the production of compounded tirzepatide.
In February 2025, semaglutide was removed from the FDA’s medication shortage list and deadlines to halt compounding production were immediately set in place: 503A pharmacies must stop production by April 22, 2025 and 503B pharmacies must stop production by May 22, 2025. In a similar case to tirzepatide, the same compounding group has filed a lawsuit against the FDA to prevent this stop to semaglutide production, and the FDA will not enforce these deadlines until a judge has ruled over this decision.
Note that while large scale compounding of these anti-obesity medications are in the process of being stopped; technically 503A compounding pharmacies could continue to compound these medications so long as the medication is being modified according to certain conditions. For example, if the prescription contains a significant modification such as an alternative formulation due to an allergy, a significant change in dose or a different route of administration than the commercially available product.
Steps patients can take to switch smoothly
Patients who need to transition off of compounded GLP-1 and GLP-1/GIP medications may feel disappointed and overwhelmed, but the process can be smooth and manageable with careful planning and guidance. Here are some practical steps to help navigate the transition safely:
- Consult with an experienced healthcare clinician: Working with an obesity medicine specialist knowledgeable and experienced in their field ensures they are up-to-date with the latest science and information about FDA-approved weight loss medications. They will assess your medical history and current needs to determine the most suitable treatment plan for you going forward. There are multiple FDA-approved medications for weight loss, and based on a careful evaluation of your medical history and background the clinician may be able to recommend a good fit that is also much less expensive than out-of-pocket injectable medications.
- Create a transition plan: Collaborate with your healthcare clinician to develop a comprehensive transition plan that safely outlines the steps for stopping the compounded medication. This plan will clarify how you will switch to a new medication or whether you discontinue medication entirely. Regardless of your next step, collaborating with a medical expert to create a personalized plan ensures a safer transition for you.
- Implement lifestyle changes: Weight loss medications are to be used in combination with lifestyle changes such as nutrition, physical activity, and behavior changes to maximize the medication’s effectiveness. As you transition away from compounded GLP-1 or GLP-1/GIP medication, maintaining your lifestyle changes and/or implementing new ones can help prevent rapid weight regain. Healthcare providers like Registered Dietitians can help you develop a comprehensive weight loss and maintenance plan that includes lifestyle changes tailored to you.
- Monitor your health closely: As you begin to transition off a compounded GLP-1 or GLP-1/GIP medication, be aware of your physical and emotional well-being. It’s important to recognize any side effects and discuss them with your healthcare provider so they can tailor your treatment accordingly. Discuss how the transition is going and new strategies or treatments that could further support your weight goals moving forward. Regular follow-up appointments with a weight loss specialist are beneficial as they allow for ongoing support and any necessary adjustments to your treatment plan.
Working with Form Health for a seamless transition
Form Health weight loss experts can help you smoothly transition from a compounded GLP-1 or GLP-1/GIP medication to a comprehensive and science-based weight loss plan to achieve your weight loss and health goals. Our medical clinicians specialize in obesity medicine, providing personalized guidance on weight loss medications and only prescribe FDA-approved medications when appropriate. Your dedicated Care Team of a medical clinician and Registered Dietitian will create a personalized plan for you that addresses behavioral health, nutrition, physical activity, and may include a prescription for FDA-approved medication, if appropriate. With our expertise, you can be confident that you will have the expert support you need to achieve your goals safely.
To learn more about how Form Health can help you achieve your goals, sign up or send us a message today.
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