Dive into must-know information about compounded GLP-1s to understand how they can support cost containment while offering access to the medications your employees may need.
GLP-1s continue revolutionizing how we think about treating diseases beyond just obesity; however, shortages remain a concern for many patients and providers. This has given rise to compounding pharmacies, which have faced significant social and scientific commentary over their legitimacy.
In reality, compounded GLP-1s create a new path to cost containment for employers while providing their population with access to medications, even in the midst of a shortage, at a lower out-of-pocket cost. Below, we dive into what employers need to know about compounded GLP-1 medications, including how they can drive value for their benefits strategy.
Throughout 2021 and 2022, public awareness of the potential weight-loss benefits of prescription GLP-1 agonists such as Ozempic®, Wegovy®, and Mounjaro®, among others, began to skyrocket.
A massive spike in demand for these medications followed. Estimates suggest that the number of semaglutide prescription fills alone increased by 442% between January 2021 and December 2023, going from 471,876 to 2,555,308.
This demand for GLP-1s, specifically semaglutide injections, likely contributed in large part to the Food and Drug Administration (FDA)’s reported shortage of both Ozempic® and Wegovy®, which was first issued in March 2022.
As of December 2024, semaglutide injections remained in shortage. All doses of Wegovy and Ozempic are listed as “available,” but semaglutide injections have yet to be officially removed from the shortage list. Tirzepatide, on the other hand, was removed on December 19, 2024.
A compounded medicine is a medication that’s custom-made for a patient by a compounding pharmacy. In the case of compounded semaglutide, the medicine contains the same active ingredient that is found in FDA-approved medications, such as Ozempic®, Wegovy®, or Rybelsus®.
In other words, a compounded medication is not the same thing as a brand-name medication. It’s also not a “generic” version of a branded medication. Instead, as described by the FDA, compounded drugs are created for patients who cannot be appropriately treated with an FDA-approved medication. For example, a pharmacy may create compounded analgesic topicals for a patient with chronic pain, whose symptoms cannot be adequately treated by an FDA-approved medication. In this case, the topical’s potency and active ingredients may be changed from what’s found in an FDA-approved medication to better suit the patient’s health needs.
Compounding pharmacies and medications are nothing new to health care nor obesity management. Typically, compounding pharmacies are not allowed to compound medicines that are direct copies of an FDA-approved medication, such as Ozempic®.
However, when the FDA places a branded medication on its shortage list, compounding pharmacies may compound medicines that have the same active ingredients. “Compounding pharmacies are authorized by federal law and follow FDA Guidance for Industry in preparing copies of FDA-approved drugs when that drug is listed as ‘currently in shortage’ on the FDA’s drug shortage list,” explained Scott Bruner, CEO of the Alliance for Pharmacy Compounding, in a 2024 statement.
This is only true, though, if a pharmacy meets certain requirements, including:
• Using the same form of semaglutide that’s used in FDA-approved medications (known as semaglutide base).
• Purchasing semaglutide base from FDA-registered facilities.
• Compounding semaglutide following all state and federal regulations.
• Dispensing compounded semaglutide with a prescription from a licensed healthcare professional.
No, compounded GLP-1s are not FDA-approved or evaluated by the FDA for safety or efficacy. However, traditional compounding pharmacies are regulated under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) and by their state boards of pharmacy. They may also be accredited or certified for non-sterile or sterile compounding services. The FDA does not inspect or approve them. Still, state and federal authorities can issue warning letters and injunctions, seize products, or otherwise prosecute compounding pharmacies for violating the FDCA or state laws and regulations, as warranted.
Likewise, under the 2013 Drug Quality and Security Act (DQSA), all 503B outsourcing facilities – another type of compounding pharmacy – must register with the FDA. They’re also required to follow good manufacturing processes, though they are not required to compound pursuant to a patient-specific prescription. That means these outsourcing facilities can create large quantities of compounded medications, including GLP-1s.
In this way, compounding can support better access to medications at scale. It also gives patients the opportunity to access medications made without inactive ingredients or components that could cause them harm.
These benefits remind us that the goal of compounding is not to replace brand name drugs but to open new doors for increasing access to therapeutics for eligible patients. Compounding also ensures that patients and their physicians have consistent access to the treatments and medications they rely on, even when drug shortages emerge.
So, if many compounded GLP-1s have been legally produced by approved outsourcing facilities to help patients access medication during the semaglutide shortage, why have they been subject to so much controversy?
Some of the issues have been inappropriate dosing of compounded GLP-1s and dosing errors. The latter has been a result of patients mistakenly drawing up more of the medication than what was prescribed to them likely because patients are receiving prescriptions from sources that lack adequate patient education and training in obesity medicine.
It’s important to note that this risk isn’t due to the products being compounded but instead due to the rise in counterfeit versions of GLP-1s, specifically counterfeit semaglutide injections.
These counterfeits are not sold by compounders that follow FDA guidance and regulations laid out under Section 503B of the FD&C Act. How can we be sure? Because they do not use the same form of semaglutide – semaglutide base – as name-brand medications like Ozempic®.
Instead, many counterfeits use salt forms, including semaglutide sodium and semaglutide acetate, of active ingredients. These illegally-marketed versions of FDA-approved drugs may claim to be authentic, but they may contain the wrong ingredients or contain too little, too much, or no active ingredient at all.
In the age of GLP-1s, many employers have had to make difficult decisions regarding formulary coverage. Because cost-containment is critical for organizations providing coverage for the branded versions of these medications (or considering doing so), compounded medications can offer an alternate option to strategies like preferred network status, step therapy, or prior authorizations.
Providing access to a metabolic care clinic with compounded GLP-1s as part of their broad medication toolkit can help medically eligible patients experience benefits similar to those of traditional GLP-1s at a much lower out-of-pocket cost.
Found members have experienced results that indicate that compounded medications can support weight loss goals in alignment with name-brand GLP-1s. Members reported a 5% weight loss rate after three months with compounded GLP-1s compared to a 5.6% weight loss rate with branded GLP-1s.
The lower cost of these compounded medications can either be passed on to employees or covered by employers.
Since this type of medication is not covered by insurance, the out-of-pocket cost can be passed to employees, eliminating the potential impact GLP-1 coverage could have on an employer’s pharmacy budget. On the other hand, covering the cost – either partially or in full – as an employer can be leveraged as a tool for talent attraction and retention, as it signals to employees that an organization is committed to increasing access to specialized care.
GLP-1 medications are associated with a high price tag, potentially costing upwards of $1K+ per employee per month. Compounded GLP-1s prescribed by Found-affiliated providers, however, cost only $189 per month, representing a more cost-effective option for employers and their members.
Data from the National Alliance of Healthcare Purchaser Coalitions revealed that providing GLP-1 coverage for a single employee can average $7k- $10K for the year, and a family of dependents can represent an additional $25K in annual spending–on top of the $10K per employee of GLP-1 coverage.
Compounded GLP-1s offer a new path to lowering these medication costs. By partnering with Found, organizations can provide employees with access to metabolic care that leverages a broad medication toolkit. Plus, care is personalized to every member based on their unique biology. Found’s Care Team leverages a proprietary metabolic health assessment, MetabolicPrintTM, to ensure medically eligible members are prescribed the right therapy from our toolkit instead of using GLP-1s, branded or compounded, as the first line of treatment for everyone.
See MetabolicPrint in action through our hands-on virtual experience here.
Found is one of the largest telehealth weight care providers in the U.S., having conducted over 1M clinical consults. Our mission is to help employers ignite a culture of employee wellness that prioritizes metabolic health by providing access to personalized care that transforms how obesity and diabetes are treated and managed.
Ozempic®, Rybelsus®, and Mounjaro® are only FDA-approved to treat type 2 diabetes. Found is not affiliated with Eli Lilly and Co., the owner of the registered trademark Mounjaro®, nor is it affiliated with Novo Nordisk A/S., the owner of the registered trademark Ozempic®, Wegovy®, and Rybelsus®.
Scannel, C., Romley, J., Myerson, R., Goldman, D., & Qato, D.M. (2024, August 2). Prescription Fills for Semaglutide Products by Payment Method. JAMA Health Forum, 5(8), e242026. https://doi.org/10.1001/jamahealthforum.2024.2026.
U.S. Food and Drug Administration (FDA). (2024, November 1). FDA Drug Shortages: Semaglutide Injection. Retrieved February 3, 2025, from https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Semaglutide%20Injection&st=c
U.S. Food and Drug Administration (FDA). (2024, December 19). Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products (Mounjounaro and Zepbound). PDF. Retrieved February 3, 2025, from https://www.fda.gov/media/184606/download?attachment
U.S. Food and Drug Administration (FDA). (2024, November 15). Compounding and the FDA: Questions and Answers. Retrieved February 3, 2025, from https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
Alliance for Pharmacy Compounding. (2024, March 11). Statement on rules governing compounding, what FDA guidance says about permissibility of compounding “essentially a copy” of an FDA-approved drug – and what those have to do with GLP-1s.(n.d.) Retrieved January 26, 2025 from https://a4pc.org/files/APC-Compounded-GLP-1s-Media-Brief-REVISED-March-2024.pdf
Mattingly, T.J., & Conti, R.M. (2025, January 17). Marketing and Safety Concerns for Compounded GLP-1 Receptor Agonists. JAMA Health Forum, 6(1), e245015. https://doi.org/10.1001/jamahealthforum.2024.5015.
U.S. Food and Drug Administration (FDA). (2024, December 18). FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. Retrieved February 3, 2025, from https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
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