Managing product information is quite a task. In the stringent world of life sciences, to do so, manufacturers must follow certain standards and procedures which are aligned to FDA’s regulations. Not only do they have to follow the set procedures but they are also required to maintain accuracy and integrity of information to be prescribed for an end-to-end compliance.

With so many stakeholders, namely, patients, physicians and pharmacists relying on the prescribed information there might be a chance for significant discrepancies. There arises a need for developing uniform labeling content. Consistently revising the content and formats of the prescribing information, the US FDA adopted a set standard called Structured Product Labeling (SPL) to assist in greater patient safety and increased usability of product information.

What exactly is Structured Product Labeling (SPL)?

Structured Product Labeling (SPL) is a Health Level Seven International standard (a standards development organization accredited by the (ANSI) American National Standards Institute) which defines the content of human prescription drug labeling in an Extensible Markup Language (XML) format.

The new format not only enables health care professionals to quickly search and access specific prescribing information and reduces medication errors in turn, but also supports initiatives to improve patient care through electronic prescribing and improves the drug labeling review process enabling FDA to provide immediate access to the most recent drug information.

SPL documents primarily consist of two main components.

  • first, the content of labeling that include all texts, tables and figures for a product
  • second, the additional machine readable information constituting the drug listing data elements such as product ingredients, generic names, dosage forms, routes of administration, appearance and packaging quantity and type

Challenges & Solution

Product labeling in life sciences, is a highly regulated and complex process. Not only should it be extremely specific in its content, but also it should comply with country-specific labeling regulations. Structured Product Labels (SPLs) may be a small component of eCTD submissions, but it can be quite a task for an organization’s Regulatory team if the technical specifications and time requirements are not well grasped and followed. Without working knowledge of how extensible markup language (XML) works, it is highly probable that an organization would encounter several technical issues and spend considerably more time and energy. Consult an industry expert, familiar with the intricacies of XML to avoid an SPL rejection, and ensure error-free and timely implementation of FDA submissions.


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