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In 2023, the FDA designated BPC-157 as a Category 2 bulk drug substance, i.e., its evidence to establish safety for human use is currently insufficient

[DOI] [PubMed] [Google Scholar] 177.Ouyang N, Yang C, Li X, Zheng Z, Xu Y, Wang Y, Xiong W, Wu H

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This is precisely why its the gold standard for reconstituting medications or peptides that will be used more than once from the same vial

Subcutaneous injection and oral capsules, the two most common human routes, have not been studied with the same rigor in animals

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