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Formal inclusion means the FDA has determined, after applying its statutory and regulatory process, that a specified bulk drug substance can be used under the section 503A bulks-list pathway when all other conditions are met

The FDA has also flagged BPC-157 in the context of bulk substances that may pose significant safety risks, especially in compounding environments

(1998) Effects of low-dose recombinant human insulin-like growth factor-I on insulin sensitivity, growth hormone and glucagon levels in young adults with insulin-dependent diabetes mellitus