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Report: Compounded GLP-1 drugs pose safety, quality risks

Compounded GLP-1 drugs pose safety and quality risks, a recent report says, adding to the growing calls for tougher regulatory enforcement.

Alivia Kaylor, MSc
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Published: 21 Oct 2025

A recent Consumer Choice Center (CCC) report outlines the ongoing risks linked to compounded GLP-1 products and the actions policymakers should take to ensure patient safety.

The report adds to the growing industry concern that a shadow market born during the national shortage is exploiting federal loopholes to continue to sell illicit compounded versions of popular GLP-1 drugs used for weight loss, like semaglutide and tirzepatide.

This practice is confusing consumers and placing them at risk, the authors wrote.

"Patients fighting back against obesity and all its known comorbidities deserve safe, accountable and effective treatments, but knockoffs with unknown impurities are still flooding the market," Fred Roeder, Managing Director at CCC and co-author of the report, said in a press release.

This echoes similar findings published earlier this year by the Center for Medicine in the Public Interest.

Safety risks

Americans are injecting themselves with untested and unverified compounded GLP-1 drugs, the report noted, drawing on publicly available data, regulatory filings and independent analyses.

Many compounded drugs or their active pharmaceutical ingredients (APIs) arrive in the United States labeled "not for human consumption" or "for research use only" before being sold to consumers.

Compounded GLP-1 medications are not listed in the U.S. Pharmacopeia monographs, meaning their strength and purity are not benchmarked against any established reference standard, the CCC authors added.

As a result, manufacturers can choose not to test for heavy metals or other poisons, even if large portions of a batch could contain toxic substances, the report revealed.

The FDA has received 1,424 adverse-event reports associated with compounded GLP-1 drugs as of Sept. 9, 2025, including 329 hospitalizations and 23 deaths, according to the Adverse Event Reporting System.

The FDA cautioned, however, that these figures are likely underreported since 503A compounders are not required to submit adverse event information.

Yet, the public remains largely unaware of the dangers linked to compounded GLP-1 drugs.

According to a National Consumers League survey not included in the CCC review, 71% of respondents mistakenly believed these compounded GLP-1 versions undergo testing and are FDA-approved.

Regulatory gaps

The FDA and State pharmacy boards have failed to consistently enforce rules that state APIs must come from FDA-registered manufacturers.

In fact, data from Redica Systems included in the report shows that several facilities importing semaglutide have gone uninspected since 2000. A Brookings review also found that, among 11 companies reviewed between 2023 and 2024, three had never been inspected at all and yet were responsible for 20% of the imported product volume.

Meanwhile, three others, accounting for 44% of imports, were cited for violations. Another three companies had no good manufacturing practice observations recorded during the latest inspection, and only 2 out of the 11 facilities were violation-free.

The report states that the U.S. government already has the tools to act.

In the report, the authors criticize the FDA's newly created "Green List" for GLP-1 API imports, arguing that although the agency has the authority to intercept illegal shipments at the border, the policy doesn't require examination, sampling or testing.

Stronger regulatory oversight would eliminate bad actors, improve public safety and bring order back to the supply chain, experts say.

Earlier this year, 38 attorneys general sent a letter to the FDA urging the agency to protect consumers by exercising its legal authority to conduct investigations, inspections and enforcement actions.

In July, Senator Marsha Blackburn (R-Tenn.) and Tennessee AG Jonathan Skrmetti also sent a letter to the Federal Trade Commission, asking the agency to investigate websites that falsely claim their products are FDA-approved and use manipulative marketing tactics to target vulnerable patients.

Two months later, the FDA issued over 50 warning letters to various wellness clinics and telehealth platforms, including Hims & Hers Health, citing the unlawful sale of unapproved and misbranded drugs to U.S. consumers online.

Policy recommendations

Weak enforcement has allowed 503A compounding facilities to mass-produce untested GLP-1 medications with little regulatory oversight, the CCC authors said. Without stronger federal action against unlawful profiteering, patients using compounded GLP-1 therapies will continue to face risks they might not be aware of.

To prevent the circulation of unsafe GLP-1 drugs, the report recommends that federal regulators take the following actions:

  • Intercept high-risk shipments. The FDA must stop illicit APIs imports at the border and enforce sourcing from FDA-registered manufacturers.
  • Establish reference standards. Create U.S. Pharmacopeia monographs and require drug master files as reference standards for compounded GLP-1 drugs.
  • Require identicality. Compounded products must be identical to the reference-listed drug to minimize clinical risk.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.

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