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Under Section 503A of the Federal Food, Drug, and Cosmetic Act, licensed pharmacies can compound medications based on individual prescriptions from licensed practitioners
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The amino acid sequence is the same compound that Eli Lilly has published, but the research-grade material supplied here is not equivalent to Eli Lilly's investigational drug product, is not produced under the same regulatory framework, and is not a substitute for any clinical trial supply, compounded preparation, or future approved formulation
Additionally, factors such as cost, accessibility, and varying insurance coverage in different parts of the world pose potential barriers to widespread adoption
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