FDA Issues Proposed Rule to Require Electronic Distribution of Prescribing Information

December 31, 2014

Food and Drug Administration has released proposed rules to amend its prescription drug and biological labeling regulations to require electronic distribution of the prescribing information intended for health care providers.

Food and Drug Administration (FDA) has released

proposed rules

(PDF) to amend its prescription drug and biological labeling regulations to require electronic distribution of the prescribing information intended for health care providers. Currently, this information is distributed in paper form on or within a package from which a product is dispensed, but under the proposed rule, paper distribution would no longer be allowed. The electronic distribution requirements do not apply to patient labeling or to prescribing information accompanying promotional labeling, which would continue to be provided in paper form. FDA is accepting comments on the proposed rule until March 18, 2015. Additional details, including the proposed rule, are available on the

Federal Register

website.