Many of these unlawful and unauthorized shipments were explicitly tagged for compounding, according to a new analysis. Separately, a group of state attorneys general has raised concerns about the unsafe GLP-1 drugs finding their way to American consumers.
The U.S. is receiving “problematic shipments” of unauthorized and potentially unsafe ingredients that are used to produce compounded forms of GLP-1 weight-loss drugs, according to a Thursday report from The Partnership for Safe Medicines.
Separately, a bipartisan coalition of state attorney generals have urged acting FDA Commissioner Sara Brenner to act on scammers and counterfeit GLP-1 drugs they say are infiltrating the supply chain, though the group did not refer specifically to the Partnership for Safe Medicines report.
In a letter sent Thursday and signed by 38 attorney generals from Tennessee, Colorado, Alaska, Illinois and others, the coalition stated that due to shortages of Novo Nordisk’s GLP-1 drugs Ozempic and Wegovy, fake versions of these drugs, potentially carrying contaminants and other unknown drugs are being sold to U.S. consumers.
“Most consumers are not equipped to determine if their medication is legitimate or fake. The FDA must work with federal partners like the Department of Homeland Security to intercept counterfeit GLP-1 drugs before they reach unsuspecting consumers,” the attorneys general wrote.
The letter notes that some scammers simply repackage insulin and sell it as Ozempic, while others simply illegally sell the active ingredients of GLP-1 drugs directly to consumers. The attorneys general also point fingers directly at compounding pharmacies, which they allege sometimes participate in illicit GLP-1–related activities.
The letter comes as the Partnership for Safe Medicines’ report details an analysis of nearly 2,500 shipments arriving from September 2023 to January 2025. Of these, the nonprofit flagged 239 “problematic” batches of semaglutide (marketed by Novo Nordisk as Ozempic and Wegovy) and tirzepatide (sold by Eli Lilly as Mounjaro and Zepbound) coming from “unregistered entities” that have no traceable semaglutide or tirzepatide products registered with the FDA.
“Many of these shipments were allowed to enter the U.S. anyway, a violation of federal law,” according to the report, pointing out that many of these unregistered ingredients were “explicitly marked for compounding” and have “the potential to harm many Americans.”
In light of these findings, the Partnership for Safe Medicines, a collection of nonprofits that focus on counterfeit drugs and patient advocacy , called on compounders of GLP-1 drugs “to be more transparent” with how and where they source their pharmaceutical ingredients. Meanwhile, the FDA, alongside the U.S. Customs and Border Protection, should employ tighter checks to intercept these shipments, according to the organization.
The FDA should also flag what the Partnership calls “rogue foreign” manufacturers so that future shipments from these sources are more easily detected and, if needed, blocked.
Compounding—the process by which pharmacies and other manufacturers alters the formulation FDA-approved drugs, a practice sanctioned by Congress in times of drug shortages—has recently become a flashpoint for the industry and regulators. Compounded medicines can help shore up drug supplies while pharma companies are unable to meet patient demand with their manufacturing capacities but can steal market share from branded drugmakers when drugs are not in short supply.
Novo and Lilly, in an attempt to block compounded GLP-1s from the market, have launched respective legal offensives against wellness clinics and pharmacies. Novo, for instance, filed a flurry of lawsuits in June 2023, eventually winning permanent injunctions in February 2024. Likewise, Lilly recently sued three retailers that were allegedly selling remixed versions of tirzepatide.
The FDA, for its part, has also largely been opposed to compounding. The regulator over the past years has consistently been warning consumers against the practice, flagging potential safety risks of unapproved medications.
In October 2024, the regulator dealt a blow to compounders when it formally took tirzepatide off its shortage list, effectively disallowing the manufacturing and commercialization of compounded versions of the drug. Trade group Outsourcing Facilities Association hit back with a lawsuit, calling the FDA’s move “arbitrary” and one that lacked “any semblance of lawful process.”
Ultimately, however, following a months-long review, the FDA doubled down on its original declaration, announcing in December 2024 that tirzepatide is no longer in shortage. Compounders were given 60 to 90 days to cease their production of compounded GLP-1s. The FDA has also confirmed that shortages of Novo’s Wegovy and Ozempic have been resolved, removing the drugs from the shortage list, Reuters reported Friday.
Meanwhile, the agency has also issued warning letters to another group making offbrand GLP-1s: makers of research peptides, which together with compounders have created a thriving shadow market for these in-demand drugs.
Editor’s note (Feb. 21): This story was updated to include news about the bipartisan coalition of state attorney generals and the FDA’s removal of Novo Nordisk’s GLP-1s from the agency’s shortage list.
