FDA Proposes Electronic RX Labeling Rule

By Katie Wike, contributing writer

Rather than paper prescription drug labels, the FDA has proposed an electronic system for providers.

Paper prescription labels may soon be replaced with an electronic alternative when a newly proposed FDA rule goes through. iHealth Beat reports the proposal would require drug makers to:

• send FDA prescribing data when labeling information changes so the agency can update its public labeling website
• review and verify information on the site is correct
• notify FDA promptly if information on the site is incorrect

According to the Federal Register, the FDA is “proposing to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for healthcare professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed.”

“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,” said the agency, according to Bloomberg BNA.

The law would also require containers and packages to include language directing prescribers to FDA's labeling site to view prescribing information. It would also a toll-free phone number, accessible 24/7, at which the drug manufacturer can receive requests for paper copies of prescribing information. It would not, however, change the labels and printed drug information consumers rely on for instructions.

The FDA estimates that the change to electronic labeling would save the drug industry between $52 million and $164 million.