SPL+News+Items+2011+-+2013

=Past News Items from 'SPL in Cyberspace'= link to home page:

A new SPL dosage form and NCI concept code has been added: SPL dosage form: INJECTABLE FOAM NCI concept code “C113106 The appropriate SPL web pages (e.g. []) and terminology validation files have been updated.
 * [18-Dec 2013] New SPL Dosage Form **

The following validation procedure for content of labeling/product data element SPL documents with information for designated medical gas products that have NDAs will be implemented **today, Thursday, December 5, 2013**: 4.2.1.9 If the document type is Human Prescription Drug Label (34391-3) or Prescription Animal Drug Label (50578-4) and the active ingredient is in the designated medical gas validation list, then there is at least one other content of labeling section besides those with the codes 48780-1 and 51945-4. Here is the hyperlink to the draft of the regulatory Guidance for Industry Certification Process for Designated Medical Gases: [].
 * [5-Dec 2013] New Validation Procedure for Designated Medical Gas Products w/NDAs SPL Documents **

New SPL terms and validation procedures were very recently implemented for registration SPL submissions which include the new business operation: Human Drug Compounding Outsourcing Facility. (Note: Here is a hyperlink to the recently posted draft of the regulatory Guidance for Industry: Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act [].) There are also new business operation qualifiers which should only be utilized if the business operation “Human Drug Compounding Outsourcing Facility” is used in the establishment registration SPL document. ( [].) Here is the hyperlink to the web page with the new business operation qualifiers associated with the new business operation “Human Drug Compounding Outsourcing Facility” (note: all of the new business operation qualifiers terms related to compounding include the word “compound” or “compounding.” []. Also, the appropriate terminology XML files have been posted for download on the SPL web page: []. Here are the new validation procedures related for establishment registration SPL documents which include the new aforementioned compounding-related terminology: 6.1.7.1 If the business operation is Human drug compounding outsourcing facility (C112113) then there are 3 operation qualifiers. 6.1.7.2 One of the qualifiers is Intent to compound 506e (drug shortage) drugs (C112087) or No intent to compound 506e (drug shortage) drugs (C112091). 6.1.7.3 One of the qualifiers is Compounding from bulk ingredients (C112092) or Not compounding from bulk ingredients (C112093). 6.1.7.4 If one of the business operation qualifiers is compounding from bulk ingredients (C112092) then one of the following business operation qualifiers should be included: Compounding sterile products (C112094), and Not compounding sterile products (C112095). 6.1.7.5 If one of the business operation qualifiers is Not compounding from bulk ingredients (C112093) then the following business operation qualifiers should not be included: Compounding sterile products (C112094), and Not compounding sterile products (C112095). 6.1.7.6 If the qualifiers Intent to compound 506e (drug shortage) drugs (C112087), No intent to compound 506e (drug shortage) drugs (C112091), Compounding from bulk ingredients (C112092), Not compounding from bulk ingredients (C112093), Compounding sterile products (C112094), or Not compounding sterile products (C112095), then the operation is Human drug compounding outsourcing facility (C112113). 6.1.7.7 There is no other qualifier
 * [5-Dec 2013] New SPL Terms & Validation Procedures Related to SPL Registration Files for Human Drug Compounding Outsourcing Facilities **

From FDA SPL group: Effective immediately, a validation procedure will be implemented to ensure that the DUNS Number associated with a US agent identified in an incoming establishment registration SPL document is linked to an address in the US.
 * [14-Nov 2013] New Validation Procedure: DUNS Number associated with US Agent must be linked to a US Address. **

National Library of Medicine (NLM) has recently added more web ports for its SPL/DailyMed Jamboree Workshop. To attend this free public workshop via web conference, please register utilizing the instructions accessible via this NLM web page: [].
 * [24-Oct-2013] Free Public Workshop - Oct 28 - the SPL/DailyMed Jamboree Workshop - Attend via web conference **

Until further notification, SPL technical support via the spl@fda.hhs.gov e-mail account will be handled for only FOUR hours each business day. Be aware that -- during to the absence of either FY2014 funding appropriation or Continuing Resolution for the Department of Health and Human Services, DailyMed may not be updated. Furloughs at the National Library of Medicine may delay posting of new and updated labels to DailyMed. During this time, all new and updated product SPL files eligible for posting publicly WILL BE made available via [|Labels.fda.gov].
 * GOVERNMENT FURLOUGHS ENDED **** [06-Oct-2013] During the government-wide furloughs, reductions in SPL technical support and timeliness of DailyMed may occur **

Remember - if you have an issue with the Pragmatic Data Validator Lite tool, please contact Pragmatic Data, LLC using their e-mail address spl@pragmaticdata.com.. The SPL group at the FDA does not fix or modify this tool, and you'll get a faster response by contacting the company (Pragmatic Data, LLC) supporting the tool
 * [15-September **** -2013] Pragmatic Data Validator Lite contact **

The FDA Data Standards Council's Structured Product Labeling web page has been updated to include a web page hyperlink to NLM's announcement of its SPL/DailyMed Jamboree Workshop: [].
 * [26-August **** -2013] SPL/DailyMed Jamboree Workshop - October 28, 2013 ** NLM is sponsoring a public meeting, “SPL/DailyMed Jamboree Workshop – Using DailyMed Drug Product Label Data”. Representatives from the brand name, generic name and OTC drug industries will speak, as well as the FDA, the NLM and possibly other government agencies. Information available here: []


 * [27-July **** -2013] New SPL Stylesheet now posted on Data Standards page at FDA ** The FDA Data Standards Council's Structured Product Labeling (SPL) web page has been revised to include an updated SPL stylesheet: [|http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm]

National Library of Medicine (NLM) has added a new feature to their DailyMed website. DailyMed users may now browse DailyMed by drug class. One may opt to show only results with the FDA Established Pharmacologic Class (EPC) or the Veterans Administration (VA) National Drug File – Reference Terminology (NDF-RT) classifications. Note: The EPC and NDF-RT drug class information is included pharmacologic class indexing SPL files which FDA transmits to NLM. Here is the link to the new DailyMed “Browse By Drug Classes” web page: [].
 * [03-July **** -2013] New DailyMed feature: Browse by Drug Class **

To ensure that authors of content of labeling/product data elements SPL documents are referencing at least one representative sample of cartons/containers per product in SPL files, a new validation procedure will be implemented. Since the majority of the SPL document authors are correctly referencing the representative samples of cartons/containers in the aforementioned SPL type, the following validation procedure **will be implemented within a few calendar days or less** because most of the incoming SPL files should not be impacted by this validation procedure (please note the exception): “With the exception of inner components of kits, for each product there is a representative sample image of a carton/container label in a major SPL section with section heading "Package.Label Principal Display Panel” (51945-4), except for Positron Emission Tomography drug products.”
 * [26-April **** -2013] Representative Sample of Cartons and Containers - Validation Rule **


 * [16-April **** -2013] Fragrances? Can you code them? ** if a fragrance is listed in a product’s drug facts’ inactive ingredients section, if the components of the fragrance are known and a UNII exists for each of the substances of which that fragrance is comprised, SPL creator could enter the preferred term and UNII for each substance. If the fragrance information is proprietary, the SPL author may just omit the reference fragrance information in the product data elements section of the SPL file. In the future, a field similar to SPLFLAVOR could be implemented. Submission of this information would be voluntary. There is no timeframe for addition of this type of new field.


 * [16-April **** -2013] OTC Monograph - Active Ingredient validation file reference now available ** The Excel and XML versions of the new OTC monograph – active ingredient terminology validation file referenced in the e-mail below is now posted on the FDA SPL web page.

In the near future, to ensure that all of the active ingredients in the product data elements section of an incoming SPL file with the marketing category “OTC monograph – Final” are associated with the OTC monograph citation referenced in that incoming SPL document, the following new validation procedure will be implemented: If the code is C73603 (OTC monograph final), then all active ingredient codes (if any) match an entry in the OTC validation-final-all list for that monograph citation (id extension).


 * [31-M **** arch-2013] SPL Indexing Fact Sheet available at FDA ** The Indexing SPL Fact Sheet has been posted under the FDA SPL web page subheading “Resources”: [].

As of March 10, 2013, FDA is aware of only **eight** SPL R3 files still posted on DailyMed. Those eight SPL R3 files have information for only eleven drug products. In past reports of outdated SPL R3 DailyMed data, there were hundreds or thousands of rows of data related to remaining SPL R3 files posted on DailyMed. Thanks to all of the SPL document authors, drug companies’ staffs, and SPL software vendors who were dedicated to ensuring that the VERY outdated SPL R3 SPL documents were removed or replaced on DailyMed.
 * [11-March-2013] Only 8 SPL R3 files left on DailyMed - down from 1000s ** Greetings, Note: SPL R3 files are those submitted to FDA prior to June 1, 2009. The SPL R3 files do not include data elements such as the application number, regulatory citation, marketing status, etc... Beginning June 1, 2009, FDA no longer accepted SPL data in the SPL R3 format and only SPL data in the SPL Release Four format was accepted.


 * [11-March-2013] Details on 8 SPL R3 files left on DailyMed - Please Assist! ** The Remaining R3 SPL files are listed below. If you have any information on the whereabouts of the sponsors or authors of these files, please let them know that the files need to be replaced or removed from DailyMed
 * NDC Product Code || Proprietary Name || Document Set Id ||
 * 59630-480 || Triglide || 65afa805-603a-43de-9651-d04e49bd2aa7 ||
 * 59630-485 || Triglide || 65afa805-603a-43de-9651-d04e49bd2aa7 ||
 * 0409-2025 || DOBUTamine || 7600f81c-0bdd-4e7e-cdb8-6c12080861a7 ||
 * 39822-3015 || Nystatin || a6c9583f-7cd4-4d17-800c-5ce9474b7523 ||
 * 0472-0082 || Acyclovir || a88d64ef-e6c9-4de0-b1fc-39c76ec4bd0c ||
 * 0472-1030 || Hydromet || afb8ebda-777b-4733-bf31-5b7ae32eeb85 ||
 * 42769-1380 || Hydrocortisone || aff90651-0f4e-45b8-99b8-9c71364949a2 ||
 * 42769-7781 || Promethazine HCl and Codeine Phosphate || aff90651-0f4e-45b8-99b8-9c71364949a2 ||
 * 0143-3126 || Dicyclomine Hydrochloride || baf1bea8-c573-4ef8-8630-7b51a8e53cac ||
 * 0338-0054 || Sodium Chloride || fb77dffc-b38d-461c-8926-bc57bef1f321 ||
 * 0338-0056 || Sodium Chloride || fb77dffc-b38d-461c-8926-bc57bef1f321 ||

As of close of business yesterday evening, there are 41,072 unique billing unit indexing SPL documents posted on DailyMed. Per a formal agreement between NCPDP and FDA, the billing unit update will occur once each month.
 * [13-February-2013] FDA posts 'billing unit indexing SPL' files on DailyMed ** 12-February-2013, the remaining billing unit indexing SPL files from the first batch were posted.

Billing unit indexing SPL files are generated by FDA utilizing data provided by members of the National Council of Prescription Drug Programs (NCPDP.) A short overview of NCPDP’s billing unit standard is accessible via this hyperlink: []. Included in each billing unit indexing SPL file is one unique NDC package code as well the appropriate billing unit (eaches, grams, or milliliters) which describes the quantity of the drug product associated with the NDC identified in the billing unit indexing SPL document. Since the three-segment NDC is included in both the product’s SPL file (the SPL document generated and submitted by drug companies) and the billing unit indexing SPL file, the data in the two aforementioned files can be automatically linked (using the NDC) once imported into a database. The initial transmission of the billing unit indexing SPL files to DailyMed included almost 18,000 individual indexing SPL documents. Over the next few business days, FDA plans to transmit approximately 5,000 billing unit indexing SPL files per day until the first batch totaling over 40,000 billing unit indexing SPL files are posted on DailyMed. When new or updated billing unit indexing SPL files are available, they will be transmitted within one business day to NLM for posting on DailyMed. Here is the hyperlink to the DailyMed web page with the downloadable package of billing unit indexing SPL documents: [].
 * [08-February-2013] FDA posts 'billing unit indexing SPL' files on DailyMed ** The first billing unit indexing SPL files were posted on DailyMed yesterday, Wednesday, February 6, 2013.


 * [10-January-2013] FDA 2013 Training Session Schedule now published ** Registrations will be taken starting January 21, 2013. Details on the training sessions and on how to register are available on WIKI ** training page ** and at the ** [|FDA] **

The [|XML version of the active ingredient/active moiety/basis of strength list] is now available on the FDA's SPL Resources web page for use by the SPL document authoring software vendors. The list will continue to be published in Excel format on the SPL web page.
 * [07-January-2013] Active Ingredient Validation Rule Implemented ** There is a new validation procedure for the active ingredient/active moiety/basis of strength data relationship: //"If the active ingredient is in the active-ingredient-active-moiety-validation-list, then the active moiety and basis of strength must be the corresponding active moiety and basis of strength respectively in this list, except if the document type is for bulk ingredient (53409-9)."//

On Friday, August 17, 2012, there were over 40,000 unique SPL files posted on DailyMed. This Wednesday, January 2, 2013, the latest DailyMed milestone: over **45,000** unique SPL files on DailyMed.
 * [02-January-2013] DailyMed tops 45000 unique files! **


 * [01-October-2012] SPL web page at FDA updated and new content added ** The FDA Data Standards Council’s SPL web page [|http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm] was updated on September 30, 2012, and October 1, 2012, to include the updated/new content described below:


 * 1) Reorganization of SPL web page
 * 2) Grouping of like documents (e.g. regulatory guidance documents) together
 * 3) Removal of link to downloadable terminology files - Replaced with new webpage section: SPL Terminology Files for Validation
 * 4) SPL Implementation Guide/Validation Procedures document **updated**
 * 5) SPL stylesheet **updated**
 * 6) SPL schema **updated**
 * 7) New terminology: New document types, business operations, and a business operation qualifier
 * 8) Resources section: Links to web pages with Comprehensive NDC SPL Data Elements File (NSDE) and SPL Software and Conversion Vendors web page
 * 9) SPL Xforms web page: Removal of information about older SPL Xforms. Updated to include GDUFA Self-ID SPL templates
 * 10) SPL terminology files for validation (new section) : active ingredient-active moiety/basis of strength, links to Cosmetic Product Category Codes and Device Product Classification web pages
 * 11) GDUFA Self-ID SPL instructions documents.

[23-August-2012] SPLIMAGE Workshop Minutes, SlideSets, FAQ now AvailableThe notes and slidesets from this workshop are now available here. This page also contains a link to some questions asked regarding solid oral dose formulation product images, and some answers where available here. If you have not already submitted samples to the NLM for image creation, consider doing so SOON. If you want to take images, or have images created through some other organization, remember to follow the [|SPLIMAGE specification].


 * [21-August-2012] Follow the SPL Implementation Guide!! **

//Greetings, SPL Community,//
Since 2005, FDA has encouraged companies to create SPL files which conform to the published SPL implementation guide. Over the years, validation procedures have been implemented when possible to notify authors of SPL documents when the SPL implementation guide has not been followed; however, files submitted to FDA prior to the implementation of a validation procedure may have been processed with for, example, an incorrect SPL XML code structure. There are several entities which are downloading the over 40,000 SPL files on DailyMed into their software tools and decision support systems that were designed based on the SPL Implementation Guide. We are receiving reports that, due to the incorrect code structure in some of your SPL files, the data may not be accurately represented when downstream users of the SPL files load the SPL data into their databases for queries, etc… We once again recommendation that you follow the SPL Implementation Guide when creating your SPL documents for submission to FDA. Thank you, Structured Product Labeling Team FDA Data Standards Council


 * [23-July-2012] SPL Working Group SPLIMAGE Workshop being held at NLM ** The SPL Working Group has gathered a group of sponsors, NLM and FDA staff involved with SPLIMAGEs, vendors, downstream users for a SPLIMAGE Workshop, to be held at the NLM Boardroom in Bethesda, MD on July 26, 2012, 10 AM to 4 PM.NLM has been working toward developing the methods and infrastructure for digital photographs of prescription oral solid dose medications (prescription pills, tablets, and capsules). A complete, comprehensive portfolio of the nation's prescription formulary would have a profound impact on consumer safety.On May 23, 2011, NLM posted a Federal Register Notice (Vol. 76, No. 99, FR Doc. 2011–12629, []), seeking sources of medications to develop the photographic techniques to capture this information.In June 2012, the first results of an ongoing study of digital photographs of voluntarily submitted medications by pharmaceutical manufacturers have been released. We will gather information about the process and techniques on digital photography and data acquisition, and discuss the further implementation, issues and opportunities of SPLIMAGEs. Topics to be discussed likely include:

While the meeting is an open forum of the SPL Working Group, space in the room is limited. Specific invitations have been made to a number of sponsors (including all those who provided samples in response to the May 2011 Federal Register notice), FDA representatives involved with SPL and the SPLIMAGE discussions, NLM representatives involved with the SPLIMAGE image production and dissemination, interested vendors and potential downstream users of the SPLIMAGEs as they become available. Outcomes from the discussions will be disseminated via the usual SPL Working group communication channels (SPL Working Group WIKI, cascades through e-mail, LinkedIn, presentations at SPL WG subteam meetings, and potentially others). If you have any questions about the meeting or if you would like to attend, contact the SPL Working Group Leadership Team through Terry Brunone (Theresa.M.Brunone@gsk.com).
 * Digital Photography of SPLIMAGE• Methodology• Results• Demonstration
 * Early Experience with the SPLIMAGE data ‐ Respondents to the NLM FR Notice• Sponsors perspective(s)
 * DailyMed & possible downstream uses
 * Workflow discussion
 * Use of the SPLIMAGE specification outside of NLM photography
 * Updated sample provision process?
 * Possible issues and concerns

The active ingredient/active moiety relationship validation procedure has been implemented. Any active ingredient/active moiety relationships published in the April 2012 list will be validated. The remaining active moieties will continue to be validated utilizing the counter-ion list. The NDC Labeler Code Inactivation and Establishment De-Registration SPL document types may now be utilized. Prior to using the NDC Labeler Code Inactivation document type, please ensure that you have discontinued all products with NDCs which include the NDC Labeler Code you are attempting to inactivate.
 * [17-July-2012] FDA activates active ingredient/active moiety validation rule, adds doc types **


 * [05-July-2012] FDA issues Proposed Rule on UDI System - includes possibility of using SPL ** Proposed rule link: []pg 83:Data could be submitted as part of a structured product label (SPL) conforming to an ANSI/Health Level Seven (HL7) format (Ref. 7) that meets specifications set by FDA; we believe this is the approach most larger labelers would prefer, as it is based on an existing international standard that is already used for submission of data to FDA, and can readily accommodate the efficient submission of multiple records.


 * [01-July-2012] Implementation of Validation Procedure for the Product-to-Establishment data relationship ** Per CDER, the implementation of the validation procedure for the product-to-establishment data relationship for CDER-regulated drug products is scheduled for Sunday, July 1, 2012.

The first SPL file with an International Society of Blood Transfusion (ISBT) code was posted on DailyMed during the afternoon of Friday, June 29, 2012. Here are hyperlinks to the SPL file: DailyMed: [] Labels.fda.gov: [] Note: The "ISBT" code (facility ID and a product code) is located in the product data elements section "field" where the NDC package code would normally appear. Please note that the omission of a code in the product code field is intentional.
 * [29-June-2012] First file with ISBT code posted on DailyMed **


 * [26-June-2012] First SPLIMAGE posted on DailyMed **

The first SPL file with an SPLIMAGE (image of an oral solid dosage form product) was posted on DailyMed during the afternoon of Tuesday, June 26, 2012. Here is a hyperlink to the SPL file: [].

Note: The product's image is rendered adjacent to the product data elements section with the description of the product.


 * [14-June-2012] Specification for SPLIMAGE (solid oral dose images) now available ** The DailyMed site now has a link to the SPLIMAGE Specifications: []


 * [10-June-2012] New download selections from DailyMed **

National Library of Medicine has improved its DailyMed download feature by providing more options for entities which download SPL files from DailyMed. A. Periodic Updates 1. Daily 2. Monthly 3. Weekly B. Full Releases (Note: "//The full human prescription and OTC archive files, **dm_spl_release_human_rx.zip** and **dm_spl_release_human_otc.zip**, are no longer available due to size considerations. Instead, these archives have been split into multiple parts.")// Here is a hyperlink to the updated DailyMed SPL files download web page: [].

The FDA Substance Registration System team has made a decision to deprecate three "carbomer" UNIIs and rename two of the remaining "carbomer" UNIIs.
 * [08-June-2012] Changes to CARBOMER terms and UNIIs: **

To minimize the shock of these changes, at least one former preferred substance name will be allowed in product data elements section. The additional names are provided below following the preferred substance name.


 * CARBOMER UNIIs REVISED**

F68VH75CJC CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) ....CARBOMER HOMOPOLYMER TYPE A 4Q93RCW27E CARBOMER HOMOPOLYMER TYPE B/C (ALLYL PENTAERYTHRITOL CROSSLINKED) ....CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)

....CARBOMER HOMOPOLYMER TYPE C Z135WT9208 CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED) ....CARBOMER 934 71DD5V995L CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)

....CARBOMER COPOLYMER TYPE A 809Y72KV36 CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) ....CARBOMER 1342


 * DEPRECATED UNIIs** 1G56KV7BUJ HHT01ZNK31 K61870Z308

A. Schedule for Deprecation of the LOINC Name "SPL Listing Data Elements Section" 1. Date of implementation/discontinuation: June 1, 2012 2. Date of announcement: December 18, 2011 B. Translation Element in SPL Package Description - Discontinuation of Use Notification 1. Date of implementation/discontinuation: June 1, 2012 2. Date of announcement: January 31, 2012 C. Revision to Name of Document Type for Labeler Code SPL 1. Date of implementation/discontinuation: ~June 30, 2012 2. Date of announcement: April 29, 2012 I've included copies of the e-mailed notifications below.
 * [30-May-2012] Upcoming implementation & discontinuation dates: ** A reminder of implementation or discontinuation plans scheduled to occur in June 2012.


 * [25-May-2012] E-Labels now available via DailyMed and FDA Online Label Repository ** **"Availability of up-to-date electronic labels on DailyMed and FDA's new FDA Online Label Repository**"Within one business day, drug companies may now update their electronic content of labeling on [|DailyMed] and the [|FDA Online Label Repository]."


 * [14-May-2012] New Section Header: HCP Letter ** The FDA Data Standards Council’s website was updated Friday, May 11, 2012, to include the following updates: 1) New Section header: Health Care Provider Letter Section - [|http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162057.htm]2) Updated terminology XML files - [|http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm169455.htm]

Per CDER, the implementation of the validation procedure for the product-to-establishment data relationship for CDER-regulated drug products is scheduled for Sunday, July 1, 2012. The FDA Data Standards Council’s website was updated Tuesday, May 8, 2012, to include updated terminology: 1) New marketing category: unapproved drug for use in drug shortage - [|http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162528.htm] 2) Updated XML terminology Files (marketing category) - [|http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm169455.htm]
 * [08-May-2012] New Product-to-Establishment Data Relationship for CDER Drug Products: JULY 1, 2012 **
 * New Marketing Category **

Beginning **Monday, May 21, 2012**, we will be offering 1:1 (FDA SPL Team & SPL document author) **15-minute** SPL Technical Q&A sessions. These SPL Tech Q&A teleconference 15-minute sessions will afford an opportunity for a company representative to attend an SPL Tech Q&A session to ask SPL technical questions at a scheduled time agreed upon by the FDA SPL team and a company representative. The Monday SPL Tech Q&A group sessions will still be held and questions may still be e-mailed to spl@fda.hhs.gov. Registration for these sessions begins on **Monday, May 21, 2012**. Registration requests for these sessions received **prior** to Monday, May 21, 2012, will receive a response which includes a note about the May 21, 2012, start date. To request a session, **please** follow these instructions: Send an e-mail to spl@fda.hhs.gov with the following information: 1. Name of company 2. Name of contact person 3. Time Zone 4. Country 5. List of SPL technical questions Following these instructions will ensure that the SPL team can efficiently respond to and schedule SPL Tech Q&A 1:1 teleconferences as soon as possible.
 * [07-May-2012] New from FDA - 15 minute 1-on-1 sessions between company rep. and SPL Team **
 * Subject line of e-mail:** Request for 1:1 SPL Tech Q&A 15-Minute Session - [Company Name]
 * Body of e-mail:**
 * Reminder:** Registration for these sessions begins on **Monday, May 21, 2012**.

The document type "NDC Labeler Code Request" has been changed to "NDC/NHRIC Labeler Code Request." The LOINC code for this document type will remain as 51726-8. Until approximately **June 30, 2012**, both "NDC Labeler Code Request" and "NDC/NHRIC Labeler Code Request" names will be accepted for **incoming** labeler code SPL submissions. After approximately **June 30, 2012**, only "NDC/NHRIC Labeler Code Request" will be accepted for **incoming** labeler code SPL submissions.
 * [30-Apr-2012] Change in documenty type "NDC Labeler Code Request" - Action needed by June 30, 2012 **

DailyMed was updated to add a hyperlink to permit the download of all of the pharmacologic class indexing SPL files which have been transmitted to NLM. Newly indexed vaccine pharmacologic class files should be included in this new pharmacologic class SPL file downloadable file.
 * [10-Apr-2012] Hyperlink to download Pharmacologic Class info now available from DailyMed **

The link is accessible via: Options-> “Downloads” -> “Download All Pharmacologic Class Indexing SPL files."

At this time, the list is only available in Excel format. Once the validation procedure for the active ingredient-active moiety relationship has been implemented, the XML version of this list (which may only contain the UNIIs for the active ingredients and active moieties whose relationships have been defined) will be published. The current list contains over 13,000 active ingredient-active moiety relationships. This list will be updated as often as possible to include new active ingredient-active moiety relationships. SPL files currently posted on DailyMed with **incorrect** active ingredient-active moiety relationships should be updated to include the correct active moiety. A manual override will be necessary to process the updated SPL file.
 * [09-Apr-2012] Active Moiety Errors? Check this spreadsheet! ** To reduce the amount of incorrect active moiety entries in SPL files, a list of active ingredient-active moiety relationships has been posted on the SPL web page accessible via this hyperlink: [].

1) Quarterly update of the SPL Implementation Guide/Validation Procedures document - [] 2) New Active Ingredient-Active Moiety Relationship List - [] 3) New SPL terms:a.) Section headers (e.g. diagram of device) - [|http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162057.htm] b.) Document types (e.g. Establishment De-registration) - [|http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162063.htm] c.) Marketing category (e.g. dietary supplement) - [|http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162528.htm] 4) Updated terminology XML files - [|http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm169455.htm]
 * [08-Apr-2012] IG/VP Update + new SPL Section Headers, Document types, Marketing categories ** The FDA Data Standards Council’s website was updated Sunday, April 8, 2012, to include the following updates:


 * [14-Mar-2012] 35000 unique SPL files on DailyMed! ** As of Wednesday, March 14, 2012, there are over 35,000 unique SPL files posted on DailyMed.


 * [13-Mar-2012] Search via setid on DailyMed ** The National Library of Medicine has recently updated its DailyMed website ([]) to include an option to search via an SPL file's set ID.

1) New Flavor (Ginger) - [|http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162541.htm] 2) New Dosage Form (Cellular Sheet) - [|http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162038.htm] 3) Updated terminology XML files [|http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm169455.htm]
 * [06-Mar-2012] Data Standards Council site updates: new flavor, new dosage form, updated XML files ** The FDA Data Standards Council’s website was updated Friday, March 2, 2012, and Tuesday, March 6, 2012, to include updated terminology:

The FDA Data Standards Council’s website's SPL web page was updated Friday, February 17, 2012, to include an updated SPL schema (SPL Release Five.) [|http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm]
 * [23-Feb-2012] Updated SPL Schema **

This update includes: 1. Correction to the font (bold) and capitalization of the "Section 17" verbatim statements in the highlights text. 2. Removal of rendering of rendundant multi-level package description information in the product data elements section. 3. New feature: View the document's ID, set ID, version number, and effective time by placing the computer's mouse cursor over the revision date in the bottom left corner of an SPL document. Questions about this stylesheet should be directed to spl@fda.hhs.gov.
 * [13-Feb-2012] Updated SPL Stylesheet ** The FDA Data Standards Council’s website's SPL web page was updated Monday, February 13, 2012, to include an updated SPL stylesheet: []


 * [09-Feb-2012] New mobile app for DailyMed ** [] NLM ® released DailyMed ® Mobile on January 31, 2011. [|DailyMed mobile] features a simplified design enabling easy search, retrieval and display of SPLs from any Web-enabled mobile device. Users can also e-mail SPLs to themselves or colleagues for later viewing on other platforms.

Beginning on **Wednesday, February 15, 2012,** you may submit SPL files without the translation element/unit of presentation in the product data elements section's package description. Beginning **Friday, June 1, 2012**, SPL documents with the translation element (e.g. < translation code =" C61569 " codeSystem =" 2.16.840.1.113883.3.26.1.1 " displayName =" BLISTER PACK " value =" 100 "/>) in the package description section will fail validation.
 * [01-Feb-2012] Translation Element no longer necessary in the unit of presentation **

The FDA Data Standards Council’s website was updated Friday, December 30, 2011, to include the schedule for the 2012 SPL training sessions: @http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm155705.htm .
 * [03-Jan-2012] Schedule and Registration for FDA SPL Training Sessions **

2) New marketing categories - @http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162528.htm a) Bulk Ingredient For Animal Drug Compounding b) Bulk Ingredient For Human Prescription Compounding c) Cosmetic 3) New document/content of labeling types - @http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162063.htm a) Prescription Medical Device Label b) OTC Medical Device Label 4) Updated terminology XML files @http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm169455.htm
 * [03-Jan-2012] New codes for content sections, marketing categories, document types, + updated terminology files ** 1) New section headers - @http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162057.htm a) Health Claim Section b) Patient Medication Information Section c) Pharmacogenomics Section d) SPL Product Data Elements Section e) Statement of Identity Section

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

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: [] 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): [] 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. 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.** 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] 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.
 * 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 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: []

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

[|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.
 * [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: