The Five-Gate Framework: A Two-Axis Evidence-Governance Instrument for Peptide Therapeutics in Pre-Consensus Use. Specification, Calibration on an Approved Anchor, and an Applied Monograph on BPC-157

Version 1. Self-published; not yet peer reviewed. Nick Stanley, BSc, NMD. Licensed naturopathic physician, State of Idaho.Independent researcher. Some compounds are used as medicines before approval, before guidelineconsensus, and before any lawful supply exists. This paper specifies aframework that records four answers separately for every specific claim:how strong the evidence is, whether there is a justified case for action,what level of clinical engagement the evidence supports, and whether alawful product exists. It is calibrated on tirzepatide, an approved drug,then applied to BPC-157, which has none of the three. For BPC-157: seven claims graded from 70 evidence units across 23 studies,one declined. All six therapeutic claims were Tier 3, not warranted, withno lawful source. A supply-side regulatory change during the study alteredno evidence-side value. The outputs authorize nothing; each record stateswhat evidence would change it. Deposit: manuscript (PDF, DOCX), figures, and supplementary files S1 to S25,including the specification v3.2, record schema v1.2, validator v2.5,disposition records, evidence-unit table, study registry, and a SHA-256manifest. Documents, figures, and data are CC BY 4.0. Code files are MIT.