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Electronic Distribution of Prescribing Information for Human Prescriptions Drugs, Including Biological Products (Proposed Rule)

Summary

The Food and Drug Administration is proposing to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed. FDA is also proposing that prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed, except as provided by this regulation. We are proposing these actions to help ensure that the most current prescribing information is publicly accessible for the safe and effective use of human prescription drugs.

Regulatory Impact Analysis

Electronic Distribution of Prescribing Information for Human Prescriptions Drugs, Including Biological Products (Proposed Rule)

Federal Register: 79 FR 75506, December 18, 2014

Docket: FDA-2007-N-0363-0040