Structure Product Labeling, SPL Submissions, HL7 SPL, FDA

As per the United States Food and Drug Administration (USFDA) norms, adopting technology, its processing, managing, labeling and details of any label changes made, including change in content of the formatted label, carton labeling or container labeling have to be electronically submitted using Structured Product Labeling (SPL) standard.

Based on extensible markup language (XML) the SPL facilitates the communication of drug labeling data reliability among various groups such as the FDA, hospitals, prescribing organizations, and doctors, in addition to the general public through the DailyMed.

Structured Product Labeling (SPL) is a Health Level Seven (HL7) standard based on Clinical Document Architecture and HL7 Reference Information Model (RIM) accredited by the American National Standards Institute (ANSI) for the exchange of product information. SPL documents include a header and body. The header includes information about the document such as the type of product, its author and details about its versioning. The body of the document includes product information in both structured text and data element formats. The FDA uses SPL documents to exchange information elaborating various product related topics.

To assist organizations, Freyr integrates a web-based tool that automates compliance with current SPL and PLR standards as established by the FDA. With an experienced team of conversion specialists and a unique SPL conversion methodology, Freyr ensures accurate label conversion and 100% compliance.