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As you review your documents, you will note that converted labels will likely not appear exactly the same as the source label from which they were converted. A number of differences are intentional and due to various restrictions or best practices that have been recommended by the FDA and the various SPL working groups. These intentional differences complicate document review and verification. This document was prepared by DCL to help you in your review process and to identify those differences that are intentional. Note: This guide is written using the SPL Schema, to provide information on the way that certain elements will be displayed by the stylesheet. This document itself has been parsed and validated against the SPL schema. This format was used so that the things described would be visible exactly as they would be displayed as rendered by the SPL stylesheet. If you have questions, Please contact DCL.

Section Headings Verbatim Text Boxes Text before the title Drug Product Listing Special Characters Logos and Stylized Characters Captions Reference Sections Submitting your SPL File Resources

The stylesheet provided by the FDA shows all headings in a standardized format -- regardless of how they were presented in your original documents. Best Practice is to follow this convention. The reason is to provide a level of uniformity among the labels as they get posted online on DailyMed and other sites providing this information. The following illustrates how the various section headings are rendered by the stylesheet. Regardless of appearance, the text in the section headings in the SPL will match the text in the section headings in the original document, including the casing of the words. Although section levels 1 through 9 are listed, Levels 7, 8, and 9 are rarely used.

The FDA stylesheet released in April 2006 no longer displays Verbatim text boxes, although the stylesheet is capable of displaying them. The following information is retained for reference only. Verbatim text boxes are gray text boxes generated as part of the rendering process by the stylesheet, but do not appear in the original document that was submitted for conversion. There are other gray boxes that appear in the document but are not verbatim text boxes. These are discussed in the section about Drug Product Listing.

The FDA stylesheet released in April 2006 no longer displays Verbatim text boxes, although the stylesheet is capable of displaying them. The following information is retained for reference only. Immediately after the title, but before any text, there is at least one (maybe more) gray box that says “<manufacturedProduct ... />”. This box is the verbatim display of the XML code in the Drug Product Listing section of the SPL. By clicking on this text, it will expand into the XML version of the Drug Product Listing. Clicking on various tags will expand the structure to allow you to view it.

The FDA stylesheet released in April 2006 no longer displays Verbatim text boxes, although the stylesheet is capable of displaying them. The following information is retained for reference only. At the bottom (end) of the rendering, there is another gray box. This box is the verbatim display of the entire SPL XML code. Similarly to the Drug Product Listing Verbatim Box, clicking on the tags in the box will expand them, allowing you to view the XML code that is behind the rendering of the SPL.

Some printed labels have information that appears before the document title. In the SPL schema, the title of the document, which is the title of the drug, is forced to always appear first. As a result, the first thing that renders is the title of the document. In cases where there is text that precedes the title, DCL takes this text and inserts it as the first section of the document, as an untitled section. This causes it to render immediately after the title.

The Drug Product Listing (provided to DCL as a spreadsheet) consists of the drug's name, strength, ingredients, characteristics, dosage forms, routes of administration, and all other relevant information, and is stored in the XML file as a machine-readable hierarchy of tags and text. The data is rendered by the stylesheet as a table at the end of the label. Sample Drug Product Listing data has been included in this document to demonstrate how it will render in an actual SPL. The data in the name fields is capitalized exactly as provided to DCL. The strength units, dosage forms, and package types, though, will be displayed using the display names that correspond to the codes outlined in the FDA Preferred Name and NCI Thesaurus Codes at http://www.fda.gov/oc/datacouncil/splncicodes.html. Each ingredient is rendered as a separate row in the table. The first column displays the name of the ingredient, and its active moiety, if applicable. The second column indicates if the ingredient is active or inactive. The third column indicates the strength, if applicable, as a ratio of one quantity in another.

This section displays a package description and shows the number of units in a package. The stylesheet indicates if a package is contained within another package.

The current stylesheet introduces enhancements for multiple component drugs. While previous releases of the stylesheet displayed information only for the overall product, the current release displays information for all parts. The stylesheet generates a table for each part in a multiple component product, using the same fields and layout as a single component product. In addition to the fields for a single component product, for a multiple component drug, the stylesheet displays the quantity of each part and a count of the total number of parts in the product.

Special characters are turned into either XML entities or Unicode characters, depending on the guidelines set forth in the SPL Implementation Guide. The character displayed will be the same as the character in the original document. The exception to this is when certain special characters (such as Greek letters) are used in certain <title> fields. Some title fields automatically uppercase all of the letters, and as a result, these special characters are uppercased as well. One example of this is the Greek letter μ (mu). When uppercased, it will appear as M (capital M). Certain special characters, such as the Registered Trademark(®), Trademark(™), and Copyright symbol(©) are often inserted into the Drug Product Listing (metadata). These characters are not to be used; as a result they will not appear in the rendering of the SPL Drug Product Listing. They may appear in other parts of the document though.

The FDA designed the SPL standard to focus only on content. For this reason, they prefer that company logos and stylized characters (such as those imprinted on a tablet that look different than normal characters) are not used. The preferred method of representing these logos and characters is to use the text itself (e.g. if the symbol is a stylized D, and the company logo is a graphical representation of "DrugCo," then these items would be represented in the SPL as a "D" and "DrugCo," respectively.

Regardless of where the caption appears in the original document, the stylesheet formats captions as follows: Figure captions are displayed below the image. Table captions are displayed above the table. Captions are always centered.

If the label has a section of works that have been cited as reference sources, then this section will appear at the end of the SPL, regardless of where it appears in the XML and the original document. This is due to the stylesheet interpreting the LOINC codes that are attached to the sections.

After reviewing the SPL and verifying that its content matches that of the original file, you would submit the SPL files to the FDA. DCL has provided you with all of the necessary files to review the SPL prior to submission, but please note that not all of these files need to be sent in to the FDA for approval. Please see Regulatory Submissions in Electronic Format - Content of Labeling for information on submitting SPL to FDA at http://www.fda.gov/cder/guidance/guidance.htm for this information. This information is also available in the SPL Implementation Guide, Section 6, which can be viewed at http://www.fda.gov/cder/regulatory/ersr/SPL2aIG_v20051006_r1.pdf. The implementation guide provides step-by-step instructions on which files must be submitted, the FDA's preference in file type, graphic resolution, naming convention, and other requirements.

The following are useful SPL resources:
Note: Since the SPL schema does not allow for external links, these links are not "clickable" Structured Product Labeling Resources - http://www.fda.gov/oc/datacouncil/spl.html DailyMed - http://dailymed.nlm.nih.gov/dailymed/about.cfm FDA Preferred Name and NCI Thesaurus Codes - http://www.fda.gov/oc/datacouncil/splncicodes.html Guidance Documents from CDER - http://www.fda.gov/cder/guidance/guidance.htm SPL Implementation Guide (Version 2a/Revision 2, January 2006) - http://www.fda.gov/cder/regulatory/ersr/SPL2aIG_v20060103.pdf Data Conversion Laboratory, Inc. - http://www.dclab.com/ DCL SPL Conversion Team - dclspl@dclab.com

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