What is Structured Product Labeling (SPL)?
SPL is an electronic document markup standard for prescribing information that specifies the structure and semantics for the regulatory requirements and content of product labeling and has been adopted by the FDA as a mechanism for exchanging medication information. The FDA adopted technology for exchanging information between computer systems based on Clinical Document Architecture (CDA). CDA was developed by Health Level Seven (HL7), a standards development organization. CDA allows information to be exchanged in extensible markup language (XML) and is the standard for the electronic health record. SPL was developed collaboratively by the HL7 Clinical Document Architecture work group. SPL assists with the provision of product labeling content both electronically and in human readable format, thus allowing the exchange of information between computer systems, improving access to information, and enhancing the ability to query and report on labeling content. The FDA currently requires d
