Current Edition

The Future of the Drug Label: FDA’s Proposed Rule on Electronic Distribution of Prescribing Information

Prescription labeling is currently distributed in paper form on or within the package of a prescription drug or biological product when it is dispensed. In a proposed rule, announced in the Federal Register on December 18, 2014, the US Food and Drug Administration (FDA) states its intention to require electronic distribution of the prescribing information for health care professionals. When the proposed rule is finalized, the paper form will no longer be permitted. As with many regulatory actions, however, any exceptions would be listed. Regina Ballinger, Senior Manager of Regulatory Intelligence with Thomson Reuters gives us an insight into the future of drug label.….pdf