SPL is a document markup standard approved by HL7 and adopted by FDA as the standard format for electronic submission of the content of labeling. It also carries drug establishment registration and listing information. The labeling in an SPL file is published on DailyMed, the National Library of Medicine's repository of current drug labels. Every NDC in a listing appears in SPL.

Why it matters for labeling

The text in an SPL file has to match the FDA-approved labeling exactly, and because the file is published and reused by pharmacies and drug databases, an error spreads well beyond one printed label. SPL is usually produced by converting text from another format, which can introduce encoding errors and hidden characters that structural validation doesn't catch.

Common mistakes

  • Checking that the file is well-formed but not that the words match the approved labeling
  • Errors introduced when converting from PDF or Word to XML
  • Not rechecking the SPL after a safety update or a change to the NDC format
  • Carton and container text in the SPL differing from the printed labels

Sources