HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 1

DESCRIPTION

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.

ALTERNATIVE NAMES

HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 1 may also go by the following names or acronyms:

TARGETS

• Pharmaceutical Companies
• Veterinary Drug Product Companies
• Biologic Drug Companies
• Producers of Bulk Drug Products

BENEFITS

See HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 5

IMPLEMENTATIONS/CASE STUDIES

• More than 5000 FDA approved labels (package inserts)

DEVELOPMENT BACKGROUND

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.

RELATED DOCUMENTS

HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 1

(Download) (895 KB)

TOPIC

• SPL

BALLOT TYPE

• Informative

STATUS DATE

2005-01-15

RESPONSIBLE WORK GROUP

FAMILY

• V3

CURRENT STATE

• Retired

REALM

• Universal