Navigating Compounded Semaglutide: What Health Care Providers Need to Know

ABSTRACT

Semaglutide, a glucagon-like peptide-1 receptor agonist, is FDA approved under the brand names Ozempic for treatment of type 2 diabetes and Wegovy for the treatment of overweight or obesity. The soaring popularity of these drugs, driven by social media and their overall efficacy, has resulted in nationwide shortages. The high costs associated with the FDA-approved products for both insurers and patients have also led to additional restrictions in access. In response to the unmet growing demand for semaglutide, suppliers have started to sell compounded versions of these products, both legally and illegally. This narrative review examines the implications of these compounded products on our health care system, highlighting concerns regarding their safety, efficacy, and regulatory status. Compounding, when done following federal and state regulations, can fill an important need in our health care marketplace. However, the compounded semaglutide products currently available to patients may lack the quality controls historically seen with compounded formulations, resulting in risks for dosing errors and adverse health outcomes. In addition, the compounded semaglutide market worldwide has seen batches of fraudulent products. Pharmacists and other health care providers have a unique opportunity to help guide patients in navigating this compounded semaglutide market, including directing them to lawful sources of compounded semaglutide, providing counseling on dosage and administration, and minimizing safety concerns.

Am J Manag Care. 2025;31(9):In Press

Takeaway Points

Managed care pharmacists and organizations can use this article to:

• Educate patients about risks associated with semaglutide obtained from nontraditional sources. If a patient requires the use of a compounded medication, aim to source the medication from a pharmacy accredited by the National Association of Boards of Pharmacy.
• Assess access to FDA-approved semaglutide products for patients with type 2 diabetes and focus on maintaining access by limiting off-label usage.
• Promote safe use by continuing to be vigilant in identifying patients who are obtaining compounded semaglutide and provide them with additional resources, including counseling on dosage and administration, to help minimize safety concerns.

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.1-3 In 2017, the FDA approved semaglutide under the brand name Ozempic for the improvement of glycemic control in adults with type 2 diabetes (T2D).1 In 2021, the FDA approved semaglutide under the brand name Wegovy for chronic weight management in adult patients with an initial body mass index of 30 or greater or of 27 or greater with at least 1 weight-related comorbid condition.2 (The Table provides a full list of semaglutide products, dosage forms and strengths, and indications.) Public interest in semaglutide increasedafter the discovery that it could result in weight loss.4 Celebrity influence and promotion on social media have contributed to its popularity, with individuals sharing their positive experiences and referring to it as a miracle drug.5

Besides favorable effects on weight management, semaglutide improves cardiometabolic risk factors and increases physical functioning with minimal adverse effects.6 In clinical trials, patients achieved a decrease in body weight of up to 16%.2 To maintain this weight loss, semaglutide needs to be taken continuously at a maintenance dose. However, these medications come with a significant price tag. The cost of Wegovy is more than $1600 per month and Ozempic costs more than $1100 per month.7

Product Supply Limitations and Impact

The intense public interest in semaglutide contributed to Wegovyshortages only months after its entrance into the market.5 Novo Nordisk, the manufacturer of Wegovy and Ozempic, stated in May 2024 that at least 25,000 new US patients were starting on Wegovy every week, approximately 4 times the number of new starts in December 2023. As a result of the high price tag, market pressures, and other factors, some insurers have excluded coverage of GLP-1 receptor agonists for the treatment of weight loss. This lack of insurance coverage, along with Wegovyshortages, has contributed to the off-label use of Ozempic for weight management.4 This off-label usage has led to market shortages of Ozempic, resulting in access issues for patients with T2D.5

Compounded Semaglutide and Regulatory Concerns

The inaccessibility and cost of semaglutide products are driving patients to search for an alternative supply, including more affordable compounded versions.8 Many compounding pharmacies, weight-loss clinics, and medical spas are selling compounded semaglutide products.9 Novo Nordisk confirmed it does not supply these providers with Wegovy and has received reports that some providers do not conduct a sufficient clinical evaluation before prescribing semaglutide-containing medicines.9 Generally, compounded versions of medications that are copies of FDA-approved medications are prohibited; however, this restriction is lifted when a medication is on the FDA drug shortages list, and both Wegovy and Ozempicwere on the drug shortages list until February 2025.10

Facilities that compound semaglutide are subject to oversight by both federal and state authorities.11 Compounded medications are not FDA approved but can be lawfully marketed by complying with either section 503A or 503B of the Federal Food, Drug, and Cosmetic Act.12 However, some sources may be marketing compounded semaglutide unlawfully, and these products may contain harmful ingredients or incorrect dosages.10 The FDA has issued multiple warning letters to online semaglutide suppliers that sold unapproved and/or misbranded drugs.13-17 Recipients of these letters are required to notify the FDA within 15 days regarding steps they have taken to address any violations and prevent their recurrence. Failure to do so may result in legal action such as seizure of property and injunction.13-17

The FDA has also published articles to inform patients and providers about compounded semaglutide, urging them to “obtain a prescription from their doctor, fill the prescription at a state-licensed pharmacy, and visit the BeSafeRx campaign for resources to safely buy prescription medications online.”10 Many organizations are taking action to spread awareness of compounded semaglutide and the potential for fake versions, including the World Health Organization (WHO), Novo Nordisk, news agencies, and health care experts.9,18-21 Unlawful semaglutide compounding extends beyond the US—the WHO issued an alert after detecting falsified batches of Ozempic in Brazil and the United Kingdom.18 The American Diabetes Association has also issued a guidance statement for providers and patients stating that “non–FDA-approved compounded incretin products are not recommended for use due to uncertainty about their content and resulting concerns about safety, quality, and effectiveness.”22 Even when compounded semaglutide is made lawfully, these products may have limited safety and efficacy.10,23

The objective of this narrative review is to provide a comprehensive overview of the current state of compounded semaglutide by searching published literature.

METHODS

A comprehensive PubMed search was conducted using the search terms (semaglutide OR Wegovy OR Rybelsus OR Ozempic) AND (fraud* OR misbrand* OR unapproved OR counterfeit OR unlawful OR compounded OR fake). The search was conducted from the database’s inception to October 1, 2024. Articles that contained reports of the following were included: (1) factors contributing to the semaglutide shortage, (2) details/extent of the use of compounded semaglutide, and (3) outcomes resulting from the use of compounded semaglutide.

RESULTS

The search yielded 13 results, 3 of which met inclusion criteria. The articles are discussed in more detail as follows.

“GLP-1 Agonists: A Review for Emergency Clinicians”

Due to the high cost of GLP-1 receptor agonists and the national shortage, this article24 notes that many patients with T2D have been nonadherent to their therapy or have resorted to using other sources to obtain the medication. The authors suggest that medication accessibility should be assessed when treating patients who are prescribed GLP-1 receptor agonists.

This article asserts that although some compounding pharmacies are legitimate and regulated by state boards, other compounded semaglutide suppliers are not regulated, including weight or wellness clinics and medical spas. These facilities often use a form of semaglutide derived from a salt, which is chemically different from the FDA-approved form that has been assessed for safety and efficacy. Additionally, this article discusses that some preparation processes have been found to involve nonsterile compounding conditions, including the presence of animal pet beds located near sterile compounding areas and the use of nonsterile toaster ovens for sterilization purposes.24

“UK Regulator Warns Public After Seizing Hundreds of Fake Ozempic Pens”

This article25 reported that between January 2023 and October 2023, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) seized 369 potentially fake Ozempic pens from online suppliers. The MHRA has advised the public to refrain from buying weight loss pens containing semaglutide or liraglutide without a prescription from online suppliers. The author emphasizes that not only is it illegal to sell these medications online without requiring a prescription but that buying from alternative suppliers increases the risk of receiving a product that does not match the ingredients on the label, which may lead to serious health risks.25

Health risks identified in the article include reports of individuals who have been hospitalized after using fraudulent Ozempic pens purchased online and reports of patients who experienced hypoglycemic shock and coma, suggesting the product may have contained insulin. The public was encouraged to report online sales of prefilled weight loss products to the MHRA so that the necessary action could be taken.25

“Administration Errors of Compounded Semaglutide Reported to a Poison Control Center—Case Series”

This article26 summarizes 3 cases of medication errors that were reported to the Utah Poison Control Center after administration of semaglutide obtained from compounding pharmacies and an aesthetic spa. The first patient experienced nausea and vomiting after self-administering 50 units of semaglutide instead of 5 units. The vial was not labeled with a concentration, and the medication was dosed in units and milliliters rather than milligrams. The second patient self-administered 1 mL of semaglutide instead of 0.1 mL and experienced vomiting, headache, weakness, and fatigue. The patient did not receive counseling on proper dosing or administration of the medication, which was dispensed in a vial with syringes. In both cases, the product was obtained from a compounding pharmacy and was coformulated with cyanocobalamin. The third patient experienced nausea, vomiting, and abdominal pain after receiving an injection of what was reported to be semaglutide from an aesthetic spa. It is unclear where the spa sourced the medication from and whether it was self-administered by the patient. The patient presented to the emergency department and was discharged the same day after receiving intravenous fluids and ondansetron.26

This article discusses the ways that compounded semaglutide can increase the risk of dosing errors, as it is often packaged in vials and lacks the safety features the prefilled pens provide. In addition, compounding pharmacies and aesthetic spas may not provide patients with the necessary counseling to properly self-administer an injection from a vial. As demonstrated in these cases, dosing errors can then lead to real-life complications and increased health care costs.26

DISCUSSION

The use of compounded semaglutide poses risks to patients and health care systems. Reasons individuals turn to using compounded semaglutide include shortages, lack of insurance coverage, and the high cost associated with the FDA-approved products.

The use of compounded semaglutide may lead to negative health consequences. The FDA has identified instances in which compounders have intentionally used incorrect ingredients in place of semaglutide, such as salt forms, which have not been studied to determine safety and efficacy.10 The FDA has additionally warned that unnecessary use of compounded drugs may expose patients to potentially serious health risks due to medication errors.27 Whereas Wegovy and Ozempic are prefilled pens, compounded semaglutide is packaged in vials and requires the patient to draw up the correct dose themselves, increasing the risk of dosing errors. Not only is this a patient safety concern, but there are also increased medical costs to manage these adverse events.

Because the increased demand for semaglutide has resulted in a shortage of Ozempic for patients with T2D, pharmacists should regularly assess adherence and accessibility of Ozempic for those patients. Moreover, managed care organizations should develop coverage criteria for T2D GLP-1 receptor agonists that incorporate evidence-based guidelines to ensure these medications are being reserved for the intended patient population.

We encourage pharmacists to educate patients about risks associated with semaglutide obtained from nontraditional sources. If a patient requires the use of a compounded medication, aim to source the medication from a pharmacy accredited by the National Association of Boards of Pharmacy (NABP), which demonstrates the pharmacy’s compliance with United States Pharmacopeia chapters 795, 797, and 800 for compounding.28 NABP offers a Safe Site Search Tool to verify the legitimacy of a website selling compounded semaglutide to share with patients. Additionally, the FDA and news agencies have urged providers to counsel patients on administration techniques and dosing when providing patients with compounded semaglutide.

The US Senate Health, Education, Labor, and Pensions Committee found that unless prices dramatically decline, Wegovy and other weight loss drugs could push Americans to spend $1 trillion per year on prescription drugs and “have the potential to bankrupt Medicare, Medicaid, and our entire health care system.”29 Unable to sustain the high utilization and costs for these medications, health plans have begun excluding coverage of FDA-approved GLP-1 weight loss medications, which in turn may further contribute to the increased use of and demand for compounded semaglutide.

Limitations

Only 1 search engine was used to identify publications. Due to the novelty of this topic, few scholarly articles have been published.

CONCLUSIONS

As the popularity of semaglutide continues to increase, it is important for health care providers to be well informed about the use of compounded semaglutide. Directing patients to lawful sources of compounded semaglutide and providing counseling regarding semaglutide’s administration are key factors in reducing the risks associated with use of a compounded semaglutide product. The demand for compounded semaglutide products highlights the need for further research to better understand the safety, efficacy, and regulatory issues associated with these and other compounded medications.

Patients who use compounded semaglutide may experience negative health outcomes and contribute to increased spending in the health care system. Health care professionals should be vigilant in identifying patients who are obtaining compounded semaglutide and provide additional resources to these individuals, including helping them locate accredited compounding pharmacies and counseling them on dosage and administration—to minimize safety concerns. Pharmacists can foster open and honest communication by creating a supportive and nonjudgmental atmosphere based on trust and respect, which is crucial for effective patient care and medication management.30

Author Affiliations: Blue Cross Blue Shield of Michigan (GL, MJ, MM, TS), Detroit, MI.

Source of Funding: None.

Author Disclosures: Ms Liu was employed by Blue Cross Blue Shield of Michigan at the time of writing this article and is currently affiliated with Michigan Medicine; Michigan Medicine has no connection to this article. Drs Jarema, Mo, and Stievater are employed by Blue Cross Blue Shield of Michigan, which does not cover compounded semaglutide.

Authorship Information: Concept and design (GL, MJ, MM, TS); acquisition of data (GL, MJ); analysis and interpretation of data (GL, MJ); drafting of the manuscript (GL, MJ, MM, TS); critical revision of the manuscript for important intellectual content (MJ, MM); and supervision (MM, TS).

Address Correspondence to: Marissa Jarema, PharmD, Blue Cross Blue Shield of Michigan, 600 E Lafayette Blvd, Mail Code 512C, Detroit, MI 48226. Email: mjarema@bcbsm.com.

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