March 14, 2025
On Mar. 5, a judge denied a request from the Outsourcing Facilities Association (OFA), an industry group for compounding pharmacies, to block the FDA’s attempt to stop the production of compounded tirzepatide. Generally, making copies of brand-name drugs is not legal until their patents expire. But there are exceptions: Compounding pharmacies can fill the gap when a drug is in shortage.
The FDA declared the tirzepatide shortage over in October, a move that theoretically should’ve made most compounded versions illegal. Instead, their legal status has been in limbo since the OFA sued the FDA, claiming that the end of the shortage was declared prematurely. But a federal judge isn’t buying it. Compounding pharmacies now have until March 19 to stop making tirzepatide, according to the FDA’s latest guidance.
A similar legal battle is playing out over compounded semaglutide — the active ingredient in Ozempic and Wegovy — but the court case remains ongoing. Smaller compounding pharmacies will have to stop making compounded semaglutide on April 22. Larger compounding facilities that mass-produce the drugs have until May 22.
Companies prescribing compounded GLP-1s now seem to be trying to justify the prescriptions based on compounding’s second purpose: a need for customized versions of the drugs. If a patient requires a dose of an FDA-approved medication that’s not mass-produced, compounders can legally make it, regardless of shortages. The same is true when, for example, a patient is allergic to an ingredient in an FDA-approved drug and needs a version of it made without that component.
Some compounded GLP-1 users are trying to prepare by stockpiling, taking advantage of providers’ offers to prescribe six months’ worth of refills. A subset of those people are trying to wean themselves off of tirzepatide even though GLP-1s are intended for long-term use. But when huge numbers of patients, which is in the millions, suddenly need these personalized formulations, it’s likely to catch the attention of litigious drugmakers. It’s a legal risk to compounding pharmacies that could face lawsuits from huge companies: Novo Nordisk and Eli Lily. So prescribing these supposed “custom” compounded injections is “a practice that is worrisome, and it’s worrisome because it positions compounding in a way that it was not intended to be. It pokes the bear (Novo, Lilly) – the large pharmaceutical companies. The poker is the cottage industry of opportunists that has sprung up around compounded weight loss drugs (compounders and telehealth companies and MDs that have jumped on the profit bandwagon.
DietBusinessWatch Commentary
Hey, we all knew this was coming. The compounders tried to appeal, and lost. No, adding vitamin B-12 to the meds does NOT make it a new medication. Compounders will NOT win in massive lawsuits by Novo and Lilly. It’s time to realize that. The war is over. The era of cheap semaglutide and other GLP-1s is over. The era of easy weight loss without exercise, without changing one’s eating habits, to better food, without behavior modification, is over. Dieters have been spoiled. It’s time for this “wild west” profit-driven market to settle down. And, consumers will suffer. But, they do have an alternative – using meal replacements high in protein and using non-medical weight loss programs like Weight Watchers, NutriSystem and other companies.