PLR

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 * Which products are affected under the Physician Labeling Requirement?**

Physician Labeling Rule affects the following products:

 * New NDAs, BLAs, and efficacy supplements (e.g., new indication, new dosage regimen, new route of administration).
 * Applications and efficacy supplements approved up to 5 years prior to final rule

Older products are on an implementation schedule as follows: (encouraged to conform) ||
 * **NDA, BLA, or efficacy supplement** || **Labeling must conform** ||
 * Submitted on or after 06/30/06 || At time of submission ||
 * Pending on 06/30/06 Approved on 06/30/05 – 06/30/06 || 06/30/09 (3 years) ||
 * Approved 06/30/04 – 06/29/05 || 06/30/10 (4 years) ||
 * Approved 06/30/03 – 06/29/04 || 06/30/11 (5 years) ||
 * Approved 06/30/02 – 06/29/03 || 06/30/12 (6 years) ||
 * Approved 06/30/01 – 06/29/02 || 06/30/13 (7 years) ||
 * Approved Pre-06/30/01 || Voluntary at any time

Should I submit patient package inserts (PPIs), medication guides (MedGuides), and patient information leaflets (PILs) in SPL?  If your package insert has a PPI, MedGuide, or PIL at the end, that information should be included in SPL. There are specific LOINC codes for the PPI and the MedGuide subsections of the Patient Counseling Information section. Each of the approved patient labeling documents should have a separate LOINC code.

Patient information that is not part of the approved labeling, such as patient information produced by third parties, should not be included in SPL. Questions regarding the inclusion of approved labeling for patients in SPL should be directed to ONDEIO@cder.fda.gov  or to the appropriate review division.

__ References __ : [|SPL Standard for Content of Labeling Technical Qs & As]

**What are the foreign language requirements?**

Currently, foreign language directions do not need to be submitted in SPL. __ References __ : [|SPL Standard for Content of Labeling Technical Qs & As]

When do I need to Cross-reference?
 When information about the same topic is contained in more than one section, the section with the greatest clinical relevance (i.e., containing the most important information relevant to prescribing) will typically include a succinct description and will cross-reference the related sections that contain additional detail. If the detailed information is appropriately divided into more than one section, those sections should cross-reference each other. In some cases, cross references are required (e.g., §201.57(c)(1), (c)(6)(iv) and (c)(15)(ii)).

__References: __ [|Labeling for Human Prescription Drug and Biological Products --- Implementing New Content and Format Requirements (draft) Jan 2006 Labeling See http://www.fda.gov/cder/regulatory/physLabel/default.htm for any updates to the guidance.] See http://www.fda.gov/OHRMS/DOCKETS/98fr/06-545.pdf  for the Final Rule: Requirements on the Content and Format of Labeling for Human Prescription Drug and Biological Products, January 24, 2006. Effective June 30, 2006

// In highlights….. // The preferred presentation of cross-references is the numerical identifier in parentheses following the summarized labeling information (e.g., (1.1)).
 * What format should cross-references be in? / What is the preferred presentation of cross-references? **

//<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">In Full Prescribing Information (FPI)….. // <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">The preferred presentation of cross-references is the section heading followed by the numerical identifier (e.g., //see Indications and Usage (1.1)//). Because cross-references are embedded in the text in the FPI, the use of italics to achieve emphasis is encouraged.

__<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __ [|Labeling for Human Prescription Drug and Biological Products --- Implementing New Content and Format Requirements (draft) Jan 2006 Labeling] <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">See <span style="color: blue; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">http://www.fda.gov/cder/regulatory/physLabel/default.htm <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">for any updates to the guidance. <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">See <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">http://www.fda.gov/OHRMS/DOCKETS/98fr/06-545.pdf <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> for the Final Rule: Requirements on the Content and Format of Labeling for Human Prescription Drug and Biological Products, <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">January 24, 2006. Effective June 30, 2006

<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> Yes. Hypertext links can be retained within the SPL document. However, these links should be restricted to //semantic// links that are strictly identified within the content of labeling (e.g., 93//see// CLINICAL PHARMACOLOGY,94 or 93//see// references/footnotes94). Because links to documents outside of the SPL document may change without a change in the content of labeling, they should not be used.
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Can I retain within-document hypertext links if they were present in a Word or PDF file of content labeling (e.g., clickable cross-references)? **

__ References __ <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">: [|SPL Standard for Content of Labeling Technical Qs & As]

<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">**What if I have multiple //‘Initial//** **//U.S.//** **//Approval’// (§201.57(a)(3)) dates?**

Multiple dates should not be listed for products with multiple formulations approved or licenses in different years. For these products, //__list the initial approval date of the new molecular entity, new biologic product, or new combination of active ingredients__//.

__<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __ [|Labeling for Human Prescription Drug and Biological Products --- Implementing New Content and Format Requirements (draft) Jan 2006 Labeling] <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">See <span style="color: blue; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">http://www.fda.gov/cder/regulatory/physLabel/default.htm <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">for any updates to the guidance. <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">See <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">http://www.fda.gov/OHRMS/DOCKETS/98fr/06-545.pdf <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> for the Final Rule: Requirements on the Content and Format of Labeling for Human Prescription Drug and Biological Products, <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">January 24, 2006. Effective June 30, 2006

<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> FDA recommends the information in the BOXED WARNING be presented in //__a bulleted format__// with each bullet communicating a discrete warning or contraindication. In rare instances, the BOXED WARNING in the FPI may be sufficiently concise to warrant repeating the statement verbatim in the Boxed Warning in Highlights.
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">What format should the information within a boxed warning be in? **

__<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __ [|Labeling for Human Prescription Drug and Biological Products --- Implementing New Content and Format Requirements (draft) Jan 2006 Labeling] <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">See <span style="color: blue; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">http://www.fda.gov/cder/regulatory/physLabel/default.htm <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">for any updates to the guidance. <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">See <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">http://www.fda.gov/OHRMS/DOCKETS/98fr/06-545.pdf <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> for the Final Rule: Requirements on the Content and Format of Labeling for Human Prescription Drug and Biological Products, <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">January 24, 2006. Effective June 30, 2006

<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">No. There should only be one element in SPL. However, the schema permits tags within the element for multi-line titles. __ References __ <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">: [|SPL Standard for Content of Labeling Technical Qs & As]
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Can there be than one title in the header? (e.g., //Example Tablets, 10mg,// and //Example, Suspension, 1mg/mL//)? **

<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> No. The identifier of a section that is relocated without content change remains unchanged, but the identifiers of any enclosing sections before and/or after the relocation should be changed, as should the document identifier.
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">If a section or subsection is relocated without change to its content, should its section identifier be changed? **

__ References __ <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">: [|SPL Standard for Content of Labeling Technical Qs & As]

<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> Yes. A section can contain only subsections and no text. For example, Precautions General: The use of this drug may promote. . . Skeletal Muscle: In Phase 3 complicated skin and skin structure infections. ..
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Can SPL have a section that contains other sections but does not contain any other text? **

__References__: [|SPL Standard for Content of Labeling Technical Qs & As]

<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> Table titles, notes and information must be associated with the table at all times. This associated information is expected by the FDA, failure to do so may result in non-compliance of your submission.
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Do I always have to associate Table Titles, Notes and Table information to the Table? **

__<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __ [|SPL Implementation Guide Release 4/July 2008] <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">See <span style="font-family: Arial,Helvetica,sans-serif; font-size: 8pt;"> http://www.fda.gov/oc/datacouncil/spl.html <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">for any updates to the Implementation Guide

<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> The 'FDA SPL Implementation Guide for FDA Content of Labeling Submissions' recommends that all images be in the *.jpg format or *.gif format. In A4L, Images are automatically converted into *.jpg when exported.
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">What format should my images be in? **

__<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __ [|SPL Implementation Guide Release 4/July 2008] <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">See <span style="font-family: Arial,Helvetica,sans-serif; font-size: 8pt;"> http://www.fda.gov/oc/datacouncil/spl.html <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">for any updates to the Implementation Guide.


 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">What size and resolution should my images be in? **

<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">The SPL schema does not allow for resizing graphics or changing the resolution of graphic files. <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Thus, all images are rendered in the browser as-is, with all characteristics of the actual graphic file itself. To ensure that a graphic will appear as desired, the graphic file should be edited to a dimension appropriate for its presentation within the browser. //__The recommended resolution is 300 dpi. Images greater than 300 dpi should not be submitted to keep the file size manageable.__//

__<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __ [|SPL Implementation Guide Release 4/July 2008] <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">See <span style="font-family: Arial,Helvetica,sans-serif; font-size: 8pt;"> http://www.fda.gov/oc/datacouncil/spl.html <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">for any updates to the Implementation Guide.

<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> Attributes for table elements are currently not supported by the standard stylesheet and thus only minimal formatting will be seen by the FDA when they view your label. It is stated that “ <span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">SPL is used to communicate labeling content rather than the exact representation of drug information present in a typeset document. The table presentation in SPL is unlikely to exactly duplicate the presentation in word processed or typeset versions of the package insert”.
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">My tables don’t look proper. Can I format my table (i.e., cell spacing etc) to reflect the way I want it to look? **

__<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __ [|SPL Implementation Guide Release 4/July 2008] <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">See <span style="font-family: Arial,Helvetica,sans-serif; font-size: 8pt;"> http://www.fda.gov/oc/datacouncil/spl.html <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">for any updates to the Implementation Guide.

Can I rename Section Headings (ie. ‘Indications and Usage’) to something else? **
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">

<span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">The default SPL template complies with the section headers specified in §201.56 (d)(1) and §201.56(e)(1). Renaming these section headers may result in non-compliance of your submission.

<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">__ References __ <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">: Final Rule: Requirements on the Content and Format of Labeling for Human Prescription Drug and Biological Products, January 24, 2006. Effective June 30, 2006 <span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">http://www.fda.gov/OHRMS/DOCKETS/98fr/06-545.pdf <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Code of Federal Regulations <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

<span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> The default SPL template complies with the section headers specified in §201.56 (d)(1) and §201.56(e)(1). <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Rearranging these sections may result in your document no longer complying. __However, especially in the case of legacy labels, these may be accepted by the FDA.__
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Can I Rearrange Document Sections? **

__ References __ <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">: Final Rule: Requirements on the Content and Format of Labeling for Human Prescription Drug and Biological Products, January 24, 2006. Effective June 30, 2006 <span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">http://www.fda.gov/OHRMS/DOCKETS/98fr/06-545.pdf <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Code of Federal Regulations <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

<span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> Any required section, subsection, or specific information that is clearly inapplicable must be omitted from Highlights and the FPI. For example, if a drug is indicated for use only in males, and there are no preclinical data or clinical data relevant to women of childbearing potential, the //‘Pregnancy, Labor and Delivery and Nursing Mothers//’ subsections would be omitted because they are not applicable. <span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> When a section or subsection is omitted from the FPI, the section must also be omitted from the Contents (§201.56(d)(4)). The heading <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> //‘Full Prescribing Information:Contents´// must be followed by an asterisk and the following statement must appear at the end of the Contents: “*Sections or subsections omitted from the Full Prescribing Information are not listed” (§201.56(d)(4). <span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> In the example of a drug indicated for use only in males, the Contents heading appears as follows: <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">** FULL PRESCRIBING INFORMATION: CONTENTS* ** <span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">The numbering in the Contents and FPI appears as follows: <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">** 8 USE IN SPECIFIC POPULATIONS ** <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">8.4 Pediatric Use 8.5 Geriatric Use
 * <span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Can I delete sections, subsections? **

<span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">At the end of the Contents, the following statement appears:
 * 9 DRUG ABUSE AND DEPENDENCE **
 * <span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">*Sections or subsections omitted from the Full Prescribing Information are not listed. **

__<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __ [|Labeling for Human Prescription Drug and Biological Products --- Implementing New Content and Format Requirements (draft) Jan 2006 Labeling] <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">See http://www.fda.gov/cder/regulatory/physLabel/default.htm <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">for any updates to the guidance.

<span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> A major reason behind the implementation of SPL documents is to separate formatting from content. However, minimal formatting such as **bold**, //italics// and __underline__ can be used and is accepted. In addition, the following combinations of these attributes are also allowed: · **// bold-italics //** · //__italics__-underline// · **__bold-underline__** · **//__bold-italics-underline__//**.
 * <span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Can my document contain formatted (ie. bold, underline and italicized) text? **

__<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __ [|SPL Implementation Guide Release 4/July 2008] <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">See <span style="font-family: Arial,Helvetica,sans-serif; font-size: 8pt;"> http://www.fda.gov/oc/datacouncil/spl.html <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">for any updates to the Implementation Guide.

Can I add symbols or special characters? / What kind of symbols or special characters can I add? <span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> Certain symbols and special characters can be included in the text content or the header of the document. The following symbols and special characters are accepted by the FDA:


 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">mg/m2 (superscript)
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">C12H12O6 (subscript)
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">©
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">◦ (degree)
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">≤, <, ±
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">- (m-dash)
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Β (e.g., β-isomer)
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">® (e.g., Registered 1996)
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">™ (Trademark)
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">&
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">†, ‡
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">§
 * <span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">‘ (apostrophe)

__<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __ [|SPL Implementation Guide Release 4/July 2008] <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">See <span style="font-family: Arial,Helvetica,sans-serif; font-size: 8pt;"> http://www.fda.gov/oc/datacouncil/spl.html <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">for any updates to the Implementation Guide.

<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> No. Corporate or product logos, or similar graphics, are not considered part of the content of labeling and therefore should not be included in SPL. Trademark symbols can be included using standard text and //unicode// characters. Controlled substance symbols can be provided as text (eg. CII).
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Can I use specific graphics (eg. Registered trademark symbols, controlled substance symbols, corporate or product logos)? **

__<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __[|SPL Standard for Content of Labeling Technical Qs & As]

<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">No. The document LOINC code for SPL will identify SPL as human prescription drug labeling.
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Can I use a graphic for the Rx symbol? **

__<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __[|SPL Standard for Content of Labeling Technical Qs & As]

What is the numbering format for footnotes?

> <span style="color: black; font-family: Arial,Helvetica,sans-serif;">Footnotes within tables are rendered at the bottom of the table. __<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __ [|SPL Implementation Guide Release 4/July 2008] <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">See <span style="font-family: Arial,Helvetica,sans-serif; font-size: 8pt;"> http://www.fda.gov/oc/datacouncil/spl.html <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">for any updates to the Implementation Guide.
 * Footnotes are rendered using Arabic numbers (i.e., 1,2,3,4 etc.) within the text body of the document.
 * <span style="font-family: Arial,Helvetica,sans-serif;">Within tables, footnotes are rendered using footnote marks in the series * # † ‡ § ¶ ♠ ♥ ♦ ♣

<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">The 'FDA SPL Implementation Guide for FDA Content of Labeling Submissions' specifies a standard set of specialized markers for numbered and bulleted lists. <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> Ordered lists can be listed in any of the following ways: <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> Unordered lists can be listed in any of the following ways: · Disc (List bullets are simple solid discs: ●) · Circle (List bullets are hollow discs: ○ ) · Square (List bullets are solid squares: ■ )
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Is there a specific numbering style or bullet type for lists? **
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Arabic (1, 2, 3 …)
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Little Roman (i, ii. iii …)
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Big Roman (I, II, III…)
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Little Alpha (a,b,c…)
 * <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">BigAlpha (A,B,C….)

__<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __ [|SPL Implementation Guide Release 4/July 2008] <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">See <span style="font-family: Arial,Helvetica,sans-serif; font-size: 8pt;"> http://www.fda.gov/oc/datacouncil/spl.html <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">for any updates to the Implementation Guide.

<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">** Can the proprietary and established (or proper) names be presented on the same line in Highlights? ** <span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">

To conserve space in Highlights, the proprietary and established names should be presented on the same line, unless they are too long. In that case, the established name should be presented on the line underneath the proprietary name.

__<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __ [|Labeling for Human Prescription Drug and Biological Products --- Implementing New Content and Format Requirements (draft) Jan 2006 Labeling] <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">See <span style="color: blue; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">http://www.fda.gov/cder/regulatory/physLabel/default.htm <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">for any updates to the guidance.


 * <span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Is there a preferred format for the revision date?/What format should the revision date be in? **

<span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">The date of the most recent revision must be presented at the end of Highlights in accordance with §201.57(a)(15). The preferred format is “Revised: Month (yyyy) or Revised: 0m/yyyy” (i.e., Revised: June 2003 or Revised: 06/2003)

__<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __ <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">Labeling for Human Prescription Drug and Biological Products --- Implementing New Content and Format Requirements //(draft)// Jan 2006 Labeling <span style="color: blue; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">http://www.fda.gov/cder/guidance/6005dft.pdf <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">See <span style="color: blue; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">http://www.fda.gov/cder/regulatory/physLabel/default.htm <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">for any updates to the guidance.

<span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> FDA recommends that Latin abbreviations be avoided because of the greater potential for medication errors should an abbreviation be misread.
 * <span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Should Latin abbreviations be used in the ‘Dosage and Adminsitration’ section (e.g., //qd// versus //once daily?//) **

__<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __ [|Labeling for Human Prescription Drug and Biological Products --- Implementing New Content and Format Requirements (draft) Jan 2006 Labeling]<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;"> See <span style="color: blue; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">http://www.fda.gov/cder/regulatory/physLabel/default.htm <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">for any updates to the guidance.

<span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> FDA recommends that each contraindication be identified by its own subheading.
 * <span style="color: black; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">How should the ‘Contraindications’ section be formatted? **

__<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 120%;">References: __ [|Labeling for Human Prescription Drug and Biological Products --- Implementing New Content and Format Requirements (draft) Jan 2006 Labeling]<span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;"> See <span style="color: blue; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">http://www.fda.gov/cder/regulatory/physLabel/default.htm <span style="color: red; font-family: Arial,Helvetica,sans-serif; font-size: 8pt;">for any updates to the guidance.

<span style="font-family: Arial,Helvetica,sans-serif;">Links
<span style="font-family: Arial,Helvetica,sans-serif;">Physicians Labeling Rule: http://www.fda.gov/cder/regulatory/physLabel/default.htm