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Why this matters Relying solely on metformin is like turning off the fire alarm without putting out the fire
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The 503A Bulks List is the mechanism that allows this kind of compounding, and a substance only lands on it after a full sequence: nomination, a PCAC recommendation like this one, a comment period, then formal rulemaking through the Federal Register
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FDA Regulatory Status and Off-Label Context GHK-Cu has no FDA approval as a drug for any indication
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