In December, 2003, FDA published final regulations requiring the submission of the content of labeling in electronic format for marketing applications. This became known as the Electronic Labeling Rule and became effective on June 8, 2004. The regulations for initial submissions for NDAs, ANDAs, and BLAs and annual reports to marketing applications specified that the content of labeling must be submitted electronically in a form that FDA can process, review, and archive.

To support these regulations and additional initiatives, the Agency adopted a new technology for exchanging information between computer systems based on standards developed by Health Level Seven (HL7). This technology allows information to be exchanged in extensible markup language (XML). The HL7 standard was called Structured Product Labeling (or SPL). SPL was officially adopted as the only acceptable format in October, 2005.

The SPL program has evolved under the umbrella of the DailyMed Initiative, which is a partnership between the FDA, National Library of Medicine, and healthcare information suppliers. The goal of this initiative is to enhance patient safety through accessible medication information.