Last week, the FDA proposed to remove semaglutide, tirzepatide, and liraglutide from the list of drugs that compounding pharmacies are permitted to produce. If that proposal is finalized, the compounded versions of these drugs — sold for $30 to $200 a month by pharmacies that have been making them during a period of shortage — will no longer be legal to dispense.
The branded versions cost between $900 and $1,300 a month without insurance. Most insurance plans do not cover them for weight loss, only for type 2 diabetes or a narrow set of metabolic conditions. The compounded versions exist because the FDA, during a period when Wegovy and Ozempic were officially listed as in shortage, permitted compounding as an alternative supply source. That shortage designation has been lifted. The FDA’s position is that the justification for compounding no longer exists.
The number of Americans currently using compounded semaglutide is estimated at somewhere between 1.5 and 2 million. They are not all wealthy. The compounded version, whatever its regulatory status, is the version that made this class of drugs accessible to people who could not pay four figures a month for a brand-name injection. Primary care physicians have been prescribing it. Telehealth platforms built their businesses around it. Patients managing serious weight-related metabolic conditions have structured their health around it.
The pharmaceutical industry’s position is straightforward: compounding pharmacies are producing unlicensed copies of patented drugs and undercutting the branded product. That is true. It is also true that the patent holders — Novo Nordisk and Eli Lilly — have done nothing to make the branded versions affordable to the population that needs them. The list price of Wegovy in the United States is roughly ten times what it costs in Germany. The drug is the same molecule. The price is a function of the American pharmaceutical market’s structure, not of what the drug costs to make.
The 90-day comment period is open. The proposal is not yet final. Compounding pharmacies are already preparing legal challenges on the grounds that the shortage was not fully resolved and that patient access constitutes a public health consideration that the FDA is obligated to weigh. Those arguments may or may not prevail.
What is not in dispute is the arithmetic. If the compounded versions disappear and the branded versions remain at current prices, most of the 1.5 to 2 million people currently using them will stop. Some will find insurance coverage. Many will not. The metabolic conditions they are managing — insulin resistance, visceral obesity, cardiovascular risk factors — will continue without the drug. The costs of those conditions, in hospitalizations and downstream care, will fall somewhere. They always do. The question is who pays them and when.
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