Structured product labeling (SPL) is a specific form of document markup standard, which has been approved by Health Level Seven (HL7). It is used by the FDA for the exchange of product and facility information.
Structured Product Labeling
SPL is used for the labeling of human prescription drugs & exchange of information about medical devices and is presented in an XML format. The SPL schema—displayed within a SPL stylesheet—contains the required labeling content (such as figures, text and tables,) as well as information that is readable by machine (such as, ingredients, generic names, ingredient strengths, dosages, DEA schedule, and routes of administration). All labeling submissions to the FDA’s Center for Drug Evaluation and Research have been required to meet SPL format since October 31, 2005. The current SPL working group has a number of objectives, including:
- raising awareness of SPL throughout the industry
- sponsoring meetings and webcasts related to the industry
- providing a forum for FDA documentation of SPL, best practices, and discussion of issues
- reviewing changes to XSL stylesheet
- reviewing changes to HL7 SPL model
- determining future standards
Health Level Seven
Health Level 7 refers to a set of international health standards devised by Health Level Seven International. The non-profit organization was founded in 1987, to provide an extensive set of standards for the integration, exchange and retrieval of electronic health information, and is designed to provide support for clinical practices and health care services. The standards cover a number of areas including:
- electronic health records
- personal health records
- rules syntax
- decision support
- data and messaging exchange
- insurance claims
- visual integration of applications
- clinical documents
- Prescription medication labels
Innovatum delivers technologies known as ROBAR Master Data Management and ROBAR Communication Manager. Together these products convert Medical Device UDI attribute information into HL7 SPL and upload it to the FDA GUDID. Contact Innovatum for more information.
