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Frequently Asked Questions
About SPL (Structured Product Labeling)

This section highlights the questions relevant to both SPL R3 and SPL R4. For FAQs specific to R4, the release of SPL that has been required since June 2009, see Frequently Asked Questions About SPL R4.

FDA Style Implementation

Why does the formatting of the converted label not match the source file I supplied?

Why does the position of table titles in the converted label not match the source file I supplied?

Why do you add lines above and below tables?

Why does the position of figure captions in the converted label not match the source file I supplied?

Why do the emphasis and alignment of section titles in the converted label and/or the casing of text in the section titles, not match the source file I supplied?

Why is the converted label missing some special characters, symbols, or emphasis?

Why is text I included for an ingredient missing from the Drug Product Listing table—for example, why does "water for injection" appear as just "water"?

Why are some of the images unclear?

When viewing the converted label in an Internet browser, why do line breaks not match the source file I supplied?

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Posting/Receiving Files and Reviewing Your Converted Label

What files does DCL need to convert my label?

What are my options for transmitting my files to DCL?

I’m having difficulty opening and viewing the files you sent me. What do I do?

What files does DCL include in the review package and how do I use them?

How do I request revisions to a label that has or has not already been submitted to the FDA?

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Submitting Your Label to the FDA

How do I submit a label to the FDA?

What files do I submit to the FDA?

If I submit only the XML file and one set of images, why does DCL send me additional files?

Do I send the SPL Document Summary report to the FDA?

Do I send the DCL Guide for Reviewing a Converted SPL Label to the FDA?

Do I send the Client Review of Converted SPL Label form to the FDA?

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Useful SPL Resources

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Frequently Asked Questions
About SPL R4
(Structured Product Labeling Release 4)

This section highlights questions specific to SPL R4, the newest release of SPL. For FAQs concerning Drug Product Listing/Content of Labeling, see Frequently Asked Questions About SPL.

General

What is new in SPL R4?

If I've been filing in SPL, and nothing in my label has changed, neither drug listing information nor content of labeling,do I need to file in SPL R4?

I just did my annual Establishment Registration filing using a paper 2656, can I get started in SPL R4 by submitting a new label?

I have heard the FDA offers a tool for companies to validate SPL submissions before submitting files through the electronic gateway. Is it reliable, and how do I use it?

How do I delist a drug using SPL?

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Establishment Registration

What information is required for electronic Establishment Registration?

How do I go about getting DUNS Numbers for my establishments?

I am a labeler but do not own any manufacturing facilities. Do I need to register, as well as file an NDC Labeler Code Request?

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Useful SPL Resources

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FDA Style Implementation

The primary concern of the SPL initiative is content, not formatting.

Q. Why does the formatting of the converted label not match the source file I supplied?

A. The formatting you see results from applying the FDA stylesheet. The stylesheet is subject to change. DCL will ensure that your labels comply with the current stylesheet.

Q. Why does the position of table titles in the converted label not match the source file I supplied?

A. The FDA stylesheet always places a centered title, in boldface, above a table. The SPL schema does not allow line breaks in titles. As a result, the stylesheet places as much text as can fit on each title line.

Q. Why do you add lines above and below tables?

A. The FDA stylesheet places lines above and below a table as displayed in your converted label.

Q. Why does the position of figure captions in the converted label not match the source file I supplied?

A. The FDA stylesheet places a centered caption, in boldface, below a figure. The SPL schema does not allow line breaks in captions. As a result, the stylesheet places as much text as can fit on each caption line.

Q. Why do the emphasis and alignment of section titles in the converted label, and/or the casing of text in the section titles, not match the source file I supplied?

A. FDA Best Practices recommend that you allow the stylesheet to control the appearance of section titles and, therefore, discourage explicit coding of emphasis in section titles. The FDA stylesheet always left-aligns section titles and applies emphasis (boldface or italics) and casing based on the heading level. Unless expressly instructed by you, DCL exercises its best judgment to identify section titles and to apply emphasis when needed. For example, for italicized Latin phrases, such as in vitro, in a heading, emphasis will be retained. Also, in the XML, the casing of text in titles is retained as it appears in the original label; the FDA stylesheet may change the appearance of the casing, but the underlying XML has it as it is in the original.

Q. Why is the converted label missing some special characters, symbols, or emphasis?

A. You can have special characters and symbols, such as the Registered Trademark (®), Trademark (™), and Copyright symbol (©), in the text and titles of your label, but the FDA does not allow them in the SPL Drug Product Listing (DPL). As a result, such special characters and symbols do not appear in the rendering of the DPL.

Special characters, symbols, or emphasis (including superscript and subscript) — while present in the label body in the XML file — may not appear when you print a converted label. To verify that characters, symbols, or emphasis are in the XML file, view the file on screen in either an Internet browser or an editor.

Q. Why is text I included for an ingredient missing from the Drug Product Listing table—for example, why does "water for injection" appear as just "water"?

A. In the Drug Product Listing (DPL) part of the SPL, which is intended for computer processing rather than printed output, the FDA uses only the name of the ingredient, with no description. DCL edits the data in the DPL to conform to instructions received from the FDA, dropping the following descriptive terms from ingredients:

· for injection

· may contain

· may include

· NF

· Purified

· Sterile

· q.v.

· USP

· v/v

· w/v

· WFI (becomes “water”)

· %s (for example, “Alcohol 5%” becomes “Alcohol”)

This list is subject to change based on further instructions from the FDA.

In the narrative sections, such as “Description,” which appear in printed output, the text for ingredients remains as you provide it, including descriptions.

Q. Why are some of the images unclear?

A. DCL provides you with three sets of images at different resolutions, in different folders. The images provided in the same folder as the XML generally fit well on the screen, but may sometimes be unclear.

In addition to the default set, we provide the following higher resolution versions of the images:

· Medium resolution (150dpi) in folder images-medres. At this resolution, images will be clearer than at the default resolution and generally fit well on screen and on paper. You may prefer these images.

· High resolution (300dpi) in folder images-highres. The image quality is high, but when viewing and printing, the images appear much larger than in the source, sometimes exceeding the page margins. We provide this resolution in the event medium resolution is still not clear.

FDA wants images to be, at a minimum, large enough to read when printed, and small enough to fit within the margins of the page. When selecting an image for final submission to the FDA, be sure it meets those two criteria.

When viewing or printing a converted label, if an image is unclear, first copy the image from the images-medres folder to the folder that contains the XML file, and then reload the XML file. If the image is still unclear, copy it from images-highres. We expect that image will be readable, but be sure it’s within the margins of the page.

You submit only one version of each image to the FDA. You can submit different images at different resolutions, but are limited to only one resolution per image.

Q. When viewing the converted label in an Internet browser, why do line breaks not match the source file I supplied?

A. The browser determines line breaks based on the size of your browser window and the text size. To achieve the desired line breaks, try the following:

· Resize your browser window.

· From the View menu, highlight Text Size and choose a smaller size. For example, if your text size is Large, try Medium instead.

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Posting/Receiving Files and Reviewing Your Converted Label

Q. What files does DCL need to convert my label?

A. To convert your labels, DCL asks you to provide the following files:

· A source document in one of the following formats: Microsoft Word, Quark, PDF (normal), or PDF (image/paper/fax).

Each of these documents represents a different pricing model. For details, contact Don Bridges: DBridges@dclab.com.

· If your source document is in Word or Quark, please supply a PDF version, in addition to your Word or Quark file.

· Optionally, you can submit individual image files. DCL crops images from the source PDF, so you do not need to provide images separately.

If you choose to submit images separately, please ensure that they are true JPEG images.

· A completed Drug Product Listing (DPL) spreadsheet. DCL provides you with this spreadsheet at the start of your conversion project.

Q. What are my options for transmitting my files to DCL?

A. You can transmit files to DCL in the following ways:

· Email your documents to DCLSPL@dclab.com.

· Using FTP, upload your documents to the DCL FTP site. You will need a DCL FTP account. DCL provides you with this account information at the start of your conversion project.

If you do not have an account and would like one, or if you need information about your existing account, send your request to DCLFTP@dclab.com.

· Using Secure FTP (SFTP), upload your documents to the DCL secure FTP site. To use this option, you will need FTP client software that supports SFTP, such as FileZilla, which you can download free from SourceForge.

In addition, you will need a DCL FTP account. DCL provides this account information at the start of your conversion project.

To access the DCL FTP server securely using your account, you must have firewall ports PASV 3500-3510 open. If you cannot access your account, contact your IT department.

If you do not have an account and would like one, or if you need information about your existing account, send your request to DCLFTP@dclab.com.

· Place your documents in a secure drop box at your site. To enable DCL to pick up your files, please provide a link to your drop box and the user ID and password for DCL to use. When your files are ready for pickup, please notify DCLSPL@dclab.com.

Q. I’m having difficulty opening and viewing the files you sent me. What do I do?

A. To open and view the files:

1. Using WinZip or a similar tool, extract (unzip) all files, making sure that you check the Use folder names option. DCL has set up the folder structures within the ZIP file to facilitate submission of the SPL to the FDA and for easy availability of the three sets of images we provide.

2. Open Internet Explorer and, from the File menu, choose Open

3. In the Open dialog box, click Browse and then navigate to the directory where you extracted the files.

4. In the Files of type field, choose All Files.

5.        In the resulting list, click the XML file you want to open (drugname.xml), and then click OK.

•  Click Yes if you get the message "This page is accessing information not under its control. ... Do you want to continue?"

•  See below if you get the message:
The XML page cannot be displayed ...
Access is denied. Error processing resource 'http://www.fda.gov/oc/datacouncil/stylesheets/spl/spl.xsl'

6. If the text displayed in Internet Explorer is very large, from the View menu, highlight Text Size and Medium to ensure that text on the right-hand side of the page is not truncated when printing.

            If you get the message: "The XML page cannot be displayed ...
Access is denied. Error processing resource
http://www.fda.gov/oc/datacouncil/stylesheets/spl/spl.xsl,"
your security setting in Internet Explorer is not allowing the SPL to render because it requires the stylesheet on the FDA web site.

In the above case, you will need to check with your IT department if you can change the setting. If you can change the setting, do so as follows:

1.   Go to Tools -> Internet Options
2.   Click on the Security tab
3.   If the Local intranet icon in the top of the window is not highlighted,
      click on it
4.   Look in the bottom half of the window, headed Security level for this
      zone. Move the slider to Medium-low (one position up from the
      bottom).

Q. What files does DCL include in the review package and how do I use them?

A. For your review of a converted label, DCL provides you with a zip file that contains:

· An SPL folder that holds the converted label (drugname.xml) and low-resolution (72 dpi) images.

For review purposes, most clients use these images for submission. At this resolution, images fit well on screen and on paper. For this reason, this is the default resolution you will see when viewing your converted label. The image quality is acceptable for viewing, but may sometimes be unclear.

In addition to the default set, we provide the following higher resolution versions of the images:

You submit only one version of each image to the FDA. You can submit different images at different resolutions, but are limited to only one resolution per image.

· The SPL Document Summary, loinc-ref-drug.htm, which contains two reports that DCL generates for Quality Assurance testing of section levels and section reference links. In addition to reviewing these reports, DCL carefully checks each section and manually verifies that each section reference link is correct. DCL provides you with these reports to facilitate your review of the converted label.

For each section, the Section report lists the title, ID, level, LOINC code, and LOINC display name. Use this report to quickly verify section levels against the hardcopy.

For each section reference, the Link report lists the link ID, a code that indicates the result of a computer check of the link, the link text, and the title or first few words of the link target. Use this information for your own section reference link testing.

· The DCL Guide for Reviewing a Converted SPL Label, which explains what you need to know about the appearance of your converted label. The Guide itself is rendered using the SPL stylesheet. Refer to this guide when you review your converted label.

· A Client Review of Converted SPL Label form. Use this form to relay your review comments to DCL. DCL will respond to each of your comments and return the form with subsequent reviews.

Q. How do I request revisions to a label that has or has not already been submitted to the FDA?

A. To revise your labels, DCL asks you to provide the following files and/or documentation:

· Previous version of XML - If previous is on the Dailymed, provide the label that is on the Dailymed. If it is not on the Dailymed, provide the SPL to be revised. (i.e. that was submitted to the FDA)

· Indicate changes to label - Either provide a new version of the word document, or PDF, with tracked changes or an itemized list of the changes.

· New version of label – Clean version of the label with no changes noted or tracked.

· If any information has changed to the DPL Table (Table at the end of the XML, eg. Container Type, Active Moiety) then a New DPL.xls is needed.

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Submitting Your Label to the FDA

Q. How do I submit a label to the FDA?

A. All listing submissions are done using the FDA Gateway. Instructions are found here. Regardless of the type of submissions, the SPL will be in its own folder, containg only the SPL file and its images.

Establishment registration, NDC labeler code requests, and drug registration and listing submissions are sent to center "OC" and type of submission set to "SPL".

Approval submissions are sent as part of the eCTD.

Q. What files do I submit to the FDA?

A. You need to submit only the XML file and one version of each image file. DCL provides you with three sets of images at different resolutions:

· Low resolution (72dpi), included in the SPL folder, ready for submission. At this resolution, images fit well on screen and on paper. For this reason, this is the default resolution you will see when viewing your converted label. The image quality is acceptable for viewing, but may sometimes be unclear.

· High resolution (300dpi). This is the resolution recommended by the FDA. The image quality is better, but when viewing and printing, the images appear much larger than in the source, sometimes exceeding the page margins. This larger size is not a problem as these converted labels are intended for display in an Internet browser, which does not enforce page margins.

You submit only one version of each image to the FDA. You can submit different images at different resolutions, but are limited to only one resolution per image.

Q. If I submit only the XML file and one set of images, why does DCL send me additional files?

A. The additional files you receive in your review package are designed to facilitate your review of the converted label. These additional files include:

· The SPL Document Summary, loinc-ref-drug.htm, which you can use during your review to verify section levels and section reference links.

· The DCL Guide for Reviewing a Converted SPL Label, which explains what you need to know about the appearance of your converted label.

· A Client Review of Converted SPL Label form, which you use to relay your review comments to DCL.

Do not send any of these supplementary files to the FDA.

Q. Do I send the SPL Document Summary report to the FDA?

A. No. You need to submit only the XML file and one version of each image file. Do not send the SPL Document Summary report to the FDA.

Q. Do I send the DCL Guide for Reviewing a Converted SPL Label to the FDA?

A. No. You need to submit only the XML file and one version of each image file. Do not send the DCL Guide for Reviewing a Converted SPL Label to the FDA.

Q. Do I send the Client Review of Converted SPL Label form to the FDA?

A. No. You need to submit only the XML file and one version of each image file. Do not send the Client Review of Converted SPL Label form to the FDA.

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Information About R4

Q. What is new in SPL R4?

A.        For pharmas, SPL is now used for establishment registration (in place of Form 2656) and NDC Labeler Code Requests. Also, for label submissions, the following is now required:

-        establishment and marketing information,
-        UNII codes for ingredients, and
-        jpeg images of the representative sample of package labels and the text of their principal display panels, in place of the representative sample of the packaging that you previously supplied with drug product listing submissions.

For animal drugs, OTC products, and biologic products, everything is new, as they are first being required to file in SPL.

For all companies filing SPL R4, submissions now are done through the electronic gateway. If you don't already have a gateway account account, you need to apply for one; see the home page for the FDA Electronic Submissions Gateway (ESG) (Home Page)

There are also technical changes to the XML tagging used for SPL, but that is DCL's responsibility, and we'll spare you the details.

Q. If I've been filing in SPL, and nothing in my label has changed, neither drug listing information nor content of labeling, do I need to file in SPL R4?

A. You do not need to file the label in SPL R4 if nothing has changed. Electronic registration of your establishment, if you own manufacturing facilities, and labeler code is still required.

Q. I just filed my annual Establishment Registration filing using a paper 2656, can I get started in SPL R4 by submitting a new label?

A. No, a label can be submitted in R4 only after the manufacturing company for the drug and the NDC labeler code have been registered electronically. Note that your existing NDC labeler code must be registered electronically.

Q. I have heard the FDA offers a tool for companies to validate SPL submissions before submitting files through the electronic gateway. Is it reliable, and how do I use it?

A. The FDA offers a tool called Pragmatic Validator Lite, that is based on the validation tool the FDA uses to validate SPL files. The Validator Lite tool catches about 95% of the errors that would be caught by the FDA's own tool. The other 5% are the ones that are caught only by having access to the FDA's own databases.

The tool can be used on the SPL file itself, or on a zip file. The zip file should contain the complete contents of the folder to be submitted through the gateway.

In our experience, Validator Lite is excellent, and we use it as a final check, after our other qc processes. We recommend that you submit the zip file with the contents of the folder to the validator rather than the SPL alone when testing a listing submission. Even if your SPL file is clean, submitting it alone will produce an error message because the validator will not be able to verify that the images are included. The validator testing a zip file will be able to verify that the images are present, and will also report an error if there are any extra files (more than one xml, images not referenced by the SPL, any files other than *.jpg and *.xml), all errors that would prevent acceptance of the folder submitted through the gateway when submitted to the OC as an SPL submission.

We recommend that if you use the validator, you test it with a zip file, but do not submit the zip file through the gateway. Only a folder with one xml and the needed jpg files is to be submitted for the SPL using the gateway..

The Validator Lite site is http://validator.pragmaticdata.com/validator-lite/validator/spl/.

Q. How do I delist a drug using SPL?

A. If the drug has not beeen electronically listed (meaning you have not done a listing submission using SPL R4 through the gateway), the FDA requires that you first list the drug. Create an SPL, including the contents of labeling, and submit through the gateway. This will list the drug.

For drugs that are electronically listed, you submit a revised SPL file through the gateway. Complete our R4 spreadsheet, marking the product in the marketing section as Completed and giving both the start marketing date and the end marketing date (the date of expiration of the last lot manufactured) in the row for start marketing date.

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Establishment Registration

Q. What information is required for electronic Establishment Registration?

A. For electronic Establishment Registration, the following information is requested by the FDA:

· Document Information

– Effective Time

·         Registrant

     – Name
     – DUNS Number

·         Registrant Contact

     – Name
     – Mailing Address
     – City
     – State
     – Country
     – Postal Code
     – Telephone Number
     – Email Address

For each establishment, enter information for the establishment itself, and for a single contact for the establishment, as shown here:

·         Establishment

     – Name
     – DUNS Number
     – FEI
     – Street Address
     – City
     – State
     – Country
     – Postal Code
     – Type of Operation(s)

·         Establishment Contact

     – Name
     – Mailing Address
     – City
     – State
     – Country
     – Postal Code
     – Telephone Number
     – Email Address

Q. How do I go about getting DUNS Numbers for my establishments?

A. First check if the establishment already has a DUNS Number. In many cases, establishments will have multiple DUNS Numbers. In those cases, pick one to use for the registration. When using an existing DUNS Number, be sure the DUNS Number information is correct.

Dun & Bradstreet (D&B) offers the expedited DUNS® Request Service. By accessing this service, you will be able to request DUNS® Numbers for business establishments, suppliers, U.S. agents, or importers.

To initiate your request, go to the DUNS® Request website and following the instructions: http://www.dnb.com/dunsrequest

The DUNS® Request Service is available for a fee of $14.95 per establishment look-up and does not require a commitment to a D&B subscription. All charges will be applied to a customer provided credit card.

DUNS® Number requests are generally fulfilled within 10 business days after submittal for U.S. companies and 20 business days for companies located outside the U.S.

For more information on DUNS Numbers for FDA use, see
FDA DUNS Guide_09 09 2008.pdf

Q. I am a labeler but do not own any manufacturing facilities. Do I need to register, as well as file an NDC Labeler Code Request?

A. You electronically file only an NDC Labeler Code Request. Pharmaceutical companies and private label distributors that do not own any manufacturing facilities do not file Establishment Registrations, establishment registrations are done only by companies with manufacturing facilities.

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