FDA SPL for SPL R4  - Structured Product Labeling - User Manual

(c) sartori-software.com 2011

Introduction to FDA SPL R4
Introduction to the Software
System Requirements

Software Installation
SPL R4 Document Authoring Overview
SPL R4 Document Items
Technical Specifications


Introduction to the Software

FDA SPL is a software that aids pharmaceutical companies and the repackaging/ re-labeling Industry to author SPL files needed to register with US Food and Drug Administration.

The application allows easy document authoring by displaying SPL structured data in a comprehensive tree view.

The product label itself can be authored in Microsoft Word and then be loaded into the SPL document authored with FDA SPL application.

Alternatively SPL document sections as well as coded information such as products, ingredients, product characteristics etc. can be imported from existing SPL files e.g. from those available on the Daily Med website.

All Dictionaries required by the Food and Drug Administration for correct SPL coding and submission are integrated and can be easily accessed.
The Application allows full text search with wildcards in the installed dictionaries such as LOINC, UNII Codes and NCI Thesaurus.

Structured Company Information can be added such as

  • Labeler

  • Registrant

  • Establishments of different types including, but not limited to Manufacturers

  • US Agent

  • Import Company

Following structured Product or Medical Kit Data can be authored:

  • Product Trade- and Generic Name

  • Active and Inactive Ingredients

  • Packaging

  • Marketing Information such as Application Number and Marketing Date

  • Product Characteristics

  • Products delivered as Kits

Excerpt of Structured Product Data can be easily added and saved for later/subsequent submissions

  • Trade Name, Generic Name, Company Information and Legal Authenticators
  • Indications
  • Preconditions such as Co-Administration, Patient Age and Maximum Dose
  • Contraindications
  • Ingredients and Eccipients (Inactive Ingredients)
  • Drug Interactions
  • Adverse Reactions


System Requirements

  • Microsoft Windows Operating System

  • Microsoft Word (optional)

  • Web Browser and Internet Connection for viewing SPL XML files

  • SPLCodeSystems.mdb Access Database containing: NCI Thesaurus, LOINC and UNII Codes - See FDA SPL Website for more information: 

  • MDAC 2.6 or later (Microsoft Data Access Components) for SPL Code System database access


Software Installation

If you have already installed a previous Version of the Application, 
uninstall it first before installing this version! 

  • Double Click the FDA_ SPL_forSPLR4Setup.msi Windows Installer Package

  • Follow the Instructions on your screen
    If a setup Warning/Error occurs, please ignore it

  • Unzip the File SPLCodeSystems.zip and copy the resulting File SPLCodeSystems.mdb to your application installation folder.

  • Updating SPLCodeSystems.mdb Access Database containing: NCI Thesaurus, LOINC and UNII Codes:
    The code systems have data status April 2011 - for updates please contact office@sartori-software.com


SPL R4 Document Authoring Overview

Main User Interface Window

File Menu

  • Save Information to Text File
    Saves the text in the Code Search Result and Processing Information Window to a Rich Text Format File (*.rtf)

  • Review SPL File (XML) 
    Renders the selected SPL file to a comprehensive and searchable Tree View. 

  • Exit
    Exits the Application

Window Menu
Arrange and/or tile multiple windows on the screen for better editing


SPL Data Edit Window - Single Information Item:
Double Click or select and press enter on the item to be edited.

SPL Data Edit Window - Multiple Information Item:
Double Click or select and press enter on the parent item of the items to be edited.

SPL R4 Processing Information Window

SPL Document Menu

Create New
Creates a New and empty template for SPL R4 Document authoring: Establishment Registration, Drug Listing, NDC Labeler Code Request etc. 

Open an existing SPL R4 document. 
Hint: You can create SPL R4 document templates for your different submissions.

Save Settings/ Save Settings As...
Save the authored SPL R4 Settings Document to file.

Create Document Report
Creates a HTML Report containing all data of the SPL R4 File - The Report can be used for company internal documentation purposes.
Note: This functionality creates the folder "SPLReportImages" in the same folder where the report file is saved. If you move the report file to another location, the
"SPLReportImages" folder needs to be copied as well.

Search/ Replace
Search and/or replace text in the SPL R4 Document.
Note: you can search also for empty values

Import Product Label from Word...
With this menu the Product Label in Microsoft Word Document Format can be imported to SPL Document being authored. Please see
Product Label user manual section for details.

Add LOINC Codes to Product Label
With this functionality, required LOINC codes can be added retroactively to the SPL document being authored once the Label has been imported from Word Document.

Build SPL
Creates the SPL file for FDA submission from the SPL R4 Document authored.

SPL Online Validator
Connects to the FDA/Pragmatic Data online Validator under:

The online Validator discovers 95% of the errors in an SPL document.
Its strongly recommended that an SPL Document is checked with the online Validator before being submitted to FDA

Search Code System by Code or Name
With this utility the SPLCodeSystems.mdb database can be searched for available codes by name or the code itself - Code systems provided are: LOINC, NCI Thesaurus and UNII codes.
Enter the text to be searched,  select the desired code system then press enter or click Search.
All codes and names found are displayed in the Log window.
To clear the Info Window content, click the "Clear" button.
If you want to copy Text from the SPL Info Window you can use MS Windows Command CTRL+C, or right click.
Whenever an Item in the document tree has to be coded with a code system, the data entry form will display the search button "[?]" enter, the name or code then click the button. Corresponding codes will be listed.

Editing SPL R4 Document Information and Building SPL file for submission
The SPL R4 Document Information is displayed as a tree view, you can navigate via mouse or keyboard trough the tree items and edit the desired data.

To edit an information item, double click it or press enter on your keyboard.
Depending on the SPL R4 information to be entered, the application renders Code Search Functionalities, Drop Down lists etc.

Information can be dragged and dropped between tree items even on different SPL R4 Document Windows (left mouse button) and from the code system search results (right mouse button)

Once you are done with the SPL R4 document authoring, the SPL file for FDA submission can be generated with the menu function "SPL R4 Document" > "Build SPL"

The right mouse button provides additional editing and import functionalities on tree items - the menu entry displayed depends on the selected tree item.

Shows the Data Edit Window depending on the selected item

Set Color...
Allows to set the back color of the selected item.
This function is useful to mark items for later editing.

Open File/Folder 
Opens the file or folder of the selected item (e.g. Image Files)

Create IDs and GUIDs
Creates the ID/ GUIDs needed in SPL Document Sections of all sub-items of the selected tree item.

Import Data from Existing SPL File...
Imports data to selected tree item from an existing SPL file  - e.g. from SPL files available on Daily Med website.

Clone "Information"
Create a copy of the selected information item

Add Information
Add more Information to the selected Information Item

Copy Selection
Copy Information Item Name and Text to Clipboard

Expand All/ Collapse All
Expand/ collapse SPL R4 Document Tree

Remove "Information"
Remove Selected Information Item

More information about the data requested by FDA for SPL R4 submissions and on authoring SPL R4 Documents can be found under:

FDA SPL R4 Online Resources

An online validation tool for SPL R4 Documents is provided under:


SPLR4 Document Items 
General DataGeneral SPL Document Information such as ID, Title, Version etc.
LabelerLabeler information and all its dependent company data such as registrant, manufacturer, us agent etc.
ProductsProduct listing including Proprietary Name, Ingredients, Packaging, Marketing Information and Product characteristics
Carton LabelCarton Label Information such as image and descriptive text.
Product LabelProduct Label, Word Document Setup and Structured Data such as Indications, Contraindications, Conditions of Use, Drug Interactions etc.
Product Label from Existing SPLLoads the Product Label section from an existing SPL File - Sections to be omitted can also be configured.



Technical Specifications

Product Label SPL XML Template

FDA SPL for SPL R4 uses an SPL XML template that is populated with the data contained in the Word document product label. 
A second template file is used to append Images to the target SPL document.

The template files are located in application installation folder, LabelDefinitions subfolder


HL7 SPL XML file structure.


HL7 SPL XML template for multi media data - images.


HL7 SPL XML template for adverse reactions


HL7 SPL XML template for condition of use - patient age


HL7 SPL XML template for condition of use - co administration


HL7 SPL XML template for condition of use - monitoring


HL7 SPL XML template for contraindications


HL7 SPL XML template for dosage characteristics


HL7 SPL XML template for drug interactions


HL7 SPL XML template for indications


HL7 SPL XML template for ingredients


HL7 SPL XML template for maximum dose


HL7 SPL XML template for product data
WORD_2_SPL_SETUP_TEMPLATE.xml HL7 SPL XML template for settings save/load

Document XML Template and Transformation

2 Template files and one transformation definition file are located in the application installation folder, SPLR4Definitions subfolder

This file contains the information about the SPL R4 Document and is used for user interface rendering - tree view. 

The SPL R4 template document from FDA - the data of the SPL R4 Document is tranformed into this file by using the instructions in  TransformSPLR4.xml

Tranformation definition from DefinitionSPLR4.xml to TemplateSPLR4_FDA.xml

The technical specification of the definition attributes meaning is beyond the scope of this document

SPL R4 File Viewing
The appearance of the final SPL document is controlled by a style sheet (XSLT)  provided online by FDA. Also the XML schema and data type definition DTD is provided by FDA.
To correctly view the SPL file the computer must have an internet connection. Downloading the style sheet, data type definition and XML schema is not possible.

The other files contained in the Definitions folder are provided by HL7 and FDA. They represent style sheets and transformation files for manipulation and display of SPL XML files.

The explanation of the SPL specification is beyond the scope of this document.
The SPL specification and more information are available on the HL7 and FDA websites.

SPL Code Systems Database
The SPLCodeSystems.mdb contains 3 data tables: LOINC, NCI Thesaurus and UNII Codes - Data status is April  2011
The database is located here: Application Installation Folder\SPLCodeSystems.mdb
If updated codes are needed please contact the software vendor: office@sartori-software.com


(c) sartori-software.com 2011