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Prescribing an unapproved drug: Is not protected by the established legal framework for off-label prescribing Exposes the prescribing physician to malpractice liability, since they cannot point to FDA-reviewed safety and efficacy data May constitute a violation of state medical practice acts, depending on jurisdiction Creates liability exposure for the prescribing clinic if adverse events occur Providers who encounter clinics or telehealth platforms offering AHK-Cu prescriptions should understand that those prescriptions are not operating within a standard legal framework