Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products; Extension of Comment Period

The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of December 18, 2014. In the proposed rule, FDA requested comments on its proposal to amend its labeling regulations for human prescription drugs and biological products to require that the prescribing information intended for health care professionals that is on or within the package from which the product is dispensed be distributed electronically and not in paper form, except as provided by the proposed rule. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.