United States: The pharmaceutical company Eli Lilly launched legal actions against two medical facilities that produce Zepbound and Mounjaro through compounding because these businesses defy the Food and Drug Administration’s limitations on medical preparation while drawing patients from Lilly’s approved medications.
Legal Action Against Pharmacies
Lilly submitted two lawsuits on Tuesday in Delaware and New Jersey, which charged Strive Pharmacy and Empower Pharmacy with the false promotion of their products as individualized versions of drugs that underwent clinical trials and met standardized safety requirements.
Several claims presented by Lilly indicate people move toward compounded drugs instead of accepting FDA-approved treatments.
The companies Strive Pharmacy and Empower Pharmacy did not provide any response when CNBC requested comments.
FDA Regulations and Compounding Practices
The FDA established last month that both compounding pharmacies and outsourcing facilities should stop creating their versions of tirzepatide because the brand-name products appeared out of shortage.
Some facilities have continued to compound medications by altering dosage levels and vitamin combinations, which enables them to work outside of the FDA ban against Lilly’s drugs.
Strive and Empower function as mass production facilities to make modified versions of tirzepatide that do not qualify as personalized medications, according to Lilly.
Large-scale compounding of branded drugs becomes possible during shortages of those specific products.
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Special versions of medication exist for such unique personal needs as when patients suffer from ingredient allergies or require drugs in distinct dosage formats compared to existing commercial versions.
The companies Strive and Empower deliver tirzepatide through major telehealth providers, Lavender Sky Health and Mochi Health.
The mentioned companies failed to answer CNBC’s inquiries about their business activities.
Lilly faces its first judicial challenge against compounding pharmacies while having removed Zepbound and Mounjaro from the FDA’s shortage list.