Structured Product Labeling (SPL) is a standard document approved and issued by Health Level Seven (HL7) to exchange information related to product and facility. It is used as a base for Regulatory guidance document in exchange for product labeling content. SPL ensures control over critical product information that has led to a standard for product labeling. It is adopted by the Food and Drug Administration (FDA) to ensure patient safety and increase product usability among its consumer base. In 2005, the FDA has mandated the use of XML which is compliant with SPL standard for electronic submissions. It defines the content and structure of product labeling, which is required to be submitted to FDA. The use of consistent structure and standard terminology is to improve the integrity of the product information.

General Requirements for SPL

  • New and existing labeling content should be converted into XML format
  • Narrative labeling content and drug listing information should be submitted to the FDA
  • Consistent product information should be maintained across all package, label, and promotional outputs

Goals of SPL

  • Timely and accurate availability of product labeling information 
  • Review, storage, and distribution of labeling content 
  • Ensured human readability and machine processing for labeling content

Benefits of SPL

One of the primary reasons for implementing SPL is to ensure a uniform approach to the labeling content. With the use of a structured format, improvements can be made to the entire manufacturing and labeling process by health authorities and industries. This will benefit the consumers by:

  • Improving patient safety with accurate and consistent product information
  • Providing readily available content for both consumers and management systems
  • Reducing manual effort in terms of review and approval of labeling content
  • Maintaining a standard format across labeling content such as ingredient names, package types, dosage forms, and routes of administration

How compliant is your organization with SPL guidelines? Contact our Regulatory labeling experts to know more. Reach us at