Section 1e: Version 3 (V3)
Section 2: Clinical and Administrative Domains
Section 3: Implementation Guides
HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 3: FDA Content of Labeling
This document provides technical conformance criteria for Structured Product Labeling (SPL) files based on the drug establishment registration and drug listing process at the United States Food and Drug Administration (FDA). Information on electronic submission may be found in guidance entitled Providing Regulatory Submissions in Electronic Format – Establishment Registration and Drug Listing. This document provides links to additional reference material. A link to the latest SPL schema and controlled terminology used in SPL and other technical documents and examples may be found on the FDA Data Standards Council web site at: www.fda.gov/oc/datacouncil/spl.html. Outside the scope of this document is information on the creation of SPL for a specific product and instructions on the use of extensible mark up language (XML).
HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 3: FDA Content of Labeling may also go by the following names or acronyms:
- Pharmaceutical Companies
- Veterinary Drug Product Companies
- Biologic Drug Companies
- Producers of Bulk Drug Products
- Facilitates provision of the content of product labeling both electronically and in a human readable format. SPL documents can be exchanged across systems without the need for additional transformation steps.
- Improves dissemination of product labeling (both new product labeling and product labeling updates) to users of product labeling. The ability to provide the most up-to-date product labeling in a timely manner is considered to be critical to improving risk management of regulated products.
- Facilitates more efficient evaluation of labeling changes by allowing more effective use of computer technology to compare different versions of labeling on a section by section basis.
- Promotes more coordinated data collection throughout the regulatory agency and improve processing, storage and archiving capabilities. Reduce or eliminate redundancies in data collection.
- Improves access to information and enhance the ability to query and report on the content of labeling, allowing better support for specific analyses such as sub-population assessments of differences in products based on gender, race, age, and geographic location.
- Improves interoperability of the regulatory agency's systems with other clinical information systems
- Uses standards to improve integration of clinical data
- Enhances patient safety by helping to provide prescribers and consumers with improved access to information needed to make better risk management decisions in a format that will enhance integration with other technical and clinical applications.
- Supports retention of legacy product labeling in databases
- More than 22,000 FDA approved labels (package inserts)
Product manufacturers are required by law to submit product information documents because they are responsible for creating or marketing a product. There are also other persons and organizations who are compelled by other motives to submit information about products, whether or not they are the original creators. SPL is an Health Level Seven (HL7) standard that has been adopted by the U.S. Food and Drug Administration (FDA) as a mechanism for electronically publishing medication information. SPL is also used by the FDA for the submission of other regulatory information supporting product labeling, specifically for establishing registration and labeler information.
|HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 3: FDA Content of Labeling||
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- Regulated Products
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