FDA Is Right to Prohibit Mass Production of Unapproved GLP-1 Drugs

By Kirsten Axelsen 

Millions of Americans rely on GLP-1 medications for weight loss and diabetes management. Yet a growing share of what’s being sold to them aren’t the FDA-approved products they think they’re getting—they’re unapproved copies, compounded without the clinical testing, manufacturing oversight, or safety monitoring the real drugs underwent.

There are two types of treatments circulating in the United States. The first is medicines that have been approved by FDA after their manufacturers submitted data from multiple clinical trials, dosing studies, and other sources describing the drug substances, drug product formulations, and manufacturing processes, among other information. The second is compounded versions of medications that have not received FDA approval and have not been tested for safety and efficacy in clinical trials.

Compounded drugs are regulated, but distinctly from FDA-approved medicines. Under the Drug Quality and Security Act, 503A pharmacies may compound patient-specific prescriptions, while 503B outsourcing facilities may compound without patient-specific prescriptions provided they meet good manufacturing practice requirements, register with the FDA, and comply with other statutory conditions. 503B pharmacies typically sell to providers such as hospitals or telemedicine sites. Given their scale, these facilities are regulated by the FDA with more rigorous standards and requirements than 503A pharmacies.

Compounding is permitted in narrow circumstances, such as in the case of a drug shortage for 503B outsourcing facilities or when an FDA-approved medicine does not meet a specific patient need, such as an allergy to an inactive ingredient or an inability to swallow a pill. In other words, FDA may allow compounding in limited circumstances only where the need justifies the risk.

After the GLP-1 drug shortage was resolved, FDA made clear that 503B outsourcing facilities were prohibited from continuing to mass compound these products. Despite this, many continued to produce compounded versions and tried to reverse the FDA’s actions. First, compounders sued FDA to overturn its determination that the GLP-1 shortage had ended—and lost.[1] Compounders then nominated multiple GLP-1 products to be included on the 503B bulks list.

Now that the GLP-1 drug shortage has been resolved and multiple forms and doses are widely available, including at deeply discounted prices, FDA is proposing to deny the compounders’ nomination of three GLP-1s—semaglutide, tirzepatide, and liraglutide—for the 503B bulks list, maintaining the current exclusion.[2] Outsourcing facilities have never had authority to compound these in bulk outside of the shortage. FDA’s proposed exclusion of GLP-1 ingredients is consistent with the law and protects patients.

FDA sets rigorous standards for a drug to be approved and manufactured. Achieving FDA approval requires years of clinical testing, demonstration and continued compliance of safe and reliable manufacturing sites, and extensive post-approval safety monitoring. In limited circumstances, FDA allows certain pharmacies to create a non-FDA approved form of a compounded drug, but their finished products are not subject to the same degree of testing as FDA-approved drugs.

When the highly popular GLP-1 drugs were placed on the FDA shortage list in 2022, an industry of online companies selling compounded GLP-1 drugs proliferated. Purchasing compounded drugs, particularly in a form, strength, or combination that has not been tested clinically, poses a health risk; FDA has issued a number of warnings to compounders and telehealth companies associated with compounded GLP-1s.

On many websites selling these products, it was not always clear to consumers that they were taking a compounded, non-FDA approved drug.[3] Although FDA resolved the shortages in 2024 and 2025, the online promotion of unapproved drugs continues, and there are still hundreds of adverse event reports and multiple reported deaths in connection with compounded GLP-1 medicines. These reports do not establish causation but indicate potential safety signals warranting scrutiny.

Even with FDA oversight, significant risks remain. In the first six months of 2026, FDA issued 50 warning letters to compounding facilities producing semaglutide or tirzepatide. These warnings cited violations including selling adulterated and unapproved new drugs, misbranded drugs, and unlawful sales to U.S. consumers over the internet through telehealth platforms. The violations encompassed failures in sanitary conditions, failures to report adverse health outcomes, and mislabeling. An analysis of reported adverse events revealed that people taking compounded drugs were more likely to be hospitalized, experience prescribing errors, and encounter issues due to contaminated drugs compared to people taking FDA-approved versions.[4]

Even when manufacturing facilities comply with Good Manufacturing Practices, risks associated with compounded medicines remain. These include dosing errors with drugs that do not bear the same reviewed labels and instructions as FDA-approved versions. Additionally, the use of untested combinations, such as adding B-12, can generate reactions or leave impurities in the finished drug.[5]

Despite these documented risks, the compounding industry persists. Even after the companies that hold the rights to sell FDA-approved GLP-1s invested billions in U.S. manufacturing to resolve the drug shortages, online pharmacies continue today to heavily promote compounded versions of these drugs.

Some argue that compounding serves an affordability need. That argument is increasingly outdated because the affordability gap has largely been closed. The companies that make FDA-approved GLP-1 medicines now offer them to consumers for $149 to $249, eliminating cost as a justification for taking on the risk of stretching the rules for creators of unapproved drugs.   

FDA is correct to determine that there is no clinical need to mass-produce compounded GLP-1 drugs in forms, strengths, or combinations untested in clinical studies. FDA should continue on its course and deny the nomination of GLP-1 substances from the list approved for mass compounding and act decisively against any pharmacies that are continuing to mass produce compounded versions of drugs without clinical or patient need.

[1] https://www.jdsupra.com/legalnews/fda-moves-to-shut-the-door-on-large-4245490/

[2] https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list

[3] https://medicine.yale.edu/news-article/new-study-finds-online-advertising-for-compounded-diabetes-and-weight-loss-drugs-may-mislead-consumers/

[4] https://www.tandfonline.com/doi/abs/10.1080/14740338.2025.2499670

[5] https://www.tandfonline.com/doi/full/10.1080/14740338.2026.2663185

 

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