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The clinical need must be considered in addition to any potential adverse outcomes for the infant

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TMAO not only induces endothelial dysfunction but also acts on various cell types, such as endothelial cells, epithelial cells, vascular smooth muscle cells, nerve cells, and pancreatic cells, triggering multiple cell death mechanisms, including necrosis and programmed cell death, thereby influencing host health

The FDA's 2022 guidance on bulk drug substances explicitly named BPC-157 as a compound that does not meet the criteria for inclusion in compounded drug preparations under Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act