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Prescribing unapproved drugs is not routine medical practice Without FDA approval or an authorized investigational pathway, licensed providers do not have authority to prescribe experimental compounds as treatment

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The physician writes the prescription after a consultation, an FDA-registered compounding pharmacy prepares the formulation, and the patient receives clear guidance on application protocol and realistic expectations

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Non approvato come farmaco da FDA, EMA o altre agenzie regolatorie, e la quasi totalit dei dati disponibili proviene da modelli animali