Compounding pharmacies are on the clock.
And they've missed their deadline for more than a year.
The FDA declared the shortages of semaglutide and tirzepatide -- the active ingredients in blockbuster GLP-1 weight-loss medications -- over in early 2025. The regulatory ramifications were clear: compounding pharmacies were required to close their GLP-1 operations on a defined federal timeline.
There are two categories of licensed compounders. 503A pharmacies prepare customized medications for individual patients with a specific clinical need, such as liquid formulations for a child who can't swallow a pill or a version of a drug with an allergen removed. 503B outsourcing facilities operate at a much larger scale, producing compounded drugs in bulk, primarily for hospitals and clinical settings.
Both types of facilities are temporarily allowed to create "copies" of FDA-approved drugs only when those drugs are officially listed as being in shortage. In 2024, semaglutide and tirzepatide were placed on the FDA's shortage list, opening the door for compounders to produce the alternatives. When the shortage ended, so did that authorization.
503A compounding pharmacies were required to wind down operations for tirzepatide by February 2025 and for semaglutide by April 2025. 503B outsourcing facilities had until March and May of 2025, respectively.
One might assume that explicit federal deadlines, communicated by the nation's premier drug regulator, would be treated as exactly that -- deadlines. The record suggests otherwise.
An FDA inspection of 503B outsourcing facility ProRX conducted in September 2025 found the company still compounding tirzepatide months after its phase-out date had passed. According to a subsequent announcement by ProRX's own COO, the company did not make the decision to stop until April 2026, a full year after the FDA's deadline. Other 503B facilities published their own similar announcements in the months that followed.
If a restaurant repeatedly violated health codes, regulators would shut its doors.
But somehow -- when the stakes are even higher, when the safety of millions of patients is in direct jeopardy -- officials still are not enforcing the rules or holding the compounders who routinely violate these rules accountable.
The FDA and state regulators cannot wait any longer.
This is not a matter of regulatory ambiguity. The agency's guidance is explicit, and 503B outsourcing facilities -- large-scale, commercial-grade operations -- surely have the legal and compliance infrastructure to understand their obligations. The more straightforward explanation is economic: The compounded GLP-1 market is extraordinarily lucrative, and some operators appear to have calculated that continued production is worth the risk of potential enforcement.
The FDA's lack of enforcement is having real costs to patients.
During this period of continued compounding after the deadlines to wind down operations, a Kentucky resident named Jimmie Wilson suffered acute liver failure after taking a compounded weight-loss injection, ultimately requiring an emergency transplant.
A peer-reviewed study published during this same window found that adverse medical events associated with compounded GLP-1 medications were both more frequent and more severe than those linked to FDA-approved versions.
Separately, an FDA inspection of a compounding active pharmaceutical ingredient (API) supplier listed on the agency's own "Green List" -- a designation intended to signal safety -- revealed that the vendor had been sourcing material from an unlisted third party and repackaging it under its own name.
And California regulators moved to revoke the license of Texas-based Empower Pharmacy after finding that the company had shipped compounded medications to California patients made with ingredients from facilities never registered with (and therefore never inspected by) the FDA.
These compliance failures represent a pattern: When faced with inconvenient regulations, the industry chooses to chase profits rather than prioritize patient safety. And when these violations are not met with enforcement, patients are harmed.
Compounding pharmacies serve a legitimate and important function in the U.S. healthcare system and should be allowed to continue meeting individual patient needs. But that role carries with it an obligation to operate within the carefully constructed framework Congress and the FDA have established, built precisely because compounded drugs are not subject to the same pre-market safety and efficacy reviews as approved medications.
The past year has been an instructive, if concerning, demonstration of what happens when that obligation is treated as optional. The FDA now has a clear picture of how a subset of this industry perceives enforcement as distant and unlikely.
Effective regulation ultimately depends on the credibility of consequences. The compounding sector has signaled that voluntary compliance, absent active accountability, is no guarantee. The FDA and state regulators must take note and act.
Shabbir Imber Safdar is the executive director of the Partnership for Safe Medicines and hosts the True Crime and Medicine Safety and the Imitation Nation "all things counterfeit" podcast. He sits on the editorial board of the Journal of Illicit Trade, Financial Crime, and Compliance (JITFCC)."
