The FDA has classified BPC-157 in Category 2 for bulk drug substances, citing possible safety issues in compounding, such as immunogenicity, impurities, and insufficient safety evidence for suggested administration routes
And this is what gave rise to the idea that perhaps some of the peptides that are secreted from the thymus, such as thymus and beta-4, could be involved in tissue rejuvenation and repair
The FDA specifically warned about peptide-related impurities and API characterization problems in other words, that whats in the vial might not be 100% pure BPC-157, and even if it is, the peptide could degrade or contain variants
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