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An error in any one of those three elements can trigger an automatic claim denial before a human reviewer ever sees the claim

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

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