Structured Product Labeling

Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by U.S. Food and Drug Administration (FDA) for the exchange of product and facility information. It is a part of the Health Level Seven standards which are widely used in healthcare to exchange clinical and administrative data.

Overview

Structured Product Labeling (SPL) is a form of Extensible Markup Language (XML) that is used to standardize the information on labels of prescription drugs and biological products. The SPL standard allows for the exchange of information in a consistent manner, ensuring that all parties involved in the manufacturing, distribution, and regulation of a product have access to the same information.

Components

The SPL document consists of several components, including the product information, package insert, medication guide, and patient package insert. Each of these components provides specific information about the product, such as its ingredients, usage instructions, warnings, and other relevant data.

Benefits

The use of SPL has several benefits. It allows for the efficient exchange of information between different parties involved in the product lifecycle. It also ensures that the information is presented in a consistent and standardized format, which can help to reduce errors and misunderstandings. Furthermore, it allows for the integration of product information into electronic systems, which can improve the efficiency of processes such as product ordering and inventory management.

Implementation

The implementation of SPL requires the use of specific software tools that can generate and validate SPL documents. These tools must be compliant with the HL7 standards and the FDA's requirements for SPL. The FDA provides a list of SPL software that is compliant with its requirements.

See also

• Health Level Seven International (HL7)
• Extensible Markup Language (XML)
• U.S. Food and Drug Administration (FDA)