This page list changes to valdiation rules distributed as validation alerts between published versions of the official validation procedures.
These types of validation procedure alerts will only be communicated when related to the addition of validation procedures which have the potential to affect a large amount of SPL submissions should the information not be relayed prior to the publication of a new release of the SPL R4 Validation Procedures document.

Validation Alerts issued for version 2 Revision 200908241430

The following table of contents is in alphabetical order, but the entries are posted in the order in which they are distributed by the FDA, newest last.

Deprecation Of A Marketing Category Name
Empty State And Zip Code Elements
Images in Principal Display Panel Sections

Image Sizes
Proprietary And Nonproprietary Names In Product Data Elements Section

SPL R4 Errors Which The Pragmatic Validator Will Not Detect
Use Of "NA" As A Marketing Category Value For Non-Application or Monograph Products.
zip Files And SPL IG & VP Note

1. Images in Principal Display Panel Sections

(distributed 21 October 2009)

Due to the receipt of several SPL documents submitted via the eList system with incorrect placement or omission of images of the representative sample of carton/container label(s) in the appropriate SPL content of labeling (major, not subsection) section identified as "Package.Label Principal Display Panel," a new technical validation procedure has been added.
The validation procedure is: "
There must be a section with the code 51945-4 (carton/container label)." The code "51945-4" is the LOINC associated with the (major) section heading "Package.Label Principal Display Panel."

2. Image Sizes

(distributed 23 October 2009)

Due to the receipt of several listing SPL documents submitted via the eList system with image file sizes over 1 MB, a new technical validation procedure has been added.
The validation procedure is: The size of each image file referenced in a listing SPL files should be under 1 MB in size.
In addition, please ensure that the images can be viewed on a computer screen without scrolling. Also, ensure that you are sending actual jpeg files and not another type of image file which has a file name with a file extension inappropriately replaced with "jpg."


3. zip Files And SPL IG & VP Note

(distributed 13 November 2009)

This SPL R4 Validation Procedure Alert is to announce that we are receiving a large amount of zip files containing SPL documents. Each SPL document and any image file(s) associated with that SPL document should be packaged in a single folder. The folder containing the SPL document and any associated image file(s) should be uploaded via the FDA Gateway OC portal.
It appears that the erroneous submission of the SPL documents in zip files is related to:
1. Provision of SPL documents in a zip file by SPL conversion vendors - Companies have stated that they loaded the file as provided by their conversion vendor. You may want to emphasize that SPL documents packaged in a zip file and then transmitted to FDA will not pass validation.
2. Zipping of SPL document and image file to test via the Pragmatic Data Validator Lite tool - After testing the SPL document and image file(s), unzip the file(s) and transmit to FDA in a folder.

Important note for SPL authoring software vendors: Ensure that your SPL authoring tools create SPL documents which conform to both the SPL R4 Implementation Guide AND SPL R4 Validation Procedures. The SPL validation procedures are not a measure of what is acceptable nor is it what is fully required. Just because a file "passes" the validation procedure, it does not mean that the file is correct.

4. Deprecation Of A Marketing Category Name

(distributed 14 November 2009)

This SPL R4 Validation Procedure Alert serves as an announcement of the scheduled date to deprecate the marketing category name "unapproved drug" from the list of acceptable SPL terms.
On September 1, 2009, a notification regarding the replacement of the name of the marketing category "unapproved drug" with "unapproved drug other" was sent to FDA Data Standards Council website listserv members. Therefore, SPL authoring software vendors have had over two and one-half months to make updates to their software to replace this name.
The date scheduled for the deprecation of the marketing category term name "unapproved drug" is
Friday, November 27, 2009.
No further communication regarding the deprecation of this name is planned.


5. SPL R4 Errors Which The Pragmatic Validator Will Not Detect. (distributed 17 November 2009)


The Pragmatic Validator Lite Tool is a great resource to utilize to detect technical errors in your SPL R4 documents. However, the validator is NOT connected to the FDA database and therefore will not detect ALL SPL R4 Errors. Listed below are some of the validation errors that the Pragmatic Data Validator Lite tool will not detect.
Some SPL R4 Errors Undetected by Pragmatic Data Validator Lite Tool

Error
Solution

id must not be associated with any other set id for document type "Establishment registration"


Use the original setId of your initial Establishment Registration SPL document.


First segment matches an NDC Labeler Code associated with the Labeler id.


Ensure that the labeler code and labeler’s DUNS Number is identical to the labeler code and labeler’s DUNS Number in your drug listing SPL document.


If the NDC Product Code was previously submitted, then the product and generic name, active ingredient UNII, dosage form, active ingredient strength, product characteristics of size, shape, color and imprint code must be the same as in the most recent submission for this NDC code.


-The values of the data elements listed in the table cell horizontally adjacent to this cell should match those of the previous SPL for the product(s).
- If aforementioned values differ from those in an SPL R3 document then request a "manual override."
- If request is not granted, you will be contacted via e-mail.
- If request is granted you will NOT be notified.


The id with the root 2.16.840.1.113883.6.69 is not associated with any other document of type "NDC Labeler Code request" with a different setId


Use the original setId of your initial NDC Labeler Code SPL document with this labeler code.


The id with the root 1.3.6.1.4.1.519 along with the establishment postal code (if any) and country match the DUNS number, postal code and country in Dun and Bradstreet database


Ensure that DUNS Number and address is correct.


If the NDC Package Code has been previously submitted, then the package form code and quantity value and unit are the same as in the most recent submission for this NDC code


- The NDC Package Code should match the one in the previous SPL for the product(s).
- If aforementioned values differ from those in an SPL R3 document then request manual override. Request will be reviewed.
- If request is not granted, you will be contacted via e-mail.
- If request is granted you will NOT be notified.

6. Use Of "NA" As A Marketing Category Value For Non-Application or Monograph Products.

(distributed 21 November 2009)

We have noticed that some of the SPL software vendors continue to utilize "NA" in the Application Number or Monograph Citation "field" when no application number or monograph citation is available.
The SPL R4 Implementation Guide specifically states: "If there is no application number or monograph citation, the id element is omitted."
Therefore,
do not include "<id nullFlavor="OTH" root="2.16.840.1.113883.3.150" extension="NA"/>" in the marketing category coding.
Included in the introductory paragraph of the SPL R4 Implementation Guide is this statement:

"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)."
Included in the list of changes in the SPL R4 Implementation Guide is this bullet:
"Remove that element values may be changed by FDA "
This means that SPL document authors have the responsibility to update their SPL documents to remove "NA" from the marketing category coding.

If necessary, we will compile a list of SPL documents with this issue and contact drug companies to request that they resubmit their SPL document(s) without "NA" in the aforementioned ID element.

7. Proprietary & Nonproprietary Names In Product Data Elements Section

(distributed 11 December 2009)

This SPL R4 Validation Procedure Alert is to announce that we are receiving a large amount of SPL documents with dosage forms, routes of administration, etc... in the proprietary and nonproprietary name fields in the product data elements section.
In release three SPL documents, the dosage forms, routes of administration, etc... were removed from the proprietary and nonproprietary names in the product data elements section.
If this information is included in the aforementioned fields in release four SPL documents, you will receive an error message requesting that you remove this type of data.



8. Empty state and zip code elements

(distributed 11 January 2010)

This SPL R4 Validation Procedure Alert is to announce that empty state and zip code elements should not be included in Establishment Registration SPL documents submitted to FDA.