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We further disagree that the proposed requirements are duplicative of the certification requirement at 180.70(a)(2)(iv) as our stated goal for adding the attester name was to provide further reassurance to the public of the accuracy and completeness of the MRF, while the certification requirement is provided directly and only to CMS under the compliance process

Legitimate prescriptions should include appropriate pharmacy labeling, patient-specific information, dosing instructions, and prescribing clinician information

However, they are all in use experimentally off- label, as none of them have been approved

Cell 173 , 7489.e20 (2018)