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The Regulatory Reality of 2026: What Actually Changed In late 2023, the FDA moved 19 peptides, including BPC-157, to what's known as "Category 2" status under its framework for bulk drug substances used in compounding, identifying them as substances that "may present significant safety risks." The concern, as stated in FDA guidance, centered on the limited large-scale human data and questions about immunogenicity

The tool followed the decision tree in Supplementary Fig

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