Archive of News Items from 2011 and earlier


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[23-Dec-2011] A proposal for archiving SPL files on DailyMed - input requested

The FDA has been asked to make the process of archiving SPL R3 or duplicate SPL R4 documents on DailyMed easier while still transmitting files from industry to DailyMed without alteration.

FDA proposes the use of a not-yet-utilized SPL data element (the "relatedDocument" data element) to reference the replacement SPL R3 or R4 file. If there is agreement by the SPL community, this data element can then be included in an SPL file transmitted for the purpose of notifying FDA's and NLM's system that an instance of an SPL R3 or duplicate SPL R4 document should be transferred to the DailyMed archives.

Here is an example of the coding:

<relatedDocument typeCode="RPLC">
<relatedDocument>
<id root="464239de-45c7-4d2f-a89a-45d303f428bd"/>
<setId root="9ea75e1e-84ef-4605-89ff-dd08a4c94f40"/>
<versionNumber value="3"/>
</relatedDocument>
</relatedDocument>

Note: The setID for the SPL R3 or R4 file which needs to be archived (replaced) will be the reference ID.

If you have a reason that this optional functionality should not be implemented, e-mail the FDA at spl@fda.hhs.gov with a complete description of the opposition to the use of the relatedDocument element by Friday January 20, 2012

If any opposing views are received, they will be discussed in open forum at the January 30, 2012, HL7 SPL Tech Team meeting.

Should there be successful resolution of any opposing views at this meeting, SPL files with the relatedDocument element could then be transmitted to FDA beginning in February 2012 by SPL document authors which need to archive an SPL R3 or duplicate (ONLY) SPL R4 file.

[19-Dec-2011] Implementation of Validation Rule Linking Product Codes to Establishments & Business Operations - Feb 1, 2012
This validation will require NDC product codes to be related within the SPL file to each manufacturing establishment and the business operation performed. Currently, establishments are electronically associated to the entire SPL file (all products) -- and are not associated with any specific products. This does not allow a downstream user to determine the which establishment(s) are involved with a business operation for a given NDC product. This new validation procedure will address this downstream need.

This process/validation rule has been part of the SPL validation procedures since Aug, 2010. This process/validation change was communicated to vendors in February, 2011, so that they could start preparing to implement this in their software. You can find details in the new "SPL Implementation Guide with Validation Procedures" in section 4.1.5: http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM282146.pdf

Note: the link in the message below to an SPL example containing the product-to-establishment relationship does not properly display the data in IE. The link below is to Daily Med - which has not yet updated its stylesheet. Here is a link to the FDA access database which displays the example in FDA's updated stylesheet (scroll down to the establishment data at the end of the file):
http://www.accessdata.fda.gov/spl/data/8ee1cd0e-bad7-48ff-9e25-8710edb812ec/8ee1cd0e-bad7-48ff-9e25-8710edb812ec.xml

This change will be discussed at the SPL ER/DL subteam meeting on Wednesday January 4th 1:00-2:00 ET and at the SPL Process Communication Forum on Wednesday January 11th 1:00-2:30 ET (call-in information will be provided under separate cover). You can submit additional questions -- so that we can get answers from Lonnie and the DRLS staff. This information will also be published on the WIKI.

We also encourage you to contact your SPL vendors to verify that this change has been (or will be) included in the software that you are using.

*

The product-to-establishment data relationship validation procedure for content of labeling/listing SPL documents with information about drug products regulated by CDER will be implemented on: February 1, 2012.

  • The previous date for the aforementioned implementation was January 2, 2012.
  • Please ensure that your client's SPL document authoring software is capable of linking the product to the establishment PRIOR to February 1, 2012.
  • Note: A copy of this e-mail is also being sent to the HL7 SPL WG subteam leaders for dissemination to the HL7 SPL WG subteam members.
  • Here is an example of an SPL file posted on DailyMed which has the product-to-establishment relationship:http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?ndc=63459-548&start=1&labeltype=all

If you have questions or comments regarding the contents of this message, please do not hesitate to contact us at spl@fda.hhs.gov.

[19-Dec-2011] Change in Name of SPL Listing Data Elements Section (LOINC 48780-1

Currently, a drug product's data elements are described in a section of an SPL document with the LOINC name "SPL Listing Data Elements Section" and LOINC 48780-1.
The FDA is expanding its use of SPL, and this section may be used for purposes other than the listing of a drug. The FDA has decided to change the name of the section.

The LOINC section header name will be changed from "SPL Listing Data Elements Section" to "SPL Product Data Elements Section" for the LOINC 48780-1. Vendors and sponsors must change their software or coding practices to use the new term "SPL Product Data Elements Section"


The implementation schedule for the change to the new term and the deprecation (removal) of the old LOINC name "SPL Listing Data Elements Section" is:

January 1, 2012 - May 31, 2012 -
Both section header LOINC names ("SPL Listing Data Elements Section" and "SPL Product Data Elements Section") will validate when associated with the LOINC 48780-1.

June 1, 2012
"SPL Listing Data Elements Section" will no longer be a name associated with the LOINC 48780-1. [the removal of the term is called 'deprecation']
"SPL Product Data Elements Section" will be the only section header name that can be associated with the LOINC 48780-1.


To ensure that industry has time to update their systems to associate the new name with the LOINC 48780-1, please update your software to generate SPL files with the updated LOINC name "SPL Product Data Elements Section" PRIOR to the June 1, 2012, deadline.

[18-Dec-2011] Updated SPL Stylesheet now available at FDA Data Standards Council website
The FDA Data Standards Council’s website's SPL web page was updated Sunday, December 18, 2011, to include an updated SPL stylesheet:

http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
Also, the links to the archived versions of the SPL Implementation Guides and SPL stylesheets were removed. If you would like receive a copy of a previously utilized SPL Implementation Guide or SPL stylesheet, please send an e-mail request to spl@fda.hhs.gov.

[15-Dec-2011] News from FDA SPL Group - Archiving Retired SPL on DailyMed

FDA is finalizing the solution which will afford an opportunity for SPL document authors to archive on DailyMed SPL R3 documents which need to be "retired" and instances of SPL R4 documents, which due to the combination of package inserts, need to be archived on DailyMed.

The solution will not require the marketing status to be added (SPL R3) or updated to "completed" (SPL R4) or the addition of marketing start and end dates (SPL R3) or entry of a marketing end date (duplicate SPL R4.)

Once the solution is finalized, we will disseminate the instructions which will allow drug companies to archive SPL R3 and duplicate SPL R4 documents. We expect to publish the solution in the near future.

Until those instructions are made available, unless there is a potential safety issue if a R3 file is not removed from DailyMed, FDA requests that you hold all requests for the manual archival of SPL files on DailyMed.




[05-Dec-2011] Updated SPL stylesheet now available
The FDA Data Standards Council’s website's SPL web page was updated Sunday, December 4, 2011, to include an updated SPL stylesheet:
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm

[03-Dec-2011] Updated SPL Implementation Guide/Validation Procedure document now available
The FDA Data Standards Council’s website's SPL web page was updated Friday, December 2, 2011, to include an updated SPL Implementation Guide/Validation Procedures document: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm


[29-Nov-2011] Discontinuation of Paper-only listings via SPL
CDER's eDRLS Team would like to remind the industry about the following change in accepting email requests to discontinue paper listed products.

Please be advised email requests for discontinuing paper listed drugs will be accepted through December 31, 2011. Starting January 2012 firms are required to submit an SPL to discontinue the product.
Please send your questions to eDRLS@FDA.HHS.GOV



[22-Nov-2011] NLM cannot remove outdated R3 files from DailyMed
Despite the past notifications regarding the procedure for converting SPL R3 documents to SPL R4 format to archive an SPL R3 file on DailyMed, we are still being informed by National of Library Medicine (NLM) that companies are contacting NLM staff to manually remove an SPL R3 file from DailyMed.

NLM will continue to inform FDA of an attempt by a drug company representative to circumvent the process of converting an SPL R3 file to SPL R4 to transfer the SPL R3 version to the DailyMed archives. Upon receipt of the notification by NLM, FDA will contact the drug company representative who sent the request to NLM to inform him/her of the proper procedure for transferring an SPL R3 from the DailyMed main search page to the DailyMed archives.




[22-Nov-2011] New version of SPL Implementation Guide / Validation Procedures
Look for new version of combined SPL Implementation Guide/Validation Procedures to be available soon!

[31-Aug-2011] Use 2-letter state abbreviations for Establishment Registrations
Effective immediately, please utilize the two-letter state abbreviation for states located in the United States of America when generating new or updating previously submitted establishment registration SPL documents.

[31-Aug-2011] New search features on Daily Med

NLM recently added a new feature which permits DailyMed users to utilize radio buttons search for either animal or human drugs.

[08-Aug-2011] UNII code requests should now be sent to FDA Substance Registration System (SRS) team

Effective Monday, August 8, 2011, unique ingredient identifier (UNII) assignment requests submitted to the SPL (spl@fda.hhs.gov) e-mail account will be forwarded to the FDA Substance Registration System (SRS) team's e-mail account (fda-srs@fda.hhs.gov.)

A member of the FDA SRS team will receive and process UNII assignment requests. This team will respond directly to you from the FDA SRS e-mail account regarding UNII assignment requests or UNII-related questions.

UNII assignment requests submitted prior to 11:59 p.m., ET on Sunday, August 7, 2011, will be processed for assignment by the SPL team. All UNII assignment requests received after 11:59:01 p.m., ET on Sunday, August 7, 2011, will be processed by the FDA SRS team. UNII requests submitted directly to the FDA SRS e-mail account will be processed by the FDA SRS team.

The downloadable Excel file with UNIIs will no longer be published after Sunday, August 7, 2011. On or before Sunday, August 7, 2011, the SPL UNII web page will be updated to remove the hyperlink to the downloadable Excel file with UNIIs. The link to the FDA Substance Registration System - Unique Ingredient Identifier searchable web database will remain on the web page.

The XML version of the UNII list will be remain as a downloadable UNII file along with the other SPL terminology downloadable XML files in the Additional Validation Files zip file accessible via the SPL web page. When this file is updated, an announcement of its publication will be sent to the over 40,000 subscribers to the FDA Data Standards Council's website listserv.

In the near future, a text version of the downloadable UNII list should be accessible via the FDA SRS web database. Any questions regarding the downloadable text file for UNIIs should be sent to the FDA SRS e-mail account beginning Monday, August 8, 2011.

[12-Jul-2011] SPL Technical Training Session for Home Use Medical Devices and Lot Distribution Data to be scheduled in August 2011
We are planning an SPL technical training session for new data elements related to home use medical device and lot distribution data. This SPL technical training session is related only to the utilization of the SPL standard for collection of this type of data. As most of you are aware, the SPL standard already has data elements for home use medical device and lot data.

The session will be scheduled to occur in August 2011.

In the near future, an announcement with more details will be posted on the FDA SPL training web page and a message regarding the aforementioned SPL technical training session will be transmitted via the FDA Data Standards Council's website listserv.


[11-Jul-2011] New start time for FDA SPL Tech Q&A Sessions: 11 AM

The start time of the Monday AM SPL Tech Q&A sessions has been changed to 11:00 AM, effective, Monday, July 18, 2011.

Day of the Week: Mondays (except federal holidays or when the federal government in the Washington DC metropolitan area is closed due to inclement weather or other reasons)
Time: 11:00 a.m. - 11:30 a.m., ET.
Location: Audio conference
Audio Conference Details: Telephone number: 1-866-775-9435/Participant pass code: 5753366

The time was altered from 10:00 a.m., ET (7:00 a.m. PT) to permit drug companies located in the Pacific time zone to attend the call beginning at 8:00 a.m., PT.

The SPL web page will be updated in the near future to include this new time as well as the audio conference details.

NOTE: Today's (Monday, July 11, 2011,) session is cancelled.


[08-Jul-2011] DailyMed website up to 26,000 entries

As of July 08, 2011, there are over 26,000 unique SPL documents posted on DailyMed.


[07-June-2011] NDC Directory relaunched. Now contains only e-listed NDCs

On June 1, 2011, the NDC Directory switched its data source from the older DRLS system to eLIST. As of June 1, 2011, only drugs for which electronic listings (SPL) have been submitted to FDA will be included in the NDC Directory. Drugs for which listing information was last submitted to FDA on paper forms, prior to June 2009, will be included on a separate file and will not be updated after June 2011.

The FDA has taken this opportunity to overhaul the NDC Directory as well, simplifying its structure, while adding new records (such as OTC products) and new data elements. The new features of the NDC Directory, along with some very important usage notes, are detailed at this page:
http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm

[23-May-2011] FDA-NLM Initiative for PILL Images to be included with SPL
The PILLBOX initiative is a pilot program for the production of standardized high-resolution images of solid oral dose medicines (OTC and Rx). Today’s Federal Register notice posts for a call for participation in the initiative if you are interested in submitting samples to NLM. Note this is currently a voluntary program and does not impact any current regulatory requirements for your SPL submissions.
http://www.gpo.gov/fdsys/pkg/FR-2011-05-23/pdf/2011-12629.pdf NIH Call for Participation in Pillbox Patient-Safety Initiative
Link to PILLBOX Questions and Answers
Training Session slides for
Repacked/Relabled Drugs SPL session and for Prescription Drug SPL sessions are now available here:
Training


[12-May-2011] FDA Contacts Page - Who to ask for SPL and ESG questions

This new page provides the e-mail and contact information for the groups supporting the eListing process - those working in DRLS, with the ESG, and in the SPL technical support area:
Points of contact web page: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/ucm254946.htm.


[29-Apr-2011] DailyMed website up to 23,000 entries

As of April 28, 2011, there are over 23,000 unique SPL documents posted on DailyMed.


[14-Apr-2011] DailyMed website now includes Pharmacologic class search capabilities:

NLM has updated their DailyMed website to include a pharmacologic class search which will enable their users to query for drug product SPL data associated with a particular pharm class. NLM is using the data provided in the pharm class indexing SPL files as a source for their pharm class query. They will also continue to make the individual pharm class indexing SPL files available for download by healthcare information suppliers for importation into clinical decision support systems.

Note: Only the drug product data which has been submitted in SPL format and transmitted to DailyMed will be included in the pharm class query results.

DailyMed users may now search for product information utilizing:

1. Drug product name
2. NDC code
3. Drug class (pharm class)



[17-Mar-2011] SPL Stylesheet: New Version Now Available for Testing
If you would like to preview the next version of the SPL stylesheet, you may utilize the link in the third sentence below.
The preview period terminates at close of business, Thursday, March 17, 2011.
To preview the SPL stylesheet, replace the stylesheet reference in test files with this hyperlink: http://pragmaticdata.com/spl/stylesheet/spl.xsl.

DO NOT transmit official SPL submissions with the hyperlink referenced in the previous sentence.
If you have any technical comments regarding this SPL stylesheet, please do not hesitate to submit those technical comments to spl@fda.hhs.gov by close of business, Thursday, March 17, 2011.
Release notes will be available with the official posting of the SPL stylesheet files. They will not be provided during this preview period.

Note: SPL-to-PDF stylesheet files will no longer be provided with future updates of the SPL stylesheets.


[18-Feb-2011] SPL for Positronic Emission Tomography (PET) Drugs

Links to SPL templates for the three drugs (fludeoxyglucose F18, Ammonia N13, Sodium fluoride F18):
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm241316.htm

If you are likely to be submitting an NDA or ANDA for these drugs, you may want to attend a training session on the creation of SPL for these. A session has been set up on March 8, from 1 to 2:30. To register, contact spl@fda.hhs.gov and provide first & last name of attendee, and organization. Webinar connections are limited.

Draft Guidance:
PET Drug Applications — Content and Format for NDAs and ANDAs [Fludeoxyglucose F 18 Injection; Ammonia N 13 Injection; Sodium Fluoride F 18 Injection]
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078738.pdf

Links to sample 356h forms, CMC sections:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm

[15-Feb-2011] INPUT Requested from SPL User Community!!!
To ensure consistency of information in the SPL R4 Implementation Guide and SPL R4 Validation Procedures files and to eliminate the time and energy necessitated to maintain two documents with very similar data, we are considering combining the SPL R4 Implementation Guide and SPL R4 Validation Procedures documents into one file.

The combined document would still be utilized as a vehicle to discuss the SPL standard with the system developers and other entities with an interest in SPL XML, etc... I have been informed that we would not have to acquire permission from Health Level Seven prior to making this type of decision.

If you have any comments or recommendations regarding this proposal, please do not hesitate to relay your message to us via the SPL e-mail account spl@fda.hhs.gov.

Also, there is an SPL Tech Team meeting scheduled for February 28, 2011, so, if the SPL Tech Team chair and co-chairs opt to add this subject to the agenda for that meeting, you may also voice your comments and recommendations regarding this combined document proposal during that teleconference.

Comments and recommendations regarding this proposal should be sent to the aforementioned e-mail account by Friday, March 4, 2011.

[15-Feb-2011] National Library of Medicine now has DailyMed mobile app
National Library of Medicine just announced their DailyMed Mobile app. When someone accesses DailyMed via a mobile device (phone, etc…), the DailyMed Mobile app automatically launches.


[14-Feb-2011] FDA Online Label Repository now listed on data.gov site
The FDA Online Label Repository has been added to the Data.gov website: http://www.data.gov/tools/4423.
For information regarding the Data.gov initiative, see this web page: http://www.data.gov/.


[08-Feb-2011] Pharmacologic Class Indexing now being sent to NLM
This week, FDA will commence transmitting pharmacologic class indexing SPL documents to the National Library of Medicine (NLM).

Initially, the indexing SPL files will made available via the downloadable zip file which includes the content of labeling/listing SPL files. In the future, in addition to the downloadable version of the files, other DailyMed features may permit the search of pharmacologic class data.

NLM should begin including the pharmacologic class indexing SPL files in the aforementioned downloadable file later this week or early next week.





[04-Feb-2011] FDA Online Label Repository Now Available!!


The FDA Data Standards Council’s website was updated to replace the hyperlink located in the Download Labels subsection on the SPL web page:

http://labels.fda.gov

The FDA Data Standards Council’s Structured Product Labeling Resources page is still available at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.



[31-Jan-2011] SPL Stylesheet updated to render disclaimers for OTC and homeopathic products

The morning of Monday, January 31, 2011, the SPL stylesheet was updated to render disclaimers in the SPL documents with descriptions of drug products identified via the following marketing categories:

1. OTC monograph - not final
2. OTC monograph - final
3. Unapproved drug other
4. Unapproved homeopathic.

The downloadable version of the updated SPL stylesheet will be made available via the FDA Data Standards Council website's SPL web page today, Monday, January 31, 2011.




[31-Jan-2011] Reminder: If a section's content changes, then the section id GUID & Section Effective Time must change as well

For subsequent versions of a content of labeling/listing SPL document, the following is applicable:
  • If the content of a SPL document's section has been altered, the section ID and section effective time should be updated to reflect the change.
  • If the content of a SPL document's section has NOT been altered, the section ID and section effective time should NOT be changed.

SPL documents with a change to the section's effective time value but no change to the section ID will receive the following error:
"id does not match any other id across all sections, documents, or any id other than the id of the same section previously submitted."



[18-Jan-2011]
The FDA Data Standards Council’s website was updated Tuesday, January 18, 2011, to announce the 2011 SPL training session schedule:
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm155705.htm
Please note that the sessions are scheduled from January - June 2011 and from September - December 2011. Currently, there are no SPL training sessions scheduled for July and August 2011.

Also, two of the sessions will be dedicated to specific topics the SPL authoring vendors may discover to be helpful. However, attendance for these two sessions are not restricted to the software vendors.



[14-Jan-2011]
The FDA Data Standards Council’s website was updated Wednesday, January 12, 2011, to include updated terminology:
A. UNII update - http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162523.htm
B. Updated terminology XML File - http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm169455.htm




[13-Jan-2011]
There are over 20,000 unique SPL documents posted on DailyMed.

[12-Jan-2011]
Effective immediately, homeopathic medicines [unapproved homeopathic medicines] will be posted to DailyMed.


[03-Dec-2010]

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/ucm078801.htm
New Marketing Category added


New to eDRLS! A new marketing category has been added for drugs that are not in finished form or packaged for human or animal use. C94795 - Drug for Further Processing, has been created for use with the Bulk Ingredient document type and does not require content of labeling.


[02-Dec-2010]
SPL XForms Alert: The new marketing category "drug for further processing" should be visible in the drop-down menu of the SPL Xforms (version 1.8 of the SPL Starter Package). If you do not see the term, please send a note to SPL@fda.hhs.gov alerting them of this issue.



[18-Nov-2010] NCPDP Working Group 2 link
http://www.ncpdp.org/news_feds.aspx#SPL


[15-Nov-2010] News from SPL - Hypermelloses, Line Breaks in Product Data Elements section, UNIIs, and OTC Validation Resources
  1. More explanation for the change to the preferred term 'HYPERMELLOSES' available here.WARNING!! It is expected that a similar change will be made for POLYETHYLENE GLYCOL and all other polymers for which the FDA SRS team has created a generic term and code in the very near future. Up until now, the FDA SRS team has avoided the POLYETHYLENE GLYCOL change because it affects so many products but low molecular weight polyethylene glycols pose significant safety issues so identifying the specific polyethylene glycol is important.
  2. When entering data in the product data elements section of SPL, do not include line breaks - while they aren't readily apparent, they still register as a character in the XML. If the line break is removed in a subsequent submission, your file will fail validation. And require a manual override. So leave line breaks out of the product data elements section.
  3. OTC Not Final Validation Files (XML & Excel) in Additional Validation Files - http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm169455.htmUpdated terminology XML File - http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm169455.htm
  4. There are now over 19,500 UNIIs - http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162523.htm

[01-Nov-2010]
Here is the contact information provided by Dun & Bradstreet for "self-requested" DUNS Number applications for drug establishments located in China:
"Huaxia D&B China Customer Service when applying for a free self-requested DUNS Number for compliance with the U.S. Government.”

"Huaxia D&B China D-U-N-S Registered service center
**DUNSAPPLICATION@HUAXIAdnb.com**
+86 21 2321-3836 or 400-820-2669"


[29-Oct-2010]
The FDA Data Standards Council’s website was updated Thursday, October 28, 2010, to update the SPL Xforms to include new terminology.
The SPL Starter Package with the SPL Xforms is accessible via this hyperlink: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm189651.htm


[26-Oct-2010]
The FDA Data Standards Council’s website was updated Monday, October 25, 2010, to include updated terminology:
A. Document types - http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162063.htm
1. Cellular Therapy;2. Indexing - Pharmacologic Class; 3. Plasma Derivative; 4. Standardized Allergenic

B. Updated terminology XML File - http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm169455.htm



HL7 SPL news
The "Structured Product Labeling Release 5 Implementation Guide for FDA Establishment Registration, Listing, and UDI Submission" document was successfully balloted on the HL7 October ballot cycle. Below is a link to the new SPL R5 IG:
SPLr5 IGv1.0 - new.pdf

Below is a comparison document to the previous release:
Compare - SPLr5 IGv1.0 - new.pdf



[06-Oct-2010] SPL for OTC monograph products now being posted on Daily Med

Effective immediately, FDA will commence the transmission of OTC monograph SPL documents to NLM for posting on DailyMed. These will include all those SPL received by the DRLS office via eList for OTC monograph products since drug listing has been required


[01-Sept-2010] SPL with missing or miscoded Medication Guide sections - Reports being sent to companies

Reports of SPL documents with missing or miscoded SPL medication guide sections will be disseminated to drug companies identified as the authors of the SPL files. The first reports will be sent Wednesday, September 1, 2010.



[24-Aug-2010] New Revision [201008021527] of Validation Procedures v2.0
[201008021527 on front page is the latest release of] Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing v2.0 PDF


[23-Aug-2010] New validation rules for OTC products, including new validation files
The new validation rule for Drug Listing files for OTC products checks that the active ingredient listed is covered by the monograph part number in the CFR. Excel files for reference are now available at
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm169455.htm.



[19-Aug-2010] Session with Members of FDA's Drug Registration and Listing (DRLS) Group - Minutes now available.

The ER/DL subteam had a Q&A session with Paul Loebach and Leyla Rahjou-Esfandiary from the Drug Registration and Listing group at the FDA. The questions and answers are now available here.

[13-Aug-2010] Change in Training Session Schedule at FDA Effective Aug 16, 2010

Effective Monday, August 16, 2010, SPL Xforms installation demos will no longer be held during the 10:00 a.m. Monday SPL Document Preparation training session.
Instead, the SPL Xforms installation demos will occur from 9:30 a.m. - 10:00 a.m., ET. This change is to afford more time to provide web based demos to address specific and advanced SPL technical document preparation questions asked by attendees of the 10:00 a.m. SPL session.

Here is the new schedule for Mondays SPL training sessions:

9:30 - 10:00 a.m., ET - SPL Xforms installation demos (web conference)
10:00 - 11:00 a.m. ET - SPL Document preparation (web conference)


[30-Jul-2010] Tips on Improving JPGs for Principal Display Panel
Document with tips available on the Packaging Images page of this WIKI




[19-Jul-2010] FDA now posting additional categories of SPL
Effective, Monday, July 19, 2010, SPL documents with the document type "Human Prescription Drug Label" and the marketing category "Unapproved Drug Other" or Unapproved Medical Gas" will be transmitted to DailyMed.

Future Watch: the FDA plans update of validation procedures for the labeling section for OTC SPL drug listing submissions. Please be sure you are including the proper Drug Facts sections for OTC labeling with your e-submissions to minimize the chance of your file being rejected in the future. No time frame for the updated procedure has been announced


[06-Jul-2010] FDA activates validation rule: Business operation listed must match business operation registered
The SPL validation procedure which ensures that the drug establishments named in the establishment data elements section of a content of labeling/listing SPL file are electronically registered and that the business operations match has been activated.

From Validation Rules: 1.6.3.11: Act definition code matches code for an establishment with same id previously submitted in documents of type "establishment registration"

[28-June-2010] FDA adds validation file for Medication Guides
Medguide validation file is contained in the additional validation files zip at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm169455.htm

[26-June-2010] FDA Requests Comments on "Indexing SPL ..."
The FDA Data Standards Council’s website was updated Friday, June 25, 2010, to include a hyperlink to the Federal Register notice for "Indexing SPL for Human Prescription Drug and Biological Products; Request for Comments" on the SPL Resources webpage:

http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.


[21-June-2010] Searchable Database for UNIIs
A new website which will enable SPL authors to search a web-based database for unique ingredient identifiers (UNIIs) has been recently launched.
Here is the hyperlink to the web page:
http://fdasis.nlm.nih.gov.
The FDA Data Standards Council website will be updated to include the hyperlink to this website in the near future.


[3-June-2010] E-mail documenting Import Issues

Communication for Import Issues after filing SPL in accordance with Guidance: Sample letter text and contacts here:


FEI Numbers - Getting Them, Using Them
FEI numbers are issued by the FDA and are used by FDA Inspectors to identify establishments. More information on requesting and using them available.



[04-May-2010] Just the New Rules from the Validation Procedures v2.0
Delta version - list of new validation rules broken out from main document here [thanks pddesai!]

[03-May-2010] New Revision of Validation Procedures v2.0
The latest release of] Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing v2.0 is now available [201005011423 on front page] PDF


[21-Apr-2010] DFARS Updates now available earlier in day
The time for posting updated establishment registration data on the Drug Firm Annual Registration Status (DFARS) website has changed from 4:00 a.m., ET to between 11:15 a.m. - 12:00 p.m. (noon) ET each business day.



[01-April-2010] New DailyMed search feature: Search by NDC
National Library of Medicine (NLM) has added a new feature to their DailyMed website: the ability to search for an SPL via the NDC. If you type in the NDC Product Code (first two segments of the NDC) or complete NDC (three-segment NDC) the label containing the NDC will instantly render.

The former "Search by Drug Name" field is now labeled "Search by Drug Name or NDC Code."



[26-Mar-2010]
!!When the Pragmatic Data Validator Lite tool is down, send an e-mail to spl@pragmaticdata.com instead of spl@fda.hhs.gov. !!
[21-Jan-2010]
The frequency for updates of the Drug Firms Annual Registration Status website is now daily on business days.
Note: occasionally, the update may not occur on a certain date if there is no updated information available for posting or an unforeseen issue arises.


[18-Nov]
Road Map for SPL:

Dun and Bradstreet has just announced a new service to be used for getting a DUNS® number quickly.DUNS Number Request Brochure


The SPL Working Group is conducting a survey of industry plans to implement business processes to support electronic submission of Drug Establishment Registration and Drug Product Listing in SPL format. Your participation in this survey would be greatly appreciated.

Take Survey

The aggregation of information collected through 3/2/09 posted.
See Survey Results