Urupês court suspends municipal compounded tirzepatide program

A court in São Paulo has ordered the municipality of Urupês to suspend its program providing compounded tirzepatide for obesity treatment. The decision follows a legal challenge by pharmaceutical companies Eli Lilly do Brasil and Eli Lilly and Company, the manufacturers of the industrial medication Mounjaro.

The program, which served approximately 400 patients using funds from a federal parliamentary amendment, utilized compounded versions of the active ingredient rather than the registered industrial product. Eli Lilly argued that the municipality was engaging in large-scale production through compounding pharmacies, which violates sanitary regulations. The companies stated that compounding should only occur for specific, individualized patient needs with technical justification, rather than as a systematic alternative to registered medications.

Judge Patrícia da Conceição Santos ruled that the systematic production of magistral preparations does not meet sanitary requirements for individualized treatment. The court found insufficient evidence that the medication was prepared for specific patients rather than being acquired in standardized quantities. The injunction also prohibits the administration from issuing new supply orders or accrediting pharmacies for the substance. A daily fine of R$ 10,000 has been established for non-compliance.