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Both BPC-157 and TB-500 are research chemicals intended for laboratory and preclinical investigation only, and neither is approved by the FDA or any major regulatory agency

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Note on humans: These benefits are not established in humans the evidence is mostly older Russian and preclinical work with limited independent replication [13]

The FDA applied a four-part statutory test under 21 CFR 216.23(c): physical and chemical characterization, historical compounding use, evidence of effectiveness, and safety