In an exclusive interview last night with Scott Brunner, CEO of the Alliance for Pharmacy Compounding, we uncovered a bombshell: Eli Lilly has been working quietly but diligently on additional means to remove compounded versions of tirzepatide—the active ingredient in Mounjaro and Zepbound—from the U.S. market. This revelation prompted us to investigate, leading us to a recently discovered FDA submission, dated August 28, 2024, in which Eli Lilly petitioned the agency to designate tirzepatide as a “demonstrably difficult to compound” (DDC) drug. If approved, this designation could effectively end the legal availability of compounded tirzepatide, forcing patients to rely exclusively on brand-name options.
Eli Lilly’s petition is not the only route they’ve pursued in this campaign. In a strategic move, they previously reported to the FDA that tirzepatide is now commercially available, advocating for its removal from the FDA’s drug shortage list. This action led to the FDA officially removing tirzepatide from the shortage list just weeks ago, further jeopardizing access to compounded versions. The shortage status had been a critical factor enabling compounding facilities to legally produce tirzepatide, which is otherwise protected by patents. The removal sparked a legal clash, as the Outsourcing Facilities Association (OFA) filed for an emergency injunction against the FDA’s decision, arguing that Eli Lilly’s approach disregards patient need amid the ongoing high demand and accessibility issues.
The Growing Effort to Block Compounded Tirzepatide
This campaign by Eli Lilly echoes Novo Nordisk’s recent efforts to prevent compounded semaglutide, highlighting a push by major pharmaceutical companies to eliminate compounded alternatives to their GLP-1 medications. For patients who rely on compounded tirzepatide—especially amid cost concerns and insurance complexities—this series of actions could severely impact access.
Eli Lilly’s Case for Restricted Compounding
Eli Lilly’s August petition presents several arguments to justify adding tirzepatide to the DDC list, emphasizing its complex chemistry and critical role in patient safety:
Molecular Complexity: Lilly’s primary argument hinges on tirzepatide’s structure as a dual-action GIP and GLP-1 receptor agonist. According to their submission, the unique macromolecule is challenging to replicate with precision, raising questions about the safety and efficacy of compounded versions.
Concerns Over Dosing and Purity: Lilly argues that compounding tirzepatide may lead to significant dosing inconsistencies, as compounded versions may not achieve the exact potency and purity required. Misalignment in dosage could lead to patient risks, particularly for those managing chronic conditions like obesity and type 2 diabetes.
Legal Considerations: Eli Lilly’s actions around tirzepatide’s availability signal a multi-layered approach to protect their patented product from compounded alternatives. By reporting tirzepatide as commercially available, Lilly has strategically influenced its FDA listing, effectively narrowing legal compounding options.
FDA’s Process and Legal Battle
The petition marks only the beginning of a potentially lengthy FDA review process:
Public Comment Period: Patients, healthcare providers, and advocacy groups will have 60-90 days to submit comments, raising awareness and potentially impacting the FDA’s evaluation. This can be found here.
FDA Advisory Committee Review: The Pharmacy Compounding Advisory Committee may be convened to assess the scientific, safety, and patient-centered arguments. Depending on the complexity, this step could extend for months.
FDA Decision and Rulemaking: After collecting data and comments, the FDA will make its decision, which could take six months to a year. While this timeline allows some breathing room, patients should consider alternatives now.
What Comes Next for Compound Tirzepatide Patients?
For those currently using compounded tirzepatide, now is the time to consider all available options. Pursuing prior authorizations for branded versions of these medications may be worth another look, and telehealth providers like Ro (our official OTP telehealth partner), which specialize in navigating complex insurance requirements, could increase the chances of approval. Many telehealth providers like Ro work on thousands of prior authorizations and have an edge on primary care providers in their familiarity of the complexities of the process, as well as the internal bandwidth to commit the necessary time to filing successfully.
The Larger Picture: A Shift Against Compounded Medications
Eli Lilly and Novo Nordisk's actions point to an evolving landscape where major pharmaceutical companies aim to curb the availability of compounded versions of their medications, citing safety, efficacy, and purity concerns. As with Novo Nordisk’s approach toward semaglutide, Eli Lilly’s actions may set a precedent that could impact the future of compounding as a practice in the U.S.
Stay informed by following On The Pen for ongoing coverage, analysis, and action steps. The petition marks a crucial moment for the compounding community, with significant implications for patient access and advocacy.
Stay informed by following On The Pen for ongoing coverage, analysis, and action steps. The petition marks a crucial moment for the compounding community, with significant implications for patient access and advocacy.
UPDATE: 10/25/25 1:59 p.m. Central
A statement from Eli Lilly on the request to add tirzepatide to the D.D.C. List:
In August, Lilly requested that tirzepatide be added to FDA’s Demonstrable Difficulties for Compounding (DDC) list. Our request to FDA includes data demonstrating tirzepatide meets the DDC list inclusion criteria because tirzepatide is a complex macromolecule that is inherently challenging to safely compound. Safe manufacture of tirzepatide also requires complex physiochemical and analytical testing—which compounding pharmacies typically can’t or don’t run—to control for biologically active impurities and ensure a safe and effective finished product. In short, compounded tirzepatide presents significant patient safety concerns. Lilly’s request – which was filed on a public docket – remains pending with FDA.