Subject: BREAKING: Two Stories That Impact Compounded GLP-1
From: Dave Knapp from On The Pen <[email-masked]>
To: [email-masked]
Date: Fri, 1 May 2026 02:32:22 +0000
List-Id: <onthepen.substack.com>

View this post on the web at https://onthepen.substack.com/p/breaking-two-stories-that-impact

A federal judge just handed Eli Lilly a mixed ruling in its lawsuit against Empower Pharmacy. At almost the same time, the FDA quietly proposed something that could matter even more long term: formally declaring that there is no “clinical need” to compound semaglutide, tirzepatide, or liraglutide at scale. Two separate developments. Two separate processes. But they are pointing in the same direction, and patients who have been riding the compounded GLP-1 wave need to understand what that direction looks like.
The Court Ruling: What Was Dismissed, and What Was Not
The Empower ruling dismissed Lilly’s Lanham Act claim, which was the company’s attempt to frame Empower’s marketing as unlawful false advertising. The reason was procedural, not philosophical. Lilly could not demonstrate a direct enough link between Empower’s advertising and measurable harm. The court was not willing to accept the narrative without proof. Courts are not simply handing Lilly or Novo whatever they ask for in their respective lawsuits.
Interestingly, the court allowed Lilly’s state-level claims to move forward, and those claims hinge on something much more fundamental than marketing. They hinge on whether compounded tirzepatide products can be sold at all under state laws governing unapproved drugs. The fight is no longer about how these products are advertised. It is about whether they have a legal right to exist in the first place, something courts thus far have preferred to default back to the FDA.
In Lilly’s separate case against Mochi Health [ https://substack.com/redirect/d7581340-3911-4a99-bc7a-8aafb52e104e?j=eyJ1IjoiNGl3b2U2In0.sVDxRtmZ85v8kfdamY0krRXGMy3p768BWtuZifRB-Zs ], a judge who had previously signaled skepticism recently acknowledged that Lilly may have a plausible path forward tied to reputational harm and lost sales. Different case, different defendant, same structural outcome: federal claims narrowed, but the core challenge to the compounding model still standing and moving forward. Lilly is building a consistent playbook across multiple courtrooms, and so far the courts seem to be willing to entertain at least some of their claims.
The FDA Proposal: Affordability Is Not a Clinical Need
While that legal fight unfolds, the FDA has continued to signal a serious crackdown on compounded GLP-1’s, this week proposing not to include semaglutide, tirzepatide, or liraglutide on the 503B Bulks List. That is the list that determines which substances outsourcing facilities can compound from at scale. The agency was explicit about its reasoning. It stated that there is no clinical need for outsourcing facilities to compound these drugs from bulk substances. It stated that cost, access, and convenience do not qualify as clinical need. It stated that the existence of FDA-approved products undermines the justification for compounded alternatives.
The agency also drew a hard line around shortage justifications. Shortages can justify compounding while they exist. Once resolved, that pathway narrows. That is the framework the FDA has laid out, and it does not leave much room for interpretation. At this point, given the complex legal battles that have ensued over branded GLP-1 shortages and compounding, one must wonder if the FDA is conceiving other ways to handle potential future shortages.
Through today’s (and other recent actions [ https://substack.com/redirect/d6c19076-cd5c-4beb-a6b3-5b3ebd1049f3?j=eyJ1IjoiNGl3b2U2In0.sVDxRtmZ85v8kfdamY0krRXGMy3p768BWtuZifRB-Zs ]), what the FDA is saying, plainly, is this: if a GLP-1 drug is approved and available, it does not believe it should be mass compounded, regardless of whether patients can afford it.
Why These Two Things Together Matter
Patients who have been on compounded GLP-1s have lived through cycles that would exhaust anyone. The excitement of finally finding something that worked. The scramble during shortages. The relief when compounding filled the gap. The uncertainty every time a new enforcement action dropped. The questions about what comes next. This community has been through a lot.
What is happening right now is not a single dramatic moment. It is the slow erosion of the conditions that made compounded GLP-1s possible in the first place. The legal system is allowing challenges that test whether these products can exist under state frameworks. The regulatory system is tightening the federal criteria that allowed them to flourish. Neither of those things, on its own, ends compounding. But together, they reduce the number of available pathways, and the people walking those pathways are the ones who feel each narrowing most directly.
The Reality for Patients
Patients did not turn to compounded GLP-1s because they wanted a workaround. They turned to them because the branded medications were out of stock, out of reach, imprecisely dosed, or excluded by their insurance. Compounding was not a loophole. For hundreds of thousands of people, it was the only path forward.
The FDA’s position is now clear. Affordability is not a clinical need. The courts have not yet ruled on the core question, but they are allowing it to be tested. If these trends continue, the likely outcome is not an overnight shutdown. It is something slower and, in some ways, harder. Fewer pharmacies willing to accept the legal exposure. Tighter regulatory interpretations. A gradual contraction of supply that happens without a headline moment to point to. 
Patients deserve to know that is what is being built, one ruling and one proposal at a time. Safety matters. But access matters too. And any framework that treats affordability as irrelevant has not actually solved the problem. It has simply decided that the people who cannot afford branded medication are not its problem to solve.

Unsubscribe https://substack.com/redirect/2/eyJlIjoiaHR0cHM6Ly9vbnRoZXBlbi5zdWJzdGFjay5jb20vYWN0aW9uL2Rpc2FibGVfZW1haWw_dG9rZW49ZXlKMWMyVnlYMmxrSWpveU56TTJNakl6T1Rnc0luQnZjM1JmYVdRaU9qRTVOakEyTWpRNU1Td2lhV0YwSWpveE56YzNOakF5T0RrNUxDSmxlSEFpT2pFNE1Ea3hNemc0T1Rrc0ltbHpjeUk2SW5CMVlpMDBPREE0T1Rreklpd2ljM1ZpSWpvaVpHbHpZV0pzWlY5bGJXRnBiQ0o5Lk1CNWN1Nm53WFFqS0pUc1ZMbVdQRjVNZWR0WjFSdEZyWE1jeDdIMzZMZW8iLCJwIjoxOTYwNjI0OTEsInMiOjQ4MDg5OTMsImYiOnRydWUsInUiOjI3MzYyMjM5OCwiaWF0IjoxNzc3NjAyODk5LCJleHAiOjIwOTMxNzg4OTksImlzcyI6InB1Yi0wIiwic3ViIjoibGluay1yZWRpcmVjdCJ9.PNHHhkf8sl2aqpzoENOD8EKoDu65LOnuvAaYqw6XRv0?