I often say that my entire professional career has been in drugs and money. I’ve been a licensed pharmacist for more than 50 years and a bank president for almost 30. In both pharmacy and banking, compounding can be good and very bad. For your money, compounded interest on investments can make you rich, but compounded interest on credit cards can bury you in debt. For your drugs, compounding done properly can save your life, but when done wrong can kill you. The moral of the story is when compounding goes bad—either in drugs or money—it could end in your financial or actual burial.
Drug compounding exists as a professional tool to meet individual patient needs, such as taking a pill and turning it into a lollipop for a child or into a pain cream for a dying cancer patient who can’t swallow. What we are witnessing today is something else entirely: mass-production of GLP-1 products mixed with unapproved additives, sold through telehealth platforms and medical spas with no clinical testing, no batch consistency requirements, and very little meaningful accountability when something goes wrong.
This new frontier of “personalization” puts patients at risk and undermines the legitimate compounding practices that so many of my colleagues and I have dedicated our careers to. Driving it is a new breed of faux-pharmacists who have no relationship with the patient whatsoever – and no intention of having one. Of particular concern, they have partnered with mass-compounders to structure their operations to look and act like manufacturers – while sidestepping the very regulatory guardrails that so closely govern their FDA-approved counterparts.
The consequences are already documented. In Kentucky, a woman needed an emergency liver transplant after taking compounded tirzepatide – an active ingredient in GLP-1 medications – mixed with vitamin B12. In Washington, a compounding facility hired day laborers from a Home Depot parking lot to package and ship medications – giving them access to private patient information. Since 2022, over 75,000 compounded GLP-1 products have been recalled. When expanded to all compounded products, that number tops 650,000. Because most compounders have no obligation to report adverse events, the true scope of harm is almost certainly larger.
The clearest sign that something is broken is how little many consumers understand about the products they are buying. More than half (51 percent) of GLP-1 users mistakenly believe that compounded GLP-1s have been approved by the U.S. Food and Drug Administration (FDA). They are not – compounded products do not undergo gold standard clinical trials nor are they approved by the FDA for safety, quality, or efficacy. Independent testing found that some products contained no semaglutide at all; others showed impurity levels as high as 86 percent. While an FDA-approved manufacturer with those results would face immediate enforcement actions, mass compounders do not—largely in part because they have structured their operations to manipulate exemptions designed for a neighborhood pharmacist filling a single patient’s unique prescription, not a nationwide commercial operation.
Over the course of my career as a pharmacist, Executive Director of the Louisiana State Board of Pharmacy, and state senator, I’ve seen this pattern before. As a senator, I led a campaign called “Ask Before You Eat” which fought to protect Louisiana consumers from imported, and often times contaminated, foreign seafood misrepresented as locally caught. The lesson then is the same as now: when profit motive outpaces oversight, consumers end up paying the price.
That’s why Americans for Safe and Effective Medicines (ASEM) is encouraging every consumer to ask, “what’s in this?”—whether they are ordering a bowl of gumbo at a restaurant or injecting a medication at home. Patients deserve to know what they are putting in their bodies and that their treatments are safe. That starts with robust FDA enforcement against illicit mass compounders, stronger oversight of foreign ingredients compromising the U.S. supply chain, and real consequences for the telehealth platforms and medical spas deceiving consumers about what they are actually taking.
Compounding, when done right, saves lives. When done wrong – without oversight, without accountability, and without honesty – it can end them. People deserve to know what’s in their medication, where it came from, and whether it has been properly tested and regulated. Too many are being denied that information by the very people selling them the medicine. That is not a patient failure; it is an accountability failure – and regulators, lawmakers, and the industry have an obligation to fix it.
Fred H. Mills, Jr. is a compounding pharmacist, former Louisiana State Senator, and former Executive Director of the Louisiana State Board of Pharmacy. He is Chief Policy Officer of the Americans for Safe and Effective Medicines (ASEM).
