FDA Proposes Rule to Require Electronic Rx Drug Labels

An FDA draft rule would require pharmaceutical manufacturers to distribute prescribing data for healthcare professionals electronically. “FDA is taking this action to ensure that the most current prescribing information for prescription drugs will be available and readily accessible to healthcare professionals at the time of clinical decision making and dispensing,” the agency stated. The electronic distribution requirements of this proposed rule would not apply to patient labeling (including patient package inserts and Medication Guides), or to prescribing information accompanying promotional labeling, which would continue to be provided in paper form. Comments on the proposed rule, identified by Docket No. FDA-2007-N-0363, are due March 18, 2015.