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The FDA has stated clearly that compounded drugs "are not FDA-approved and have not been reviewed for safety, efficacy, or quality" [3]

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This trend is associated with substantial increases in morbidity and mortality, driven by complications including type 2 diabetes (T2D), metabolic dysfunction-associated steatotic liver disease (MASLD), and cardiovascular disease

Both BPC-157 and TB-500 are research chemicals intended for laboratory and preclinical investigation only, and neither is approved by the FDA or any major regulatory agency

28, 29 Other mediators, such as histamine, can have both positive and negative immunomodulatory effects