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Ipamorelin, as a peptide, has been subject to evolving FDA policy discussions regarding Category 1 and Category 2 503A classification, though its current status places it outside the list of office-compoundable bulk drug substances without an active investigational new drug application

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However, hydroxyurea can have a further significant impact on sperm production as well, with studies showing 86% of men decreasing total sperm counts at 6 months

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