FDA SPL - Structured Product & Drug Labeling Composition Process

Capitalize on your investment in Structured Product Labeling. Increase accuracy while reducing risk and saving time and money.
composition documents

SPL – XML Format Publishing Composition

Gain increased control

Create print and web-ready files directly from structured product labeling. Reed Tech offers a process to use the Content of Labeling portion of the FDA-accepted SPL Drug Listing file as the source for:

  • Manufacturing Package Insert (PI)
  • Med Guide
  • Patient Package Insert (PPI)
  • Product Web Pages

Structured Product Labeling (SPL) is a Health Level Seven (HL7) International standard for regulatory guidance documents as a method for communicating product and facility information. Accepted by the Food and Drug Administration, structured product labeling enhances the cohesiveness and honesty of product information because it requires reliable structure and standardized terminology. SPL documents consist of not only the content of labeling (text, figures, and tables) but also information about the product (drug listing data elements) that is readable by machines.

The Food and Drug Administration requires that drug manufacturers and distributors submit detailed documentation about each of their drug products. Structured product labeling for both prescription and over-the-counter (OTC) drugs must incorporate an overview of the scientific information needed for the correct and effective use of the drug. The labeling is broken up into sections including explanations for use (prescription drugs) or purpose (OTC drugs), adverse effects, and more.

The SPL specification was created to assure that there was a consistent way to develop drug labeling content. By using an established method for product labeling, enhancements and improvements can be attained throughout every step of the labeling process, from the creation to the distribution of labeling content by industry and health authorities. The labeling of drug products is a crucial part of product life cycle management.

The procedure of product labeling is detailed, complicated, and closely monitored. The content that the product label contains is very precise, especially regarding its safety data and adverse effects. Let our SPL-Driven Composition Process ease your procedures for Structured Product Labeling today.

    Learn more about Structured Product Labeling Solutions & Services for Rx, OTC and Biologics