FDA to drug makers: Submit labels electronically

07.11.2005

As the FDA receives the SPL-formatted labeling information, it will become available, free of charge, via the Web.

Drug manufacturers, technologists and the FDA worked together to develop the SPL standard, according to FDA spokeswoman Karen Mahoney.

"Industry has been having minor problems coding more complicated labeling situations," Mahoney said. "However, we are expecting that these will be sorted out quickly. The FDA has been advising industry in these situations."

The new electronic product labels will be the primary source of medication information for DailyMed, a new, free, interagency online health information clearinghouse for consumers, health care providers and health care information providers, the FDA said.

Within one year, product labels for most approved prescription medications will be posted on DailyMed, according to the FDA.