What is structured product labeling?

Structured Product Labeling (SPL) is a standardized method for describing the content and format of product information. It was developed by the U.S. Food and Drug Administration (FDA) in collaboration with other organizations such as Health Level Seven International (HL7), the National Library of Medicine (NLM), and the Drug Information Association (DIA).

SPL allows for the consistent and uniform exchange of product information between manufacturers, regulators, and other stakeholders in the healthcare industry. It is primarily used for prescription drugs, biologics, and certain over-the-counter medications.

Key features of SPL include:

1. Standardized format: SPL uses Extensible Markup Language (XML) to describe the structure and content of product information. This enables the data to be easily processed, shared, and displayed across different systems and platforms.

2. Structured content: SPL provides a predefined set of data elements and attributes to organize and represent product information. This ensures consistency and facilitates automated processing of data.

3. Hierarchical structure: Product information in SPL is organized into sections, subsections, and components, allowing for the logical grouping of data. This improves the clarity and accessibility of the information.

4. Controlled terminology: SPL uses standardized terminology from various coding systems, such as the FDA's National Drug Code (NDC) directory and the Unified Medical Language System (UMLS). This ensures consistent and accurate representation of product information.

5. Product labeling updates: SPL allows for the efficient updating of product labeling information. Manufacturers can submit updated data electronically, enabling regulators and other stakeholders to access the most current information in a timely manner.

6. Regulatory compliance: SPL is an essential component of regulatory submissions and compliance for pharmaceutical products. It facilitates the electronic submission of labeling information to regulatory authorities, streamlining the review and approval processes.

Overall, structured product labeling improves the efficiency, accuracy, and consistency of product information exchange in the healthcare industry. It enhances patient safety by ensuring that healthcare professionals and consumers have access to up-to-date and standardized information about medications.