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The FDAโs stated reason for the original Category 2 placement is worth quoting exactly, because it is not what most people assume: compounded injectable drugs containing GHK-Cu โmay pose risk for immunogenicity due to the potential for aggregation and peptide-related impurities,โ and โthere are limited data in humans to inform safety-related considerations.โ The concern on record is immunogenicity and impurities, not copper toxicity
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