The legal landscape surrounding compounded tirzepatide has experienced a significant shift. On March 5, 2025, Judge Mark Pittman denied the preliminary injunction sought by the Outsourcing Facilities Association (OFA) in its lawsuit against the U.S. Food and Drug Administration (FDA). This sealed decision permits the FDA to commence enforcement actions against pharmacies compounding tirzepatide.
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FDA Enforcement Deadlines
The FDA had previously outlined specific timelines for ceasing compounded tirzepatide production:
State-Licensed Pharmacies (Section 503A): Required to halt compounding, distribution, or dispensing of tirzepatide injections by February 18, 2025, or upon the court's decision on the preliminary injunction, whichever was later.
Outsourcing Facilities (Section 503B): Permitted to continue operations until March 19, 2025, or until the court's decision, whichever was later.
With the injunction denied, these deadlines are now in effect, and the FDA is poised to enforce compliance.
Direct-to-Consumer Initiatives by Novo Nordisk and Eli Lilly
In response to the evolving market dynamics and to provide affordable options for patients, both Novo Nordisk and Eli Lilly have launched direct-to-consumer programs:
Novo Nordisk's NovoCare Pharmacy: Introduced on March 5, 2025, this program offers all doses of the FDA-approved weight-loss drug Wegovy (semaglutide) at a reduced cost of $499 per month. The service provides convenient home delivery for cash-paying patients, aiming to make authentic medication more accessible. citeturn0search0
Eli Lilly's LillyDirect: Launched in January 2024, LillyDirect recently expanded to include higher-dose vials of Zepbound (tirzepatide). As of February 25, 2025, 5 mg, 7.5 mg and 10 mg vials are available at $499 per month for self-paying patients. This initiative seeks to offer a reliable source of FDA-approved medication directly to consumers.
Implications for Semaglutide Litigation
Judge Pittman is also presiding over a similar case brought against the FDA by the OFA involving semaglutide, the active ingredient in medications like Ozempic and Wegovy. His handling of the tirzepatide case may offer insights into the potential trajectory of the semaglutide litigation. Notably, Novo Nordisk, the manufacturer of semaglutide products, initially faced procedural hurdles in joining the lawsuit but has since been granted intervention.
Industry Response and Patient Impact
The denial of the injunction represents a significant setback for compounding pharmacies and patients relying on the often more affordable compounded tirzepatide alternatives. Many telehealth companies have offered their patient assurances that compounded GLP-1 medications would continue to be prescribed and fulfilled using the 503a loophole that offers custom dosing and custom formulations not available in branded forms. Time will tell whether this strategy holds up in the face of inevitable pushback from the drug companies, and possibly the FDA itself. As enforcement looms, access to compounded versions will diminish, potentially leading to increased costs and limited availability for patients.
However, the direct-to-consumer programs introduced by Novo Nordisk and Eli Lilly aim to bridge this gap by providing authentic, FDA-approved medications at more accessible price points. These initiatives may mitigate some of the challenges faced by patients transitioning from compounded to branded treatments.
The outcome of the semaglutide case now carries heightened significance, as it may further define the FDA's authority over compounded medications and impact patient access to essential treatments.