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Other Useful Websites:

Registered Establishments [DECRS] / UNIIs / NDC Directory / FDA Data Council / DailyMed Site / DailyMed Mobile app.

Drugs @ FDA / Pragmatics Validator [if validator is down, send an e-mail to spl@pragmaticdata.com]

News from the SPL Cybersphere

[19-Jun 2017] Link to 2016 Establishment Registration webinar highlighting changes with the 2016 amendments
Katharine Detweiler from Teva provided the link below to a very informative CDER webinar on Establishment Registration, given in September 2016. It is a good refresher for those already familiar with establishment registrations and can help answer many questions. The webinar highlights changes that occurred with the 2016 amendments to the drug listing requirements and is titled CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Establishment Registration and Listing for Human Drugs.

The link is https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm521365.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

[24-Mar 2017] SPL Terminology changes
The FDA is adding terms to SPL terminology for marketing categories, business operation qualifiers, and route of administration. It is also changing the country codes for some countries as it transitions to a new country code list. In the future, the added terms for marketing categories and business operation qualifiers are expected to replace current terms.

Please click here for the list.

[11-Oct 2016] Upcoming Meeting with FDA on Final Rule For Drug Registration and Listing and on Common SPL Mistakes
At the next SPL Process ER/DL Meeting, FDA's Leyla Rahjou-Esfandiary will discuss the Final Rule for drug registration and listing and Paul Loebach, Director of EDRLS Group, will discuss common SPL mistakes. Please send questions to Patricia L Cowall-Hanover in advance of the meeting. We will still have open questions during the meeting.

For the 2016 SPL Jamboree slide presentations on these topics click here for Final Rule and here for Common Mistakes

The Federal Register Notice for the Final Rule is at https://www.gpo.gov/fdsys/pkg/FR-2016-08-31/pdf/2016-20471.pdf.

[23-Mar 2016] Upcoming Changes To SPL Drug Listings and Establishment Registrations
The FDA will soon require
  1. start marketing dates for packaging information for CDER products to improve their accuracy in the Comprehensive NDC SPL Data Elements (NSDE). If the start marketing dates for packaging was not provided by the manufacturer/distributor the FDA was deriving the start marketing date for inclusion in the Comprehensive NDC SPL Data Elements (NSDE).
  2. business operation qualifiers in establishment registrations to improve the inspection effort and cross-checking the FDA does to ensure compliance.

For more information see items 1 and 2 in the minutes of the March 9 ER/DL Team meeting in .

[28-Jan 2015] Proposed Paperless Labeling Rule
The comment period for the FDA's proposed Paperless Labeling Rule ends March 18. The proposed rule is at https://www.federalregister.gov/articles/2014/12/18/2014-29522/electronic-distribution-of-prescribing-information-for-human-prescription-drugs-including-biolological.

You can see the minutes of the discussion of the rule at the January 14 ER/DL Team in . Terry Brunone has provided a slide presentation of notes on the rule, see .

[14-Jan 2015] SPL Stylesheet Update
An updated version of the SPL stylesheet will be posted on FDA’s AccessData web server today (Jan 14, 2015).
One immediately noticeable alteration is the display of the Unique Ingredient Identifiers (UNIIs) adjacent to the substance names in the product data elements section.
Other SPL stylesheet changes are related to the display of data included in recently implemented SPL document types (Human Compounded Drug Product Label, Wholesale Drug Distributor and Third Party Logistics Report, Lot Distribution Data, etc…)

The changes to the stylesheet will be discussed during the January 26, 2015, SPL Document Authoring Commercial Software & Conversion Vendors training session 129

[02-Jan 2015] SPL Training Sessions for January 2015
Many new SPL document types were implemented during the latter half of 2014. To help the SPL creators and submitters and vendors, there will be an SPL Document Authoring Commercial Software & Conversion Vendor follow-up training session EVERY Monday (except January 19, 2015, because it is a US Federal holiday) in January 2015, 3:30-4:30 p.m. ET.
Details regarding these training sessions, how to register, and additional training to be provided later in 2015 are available on the FDA SPL Standard training web page.[http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm155705.htm].

[25-Dec 2014] SPL Submissions to FDA for Dec 25 and Dec 26, 2014
FDA will be officially closed on Thursday, December 25, 2014, for the US Federal Government holiday Christmas Day. Also, FDA will be officially closed on Friday, December 26, 2014, due to a US Presidential “Executive Order -- Closing of Executive Departments and Agencies of the Federal Government on Friday, December 26, 2014”: http://www.whitehouse.gov/the-press-office/2014/12/06/executive-order-closing-executive-departments-and-agencies-federal-gover.

Although FDA will be officially closed on those two days, all SPL submissions transmitted to FDA on those two days should be automatically processed. US Federal Government websites which publicly display SPL data may not be updated on those days but should be updated the next business day, Monday, December 29, 2014.

[17-Sept 2014] Updated layout for DailyMed
See it now at DailyMed website (http://dailymed.nlm.nih.gov/dailymed/index.cfm).

[16-Sept 2014] Combination Product Category Validation Procedure
Here is the combination procedure validation procedure which is currently being sent to companies which do not include the combination product category in the appropriate SPL files:
  1. Combination product type characteristic is on the inner-most packaging except if the document type is for bulk ingredient (53409-9), OTC animal drug (50577-6), OTC type A (50576-8), OTC type B (50574-3), OTC type C (50573-5), prescription animal drug (50578-4), VFD type A (50575-0), VFD type B (50572-7), VFD type C (50571-9), Cosmetic (58474-8), Dietary Supplement (58476-3), Medical food (58475-5).

[10-Sept 2014] SPL Training Sessions for Vendors
Follow-up SPL Document Authoring Commercial Software Vendor Training Sessions have been scheduled on Mondays on these dates and at these times:

Date: September 8, 2014
Time: 3:30 – 4:30 p.m., EDT

Date: October 27, 2014
Time: 3:00 – 4:00 p.m., EDT

Date: November 10, 2014
Time: 3:00 – 4:00 p.m., EDT

Date: December 8, 2014
Time: 3:00 – 4:00 p.m., EDT

If you are interested in attending the aforementioned sessions via web conference, please send a registration request to spl@fda.hhs.gov.

[31-Aug 2014] Starting September 1, 2014 - Validation of Combination Product Category Data Element
As of September 1, 2014, human OTC and Rx drug labels will be validated for the inclusion of the combination product category date element. FDA is currently working to address some questions that have arisen with some of the SPL-related combination product category questions. This includes questions related to OTC combination product types. x

[29-Aug 2014] Updated version of SPL Implementation Guide/Validation Procedures now available
To accompany the August 29, 2014 publication of the FDA’s draft “Guidance for Industry – Electronic Submission of Lot Distribution Reports,” an updated version of the SPL Implementation Guide/Validation Procedures document which includes a specific reference to the aforementioned guidance document has been posted: http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM321876.pdf.

[27-Aug 2014] Open FDA and additional resources for using SPL

Link to article talking about the Open FDA resources: https://open.fda.gov/update/drug-product-labeling/

There is an OpenFDA e-mail address which was set up specifically to answer questions regarding OpenFDA.

Note that at the very top of the web page are the following statements: “We're in beta! openFDA is a beta research project and not for clinical use.”
At this time, this is a research project. Many questions are answered on the web page (https://open.fda.gov/) already.

Here is a just one snippet from the web page which seems to some of the answers:
“Although it has been publicly available for many years on FDA’s website, now this labeling is available on openFDA through an Application Programming Interface (API), which provides a way for software to interact directly with the data.

“For several years, the labeling have been posted publicly in Structured Product Labeling (SPL) format at http://labels.fda.gov/. The SPL format enhances the ability to electronically access, search, and sort information in the labeling. The SPL files are also available at the National Library of Medicine’s DailyMed site and can be downloaded. We’ve created an API for the data to supplement (not replace) these resources, and to provide easy and timely access to changes or updates to the labeling.”

NLM also has developer resources for working with SPL data: DailyMed APIs: http://dailymed.nlm.nih.gov/dailymed/help.cfm#webservices.
Note: Recently, DailyMed staff added a few new APIs that they would like for software developers to review.

[01-Aug 2014] Now available: Substance Indexing SPL data is now accessible through PubChem
that National Library of Medicine has automatically imported the substance indexing SPL documents (SPL data made available by FDA) into its’ PubChem database.

The substance indexing SPL documents have additional data (such as, if applicable, the chemical structure) about the substances and UNIIs which are included in product SPL files generated by companies. As you are aware, the product SPL files sent to FDA which are eligible to be made publicly available are subsequently published in public repositories such as NLM’s DailyMed and FDA’s Labels.fda.gov.

Here is the hyperlink to the PubChem web database: http://pubchem.ncbi.nlm.nih.gov/.

If one queries PubChem using a UNII and selects the “Substance” query option, he or she will receive a results page similar to the one displayed in the document attached to this e-mail. If an indexing SPL file exists for the UNII, there will be two links related to the appropriate substance indexing SPL file in the results. The link named FDA/SPL Indexing Data will direct users to the downloadable versions of the substance indexing SPL files. The link with the UNII as the name will display the substance indexing SPL file associated with that UNII.

In addition, software vendors may programmatically connect to the PubChem repository to access the substance indexing SPL data and, for example, make the chemical structure available to their clients to assist the SPL document author to determine the correct substance name/UNII to select for their product SPL document. There are a number of programmatic methods to work with PubChem. PUG REST is one of these:

More information about the substance indexing SPL documents is included in the Indexing SPL Fact Sheet http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM345939.pdf.

[20-Jun 2014] SPL Dailymed Jamboree - Registration now open!
National Library of Medicine has announced the 2014 SPL/DailyMed Jamboree Workshop which is scheduled for September 18, 2014, at NLM in Bethesda, MD. More information (including the agenda) regarding this free public SPL workshop is posted on this NLM web page: http://www.nlm.nih.gov/mesh/spl_workshop_2014.html.

[09-Feb 2014] Requirement for inclusion of Combination Product Category Data Element
Beginning May 1, 2014, SPL files with the document types listed directly below will be validated for inclusion of the combination product category data element:
  1. Cellular Therapy
  2. Licensed Minimally Manipulated Cells
  3. Non-standardized Allergenic
  4. Plasma Derivative
  5. Standardized Allergenic
  6. Vaccine Label

In addition, SPL files which include an application number preceded by “BA” or “BN” are included this first phase (described above.)

Beginning September 1, 2014, SPL files with the document types listed directly below will be validated for inclusion of the combination product category data element:

  1. Human OTC Drug Label
  2. Human Prescription Drug Label

[13-Jan 2014] New Substance Indexing Files now available
The substance indexing SPL documents are posted on this FDA SPL webpage: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm377913.htm.

To assist users of the substance indexing SPL files, also accessible via that web page is a text file with a list of the set IDs, document IDs, etc.., included in each of the substance indexing SPL files. This file will be updated each time new substance indexing SPL documents are posted.

For more information about substance indexing SPL files, please review the Indexing SPL Fact Sheet: http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM345939.pdf.

If you would like to be notified of updates of these files, please request to be added to the distribution list by sending your e-mail address to spl@fda.hhs.gov.