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it has been used topically for decades without serious adverse events, and injectable formulations in animal models show no organ toxicity at doses up to 50 mg/kg" [8]

But, while berberine may influence glucose and insulin regulation, it works differently than prescription medications and should not be viewed as a replacement

For example: FDA communications indicate AOD-9604 was removed from Category 2 in 2024 because nominations were withdrawn, while also noting FDA would consult the Pharmacy Compounding Advisory Committee (PCAC) about potential inclusion on the 503A bulks list

doi: 10.1002/hbm.70180 62