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### How the Legal Landscape May Change The peptide regulatory environment has been in flux since the FDA's 2019 and 2020 guidance documents on bulk drug substances

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(Paw and Shulman 2025) [1c] levetiracetam: dosing Loading dose in status epilepticus : 60 mg/kg up to a max of 4.5 grams, infused over 10 min