Illicit GLP-1 Compounding Is a Public Safety Threat

Americans trust that the medications they take are safe. That trust rests on a simple assumption: the ingredients entering the United States have been properly vetted before reaching patients. They rely on the expectation that medicines meet rigorous safety standards and that regulators will identify risks before dangerous or substandard products reach pharmacy shelves. The question today is whether our system can still deliver on that promise.

During my years in law enforcement, I learned that threats rarely arrive without warning. They develop when oversight lacks and weaknesses and vulnerabilities are left unaddressed until a crisis is already underway.

That is why the rapid expansion of illicit compounding should concern every American. As a former partner in a compounding pharmacy, I have seen how compounding enables pharmacists to prepare customized medications for patients with specific medical needs when commercially available options are unsuitable or unavailable, including during drug shortages. 

However, in the case of GLP-1 drugs, what was intended to be a narrow and carefully regulated practice is increasingly being exploited by bad actors to mass-produce unapproved compounded drugs outside the traditional regulatory framework. The FDA has identified compounded products contaminated with harmful bacteria, containing unapproved ingredients not fit for human consumption, and made with research-grade substances never intended for patients. 

These illicit compounding practices bypass the rigorous review, manufacturing standards, and quality controls that Americans expect from FDA-approved medications, creating dangerous gaps in oversight and enforcement that allow unsafe products to enter the marketplace. These weaknesses are not abstract, they represent real vulnerabilities that can be exploited, making it harder for regulators and law enforcement to detect, deter, and stop harmful products before they reach patients.

From a law enforcement perspective, these gaps are not theoretical, they are opportunities. Criminal networks actively search for weaknesses in supply chains. When large-scale compounders operate without the same reporting and inspection requirements as traditional manufacturers, they create an unverified and largely unregulated parallel system. That system makes it harder for regulators to detect and stop dangerous products before they reach patients. 

Even more troubling is the growing overlap between illicit compounding supply chains and those tied to transnational crime. Evidence shows that some of the same Chinese chemical manufacturers supplying unapproved compounding ingredients are also linked to the production of fentanyl precursors. Recent analysis has found that actors previously associated with fentanyl trafficking are now marketing peptide and GLP-1 ingredients through the same gray-market channels. Americans deserve better than a system where the ingredients used in their medications may originate from the same networks responsible for fueling the opioid crisis.

Congress has an opportunity to act before this threat escalates further. The Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act would strengthen oversight of high-volume compounding by requiring transparency in production, mandating FDA inspections before products are distributed, and closing loopholes that allow large-scale operations to function without appropriate accountability. These reforms would bring greater visibility to a supply chain that currently operates with too many unknowns and would reinforce the integrity of our pharmaceutical borders.

As a retired Sheriff, I can attest that law enforcement is often called when the damage has already been done. But our responsibility is also to recognize emerging risks and act before they become crises. We have seen what happens when dangerous supply chains are allowed to grow unchecked. Illicit compounding presents a similar warning sign. Congress should act now to address this vulnerability, strengthen oversight, and protect the safety of American patients before this issue becomes the next public health emergency.

Sheriff Bob White (Ret.) is a 35-year law enforcement veteran and former Sheriff of Pasco County, Florida, where he served for over a decade after being elected to three consecutive terms.