FDA continues SPL standard rollout

The FDA is continuing its rollout of the structured product labeling (SPL) standard. The regulator is working on release 5 of the XML-based electronic labeling standard, which adds specs for medical devices to the existing base of drug products.

According to Lonnie Smith of the FDA's Office of Critical Path Programs, the update will have no impact on current users. Smith spoke before roughly 120 attendees at last week's DIA annual meeting in Washington, D.C.

The FDA's embrace of SPL, which is approved by the Health Level 7 (HL7) committee, stems from its indexing abilities. "PDF gave you blocks of text, but you couldn't get in and pull out data," says Smith. "SPL lets you do that."

SPL provides also for indexing through the insertion of machine-readable tags that don't appear on label content. Indexing lets users search and sort product information, while providing support for automated health information systems and e-prescribing. In addition, the labeling standard is compatible with the National Library of Medicine's product-identification system, which allows users to click on an image of a drug or package and then link to label information.

CDER has been using SPL for four years, while CBER has been using it for a year and a half, says Smith. SPL-to-PDF conversion programs, and SPL-to-Word and -html, are available.