Duplicate equivalent product is not allowed, it is deleted to avoid cyclic reference. Please enter correct data.Outer package in package group is the innermost package in the real world, you can check in SPL View.Outer package in package group is the innermost package in the real world, you can check in SPL View.You must provide your electronic signature in the preceding field. An electronic signature is any symbol attached to or logically associated with this submission executed by you with the intent to sign this submission and the above statement.

Pragmatic Structured Product Labeling Editor ("SPL XForms")

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Download / SaveResetValidateSubmit to FDASubmit to FDAFetchUploadFetch UNII

HeaderProductData ElementsTextContent Of LabelingViewSPL ViewClipboardResultXML ViewHelp Show Metadata This is related to Medicated Feed Mill
New Updates
  1. Click here to know more details on NDC code scheme and barcodes.
  2. "Save" and "Save In" buttons will no longer be available. Use Download File button instead which downloads the file at browser's default download location packaged as zip file.
  3. If your SPL has images, ensure to package the xml and images in a zip before loading and Ensure to have image file extension in small case eg. ".jpg".

To begin, load an existing file or select template and press the "Load Template" button. When creating a new file, begin by choosing a template that most closely matches your use case.

Technical Notes
  • Note on Browser Comparability: The Pragmatic forms work with Mozilla Firefox (6 and higher), Internet Explorer (IE7 and higher), Google chrome (8 and higher) and Apple Safari (4 and higher). We recommend to use Mozilla Firefox and Google Chrome for better performance.

  • Note on performance for first time use: While using the forms for the very first time, the forms may take some time to load and certain operations can be slow. This is due to one time initialization cost for the forms.

  • Note on Submit to FDA Button: Submit to FDA is used for submission of SPL file through Pragmatic ESG Gateway. Before submission, we recommend to validate the file with the help of Validate button to resolve the errors and then try to submit the file. Please note that for document types No Change Notification(53410-7) and Out Of Business Notification(53411-5), Submit to FDA is not supported. We recommend to resend the past Establishment Registration instead of No Change Notification.

  •  
      error -   
    "Internet Explorer Running Slow" Warning

    To avoid, Internet Explorer running slow warning. For some operations, internet explorer may give a warning message - "A script on this page is causing Internet Explorer to run slowly..." To avoid this message, download and save this link. Execute it from this link itself or execute the downloaded file using mouse double click. Try form operations after restarting Internet Explorer. Note that this needs to be done only once.

Usage
  • Tabs exist to split the form up and make it easier and faster to navigate.

    1. The header tab is general document information.
    2. The Data Elements tab is for product and indexing data elements.
    3. The Content of Labeling tab is for the document text sections.
    4. SPL View shows how the currently created SPL will look in the browser.
    5. XML View is the full XML of the SPL and allows editing the XML directly.
    6. Compare is for comparing 2 SPLs.
    7. Help is this tab you are currently looking at.
    8. Result tab will appear to show result of user actions such as validation or sending mail to FDA.

  • Collapse and expand form groups using the fat arrows shown on the top-left margin of collapsible groups. An arrow to the right (►) means a group is currently collapsed, click on it to expanded the group. An arrow downward (▼) means the group is currently expanded and can be collapsed by clicking on this arrow. Some key information about the group's content is displayed on the group title, as well as function buttons (see below). The group may expand on click of a function button depending on the operation corresponding to the function button.

  • To edit the files, you can type into any text field, drop down field (with direct type option) or auto-complete enabled text field, checkbox, etc.

  • There are 3 standard buttons which always have the same function "add" adds an item of the same kind, "delete" removes the present item, and "delete" clones the present item with all its data. Use the cloning mechanism if you intend to enter more complex structures repeatedly, such as for establishment organizations or parts of a product kit.

  • Copy & Paste functions are implemented for certain data elements. For example, addresses can be copied and pasted between different organizations or persons. Also, products (drug and devices) can be copied and then pasted to be parts of kits. If available, a button [%] means copy to clipboard and [&] means paste from clipboard.

  • To load an existing file, press the "Load File" button, select the file and press the "Load File" button in the file browser.

  • Adding data elements is possible by using the various other buttons which are presented by a single upper-case letter in square brackets (e.g. [A], [B], etc.) To understand the function of the buttons, please hover over them with the mouse to see the tool tip. The letters are chosen to be mnemonic and unambiguous, not always the initial of the data element name (e.g., "drug" and "device" both start with "D" hence we use the next distinguishing consonant "dRug" "deVice" to distinguish the two buttons.)

  • To add an image into content of labeling, take the following steps:

    1. On the Section frame, click the "Image [+]" button.
    2. Click on [Choose Image] button, select a JPEG image and press the "Choose Image" button in the file browser. Please select an image having a size less than 1 MB, otherwise it will throw an error message above the Tabs.
    3. Finally add the image into the section text block using the "Insert/edit image" button that appears when the focus is on the Text block. You will be presented with a drop-down list of all images added in the previous steps. Pick one of those images, and without changing the Image URL field, click "Insert". Internet explorer will show only partial image if the image size is more than 32 KB.

  • For efficiency, always start with an existing SPL or template which most closely matches the new SPL you need to create. When creating an SPL from another SPL, be sure to delete the contents of identifier fields (e.g., document and section ids). Simply removing an old identifier will cause the system to automatically place a newly generated identifier in the empty field. When creating an SPL from a template, all identifiers are newly generated, hence there is no need for clearing identifiers when creating an SPL from a template.

  • For efficiency, use cloning and copy & paste as much as possible. If you need to enter multiple data element structures that are similar (e.g., multiple products that are minor variants of each other or different kit configurations), create one complete product data structure first and use that as a prototype to create the variants by using the clone button [#] or by copy [%] and then paste [&] into another structure. Be sure to have added all data elements for the prototype product and then simply modify them. For example, for 2 drug products with the same ingredients but different strengths create one product with all ingredients, clone it and only edit the strengths.


For help, click the "Help" tab. Refer to the FDA SPL XForms web page for troubleshooting help and other advisories. For any remaining unanswered questions email may be sent to spl@fda.hhs.gov and spl@pragmaticdata.com.


Copyright (c) 2017 Pragmatic Data LLC. All rights reserved.

Government Restricted Rights Legend:The Pragmatic XForms SPL product is restricted computer software under the provisions of FAR 52.227-14 with Alternate III under the contract HHSF223200950194P and FAR 52.227-19under the contract HHSF223201110180C, Pragmatic Data LLC grants to the FDA a perpetual, non-exclusive, and non-transferable license to use the product and to permit the public to use the product through websites operated by the FDA. Any other rights regarding the use, duplication, or disclosure of this computer software, according to FAR 52.227-14 Alternate III (d), shall be specified as follows:

The FDA may distribute the product to the public through a redistributable file delivered by Pragmatic Data to the FDA for this purpose. The license to redistribute this file shall be granted only to the FDA and is not transferable and not assignable to other parties. Pragmatic Data grants to the public receiving this file from the FDA a perpetual, non-exclusive, and non-transferable limited license to use the product at no charge. "Use" of the product shall mean to manually encode SPL content for data submissions to the FDA, but not to make the product available to others and not to embed it into larger works or web sites.

Under the restricted rights in data clause, Pragmatic Data reserves the right to modify the software and reserves all rights of redistribution of so modified software.

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