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The increased production and use of compounded medication, in particular GLP-1s, could pose a significant threat to the health and well-being of patients, according to findings from the Food and Drug Administration.  

The background: Compounded pharmaceuticals are custom prescription drugs made for patients who have specific needs that standard medications cannot meet.

• Patients who require compounded drugs include those with allergies to certain inactive ingredients, those who cannot swallow pills and need their medications in liquid form and children who need flavorings added.  

How it works: Compounding pharmacies are allowed to make copies of FDA-approved drugs to meet these specific patient needs, or to fill gaps when drugs are in shortage.  

• Given the targeted nature of these use cases, these drugs are not FDA-approved and therefore do not undergo the same rigorous inspection for safety, efficacy or quality that traditional medicines do.  

The threat: In recent years, compounders have taken advantage of drug shortages, specifically of GLP-1s, to produce compounded versions en masse, even after the FDA has declared the shortages over. As the exceptions for compounded drugs were never intended to lead to the mass production of non-FDA-approved drugs, adverse events have occurred:  

• The FDA has received multiple reports of adverse effects due to dosing errors of compounded GLP-1s. These have included gastrointestinal effects (vomiting, nausea, abdominal pain), fainting, headache, migraine, acute pancreatitis and gallstones. Some patients required hospitalization. 
• In a May 2025 notice, the FDA said that the agency “continues to find concerning quality and safety problems during inspections of [compounding] outsourcing facilities.” The FDA has also issued warnings to compounders that have concerning safety and sterility practices.
• An April 2025 Brookings Institution report found that the three Chinese firms responsible for 20% of the semaglutide (the active ingredient in some GLP-1s) imported into the United States between March 2023 and September 2024 for compounding have never been inspected by the FDA.
• Meanwhile, another three Chinese firms, which account for more than 44% of imports, were cited for violations during inspections. 

Calling on the FDA: Sen. Jim Banks (R-IN) sent a letter to then-Acting FDA Commissioner Sarah Brenner raising concerns about the use of active pharmaceutical ingredients from unregistered or inspected sources in compounded GLP-1s.

• Sen. Banks noted that “as of December 31, 2024, the FDA’s Adverse Event Reporting System database lists more than 900 cases of adverse health events associated with compounded ‘semaglutide’ and ‘tirzepatide,’ of which 17 involved deaths.”  
• “These adverse events represent more than quadruple the number of adverse events recorded for all compounded drugs in FY 2022.”  

Other voices:  Additionally, 38 state attorneys general sent a letter to the FDA in February calling on the agency to take action against the unlawful sale and distribution of illegal compounded GLP-1s.   

• Tennessee Attorney General Jonathan Skrmetti also issued a warning that highlighted safety concerns about compounded GLP-1s.  

Counterfeiting: In addition to the threats posed by compounding, patients are increasingly at risk from counterfeit GLP-1s as well.

• Last week, a bipartisan group of more than 80 members of Congress, led by Rep. Richard Hudson (R-NC), sent a letter to FDA Commissioner Marty Makary highlighting the “surge in illegal and counterfeit anti-obesity medications [which] pose an increased risk to patient safety with sometimes fatal consequences.” 

What manufacturers are doing: Pharmaceutical companies are implementing programs that allow patients to buy GLP-1s directly from manufacturers at a reduced rate. This reduces the cost burden and eases safety concerns for patients. 

The last word: “Pharmaceutical manufacturers are held to rigorous standards for safety and efficacy,” said NAM Managing Vice President of Policy Charles Crain. “Circumventing these standards via mass production of compounded drugs undermines patient health and erodes trust in U.S. biopharmaceutical innovation. Policymakers should carefully consider reforms to ensure patient safety is the top priority.”