Regulatory discretion is not always the better part of valor. In fact, when it comes to the illegal, unregulated, and unsafe manufacturing of moonshine GLP-1 products, it’s regulatory malpractice – with broad negative public health consequences.
Because of the FDA’s unwillingness to exercise its bully pulpit and existing authorities relative to post-shortage GLP-1 compounding, the situation is spinning out of control. Nature abhors a vacuum and the FDA’s lack of oversight and action has created a regulatory vacuum. Inactions have consequences.
Under Section 503B of the Food, Drug, and Cosmetics Act outsourcing facilities cannot compound any semaglutide or tirzepatide products unless they are on the FDA’s drug shortage list. This hasn’t been the case for semaglutide (active ingredient in Ozempic and Wegovy) for about 7 months and for tirzepatide (active ingredient in Mounjaro and Zepbound) for about 10 months. Actions taken by FDA – none.
To be clear, the fact semaglutide and tirzepatide are not in shortage is not merely a limitation on making “essentially a copy” of Novo Nordisk’s and Lilly’s FDA-approved medicines. 503Bs are completely barred from bulk compounding any semaglutide or tirzepatide medicines. The Outsourcing Facilities Association (OFA) itself has repeatedly acknowledged in its court filings that the consequence of FDA’s removal of tirzepatide from the shortage list is that 503B facilities like its members cannot compound tirzepatide. Actions taken by the FDA – none.
With the FDA silently sitting on the sidelines, two 503B outsourcing facilities outsourcing facilities -- BPI and ProRx, registered in Florida and Pennsylvania, respectively – have recently resumed manufacturing and aggressively marketing compounded semaglutide and tirzepatide products despite a clear legal prohibition.
BPI is offering compounded tirzepatide through sales agents, including DiversifyRx and Medical Results Network, and telehealth companies, such as Club Compound and Good Life Meds. Some suppliers link customers to promotional pamphlets advertising BPI’s bulk compounded semaglutide and tirzepatide (in 25 packs).
In online communities, patients have widely reported accessing semaglutide and tirzepatide compounded by BPI and ProRx in recent weeks. Despite the clear prohibition on 503B compounding, actions taken by the FDA – none.
This regulatory dereliction is more concerning given ProRx’s concerning safety record, including with its compounding of semaglutide and tirzepatide. FDA identified numerous issues at ProRx’s compounding facility in in 2024, which ProRx failed to remedy, leading FDA to issue a formal warning letter in March 2025.
In particular, “investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions.” According to FDA, these “serious deficiencies” in ProRx’s practices “put patients at risk.” Following the inspection, ProRx recalled over 12,000 vials of compounded semaglutide and over 3,200 vials of compounded tirzepatide due to lack of assurance of sterility.
BPI has a similar history of safety and other legal issues. Following a 2021 inspection of BPI, FDA detailed numerous violations, including failure to use proper equipment, failure to adequately vet suppliers, and failure to thoroughly assess the risks associated with an injectable drug product. FDA observed further violations in February 2025, including that BPI was improperly labeling its compounded semaglutide and tirzepatide products.
It’s worth keeping in mind that BPI is a subsidiary of Belcher Pharmaceuticals LLC, which has a comparable history of issues. In 2024, Belcher Pharmaceuticals was inspected by FDA and found to have numerous violations, including “fail[ure] to conduct testing for impurities” before releasing injectable testosterone packages.
Further, in 2020, two Belcher executives were convicted as part of a Medicare fraud scheme, including one who pleaded guilty to “introduction of misbranded drugs into interstate commerce with the intent to defraud and mislead” and agreed to pay the federal government $2 million for his role in the scheme.
Regulatory inaction is inexcusable. All the more so when it yields to actors with records like these.
The Food, Drug, and Cosmetic Act provides numerous tools for federal regulators to put a stop to unlawful compounding—they just need the will to act.
- Violators can be subject to criminal penalties, including fines and imprisonment. 26 U.S.C. § 333(a).
- FDA and DOJ can also seek an injunction to put a stop to unlawful compounding. Id. § 332.
- And illegally compounded products are also subject to seizure by federal authorities. Id. § 333(a).
Are we ready for what will happen if FDA fails to act for so long that it loses regulatory authority? Do we want rogue companies making unregulated moonshine medicines? I, for one, do not. If federal authorities continue to fail to act, these illegal practices will continue unchecked, and there is no reason to believe these unlawful actors will not continue to push the limits further and further – eroding confidence in and undermining the safety of the U.S. drug supply chain.
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris School of Medicine.
