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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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SOPP 8412: Review of Product Labeling

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Version #4 

Effective Date: April 2, 2012


 

  1. Purpose

    This SOPP outlines the general operating procedures for Center for Biologics Evaluation and Research (CBER) staff to process draft and final product labeling submissions.

     
  2. Scope

    This SOPP applies to the review of product labeling for Biologics License Applications (BLA), New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), their respective supplements, and annual reports.

     
  3. Background

    1. Proper labeling of licensed and approved products is a requirement of the Food, Drug and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act). Labeling is reviewed as part of a BLA, NDA, ANDA, their respective supplements, annual reports or product correspondence (First Use notification only) when appropriate to ensure the information is correct and that the product is not misbranded.
       
    2. The mechanism for reporting changes to labeling varies according to the type of change and the change's potential for having an adverse effect on product identity, strength, quality, purity, or potency as described in 21 CFR 601.12 and 314.70. The reporting categories allowed by these regulations include several different administrative processes for labeling submission and review. For drugs and biologics subject to 21 CFR 314.70 and 601.12, respectively, changes to a product package label, container label, and package insert require either: (1) submission of a supplement with FDA approval needed prior to product distribution (Prior Approval Supplement (PAS)); (2) submission of a supplement with Changes Being Effected (CBE); or (3) submission of the final printed labeling in an annual report.
       
    3. On December 11, 2003, FDA published a Final Rule (68 FR 69009 - the Electronic Labeling Rule (ELR)), requiring the submission of content of labeling in electronic format for marketing applications beginning June 8, 2004. The requirements of the rule can be found in 21 CFR 314.50(l)(1)(i) for NDAs, 314.94(d)(1)(ii) for ANDAs, 601.14(b) for BLAs and 314.81 (b)(2)(iii)(6) for annual reports. Following publication of the Final Rule, FDA issued Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Content of Labeling in April 2005. The publication of this guidance indicated that the electronic format by which content of labeling should be submitted is Structured Product Labeling (SPL), which utilizes Extensible Markup Language (XML).
       
    4. In the Federal Register of February 26, 2004 (69 FD 9120), the FDA published a Final Rule requiring certain human drug and biological products to have on their labels a linear bar code that contains, at a minimum, the drug’s NDC number (21 CFR 201.25).
      1. Bar Code requirements:
        1. Drugs approved on or after April 26, 2004, have 60 days from their approval date to comply with the bar code requirement (21 CFR 201.25)
        2. All other drugs subject to the bar code requirement, including drugs with applications approved before April 26, 2004, must implement the requirements within 2 years of the effective date (i.e., no later than April 26, 2006) (21 CFR 201.25)
        3. A drug manufactured on or after April 26, 2006, must bear a bar code. A drug manufactured and distributed by the manufacturer before April 26, 2006, will not need to be recalled or repacked to bear a bar code.
        4. The rule requires machine-readable information on blood and blood component labels (21 CFR 606.121 (c) (13)).
        5. The rule applies to drug manufacturers, repackers, relabelers, and private label distributors who are subject to the establishment registration requirements under the Act
        6. Refer to Guidance for Industry: Bar Code Label Requirements Questions and Answers (August 2011) for additional information. This document also covers the requirements for machine-readable label requirements for blood and blood components.
           
    5. In January 2006, FDA issued a Final Rule (71 FR 3922 - the Physician Labeling Rule (PLR)), which required labeling for BLAs and NDAs to conform to 21 CFR 201.56 and 201.57 beginning June 30, 2006. For BLAs, NDAs, and efficacy supplements approved prior to June 2001, implementation of the PLR is voluntary. The PLR revised the existing labeling regulations to require that the prescribing information of new and recently approved products include a cross-referenced Highlights section and Table of Contents along with the Full Prescribing Information. It also established certain required content, the reordering of the label, and minimum format requirements. The intent of the PLR was to make the prescribing information more accessible and informative for practitioners to improve risk and benefit communications as well as risk management.
       
    6. In July 2006, the Institute of Medicine (IOM) published a report entitled Preventing Medication Errors which cited labeling and packaging issues as the cause of 33 percent of medication errors, including 30 percent of fatalities from medication errors. Given the critical role of the label and labeling in the safe use of drug products, we rely on four major labeling reviews to ensure accurate information is provided in a manner understandable to physicians and patients. These include Proper (Established) Name Review, Proprietary (Trade) Name Review, Content of Labeling Review, and Container/Carton Label Review.
       
    7. On September 27, 2007, the Food and Drug Administration Amendments Act (H.R. 3580 FDAAA) was established. In conjunction with the reauthorization of the Prescription Drug User Fee Amendments of 2007 (PDUFA IV), the FDA agreed to meet specific performance goals. These performance goals are described in PDUFA Reauthorization Performance Goals and Procedures. For these performance goals, CBER agreed to develop review procedures and timelines for its staff (i.e. how to notify applicants of planned review timelines for original NDA/BLA applications and efficacy supplements). Although non-PDUFA products are not subject to PDUFA goals, CBER strives to meet these review timelines for non-PDUFA products, as resources allow.
       
    8. A Circular of Information for the Use of Human Blood and Blood Components (the “Circular”) has been developed by the major industry organizations representing blood establishments and is reviewed by FDA to ensure compliance with 21 CFR 606.122. CBER announces in guidance that a particular version of the "Circular" is an acceptable standard and that it complies with the requirements and thereafter a copy of the Circular does not have to be submitted or reviewed with each submission if the accepted version is in use. After CBER’s announcement of acceptance of a Circular in a guidance document, firms may report the use of the accepted Circular in their annual reports if there are no changes made to the accepted version of the Circular.
       
  4. Definitions
     
    1. Label - Display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any product or affixed to or appearing upon a package containing any product. (21 CFR 1.3(b)).
       
    2. Labeling - All written, printed, or graphic matter accompanying an article at any time while the article is in interstate commerce or held for sale after shipment or delivery in interstate commerce (21 CFR 1.3(a)). Labeling includes the container labels, package insert (or professional labeling), the patient package insert, medication guides, instructions for use, risk management materials and promotional labeling.
       
    3. Content of labeling - All text, tables, and figures, such as contents of the package insert or professional labeling, patient package insert, and medication guide required under 21 CFR 201.100(d)(3). The Physicians Labeling Rule (PLR) specifies a format for the content of labeling.
       
    4. First Use Notification:
      1. Final Printed Labeling - Version (paper or SPL) of label or labeling (carton and container and accompanying matter) available immediately upon marketing of the product and submitted to CBER as product correspondence or in an annual report.
      2. Final Content of Labeling - All text, tables, and figures, such as contents of the package insert or professional labeling, patient package insert, and medication guide required under 21 CFR 201.100(d)(3) submitted in electronic format (Final SPL) and submitted to CBER as product correspondence. 21 CFR 601.14.
         
    5. Structured Product Labeling (SPL) - The electronic format by which content of labeling should be submitted. SPL utilizes Extensible Markup Language (XML).
       
  5. Policy
     
    1. SPL formatted content of labeling (.XML file) and a Microsoft (MS) Word-formatted version (.doc file) should be submitted with original BLA/NDA/ANDA submissions, efficacy supplements, and all supplements that require review of labeling. An MS Word version is not required for changes reported in an annual report.
       
      • Labeling negotiations for original and supplemental BLA/NDA/ANDA submissions are performed using the track changes (redline/strikeout) function in MS Word. Note: there may be instances that require explanatory text or separate annotation within the document or as a separate document.
      • A revised SPL is not required during the labeling negotiations.
      • SPL can accommodate both PLR and non-PLR formats, Medication Guides, Patient Package Inserts (PPIs) and Instructions for Use. 

        Note: This step does not apply to human blood and blood component products using an Instruction Circular or labeling associated with licensed in vitro diagnostic (IVD) products.
         
    2. Labeling revisions are subject to the provisions under FDAAA Section 901 for Safety Labeling Changes and FDAAA Section 501 for the Pediatric Research Equity Act (PREA).
       
    3. For approved products, changes to product labeling will be considered a supplement to the applicant's BLA/NDA/ANDA unless the change qualifies as reportable in an annual report (21 CFR 314.70 and 601.12).
       
    4. Labeling submitted to annual reports are only those types of changes outlined in 21 CFR 314.70(d) or 21 CFR 601.12(f)(3). These are usually minor/editorial-type labeling changes. Annual reports will be handled in accordance with SOPP 8411.1: Administrative Handling and Review of Annual Reports for Approved Biologics License Applications (BLAs).
       
    5. For human blood and blood component products, a revised instruction Circular should be submitted in the following situations:
      1. A firm may modify the “Circular” to contain facility specific information or to include additional products or cautions announced by the FDA. Depending on the type of information added, the submission of a modified Circular of Information may be a PAS, CBE or annual report.
      2. When a firm submits a supplement for a new product and provides an instruction circular or indicates that the “Circular” has been modified, the submission is categorized as a PAS. CBER review of the circular is to ensure the content is in compliance with the regulations or that the modified “Circular” is consistent with the accepted standard Circular of Information. Any modifications requiring additional review are identified. See Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components.
         
    6. At the time of First Use (at time of distribution or sale), the applicant must submit the following as product correspondence or in an annual report if its submission coincides with distribution:
      1. Final content of labeling (21 CFR 601.14) in SPL format.
      2. Final advertisement and promotional labeling at the time of initial dissemination or publication, on Form FDA 2253 (21 CFR 601.12(f)(4)).
      3. Three original paper copies of the revised carton and container final printed labeling (21 CFR 601.12(f)). In addition, the applicant may submit images (.jpeg) of all revised cartons and containers in the SPL.
         
    7. For multiple supplements that include labeling revisions under review for the same product/same applicant, a coordinated review of all submitted label changes should be conducted to ensure coordination with all open submissions and include language of recently approved versions.
      1. Upon receipt of approved language from a CBER review team, the newly approved language will be reviewed by other affected review teams to determine whether or not that language will impact their review.
      2. Labeling coordination should be performed by an RPM or other assigned person who is designated as the labeling coordinator. The labeling coordinator should be invited to all labeling meetings and should be included in all written labeling communications with the applicant. The labeling coordinator will determine if his/her attendance is necessary for specific meetings.
         
    8. Pending CBE safety language should not be included in another pending labeling supplement until after CBE approval. The RPM or labeling coordinator should make review teams for the same product/same applicant aware of pending safety information under review. The purpose of notification is to make review teams aware of pending safety information for consideration in their review.
       
    9. Labeling revision requests to the applicant should be as complete as possible. The applicant is responsible for revising and resubmitting proposed labeling for review if labeling revisions are necessary.

      Note: An SPL file may include changes approved in more than one submission. Any approval to revised content of labeling must be reflected in all other open submissions (i.e., applicants of open labeling supplements should be asked to update the proposed labeling in an amendment). Thus, at any given time, the SPL that is approved (and posted publicly) reflects the most inclusive and up-to-date content of labeling. Refer to Regulatory Job Aid JA 900.02: SPL Content of Labeling for additional information.
       
    10. Under the PDUFA IV goals, the Agency agreed to notify the applicant of an original NDA/BLA application or efficacy supplement of the planned target date for communication of proposed labeling.
       
  6. Responsibilities
     
    1. Review Team
      1. Participates in the labeling review.
      2. Provides comments as appropriate in review memorandum.
         
    2. Regulatory Project Manager (RPM)
      1. Ensures compliance with formatting requirements (21 CFR 201.56 and 201.57).
      2. Facilitates, as necessary, the coordination of label and labeling review activities, such as ensuring assignment of appropriate discipline team members, scheduling labeling meetings, communication with the applicant, etc.
      3. Serves as the primary point-of-contact with the applicant. The RPM should be included in all communications with the applicant.
         
    3. Clinical Reviewer
      1. Ensures accuracy of clinically relevant product information in the labeling and compliance with content requirements i.e. Pediatric Research Equity Act (PREA), PLR, and all labeling regulations (see comprehensive list in the references section).
      2. For human blood and blood components, the clinical reviewer ensures the Circular of Information is compliant with 21 CFR 606.122 and label contents are consistent with 21 CFR 606.121 and 640.70.
      3. Evaluates the Advertising and Promotional Labeling Branch (APLB) recommendation for Proprietary Name Review (PNR). Includes evaluation supporting or disagreeing with APLB recommendation for the proprietary name in the clinical review memo.
         
    4. Statistician

      Analyzes clinical data in submission and ensures accuracy of statistical clinical data relative to the information provided in the labeling.
       
    5. Clinical Pharmacology Reviewer

      Ensures accuracy of mechanism of action statements, pharmacodynamics, pharmacokinetics, and information on the impact of age, gender, and race in the labeling
       
    6. Non-Clinical Toxicologist Reviewer

      Ensures accuracy of non-clinical toxicology product information relative to information provided in the labeling
       
    7. Chemistry Manufacturing and Control (CMC) Reviewer
      1. Ensures accuracy of chemistry and manufacturing product information relative to the information provided in the labeling. (Storage conditions, suitable expiry periods established, etc.)
      2. Reviews UNII (Unique Ingredient Identifier) Code request, in collaboration with FDA’s Substance Registration System (SRS), and concurs with the recommendation as appropriate. See Regulatory Job Aid JA 900.01: UNII Code for additional information.
         
    8. Advertising and Promotional Labeling Branch (APLB) Reviewer
      1. Performs Proprietary Name Review (PNR); confers with the clinical reviewer and/or chair as needed.
      2. Consults on the content of labeling from a labeling comprehension and promotional perspective to ensure that it is not false or misleading to the target audience(s) (i.e., healthcare providers, patients, special populations).
      3. Reviews labels and labeling to reduce possible medication errors and evaluates promotional claims.
         
    9. Labeling Coordinator (if assigned)
      1. Coordinates labeling issues during a review.
      2. Coordinates review of multiple pending supplements that include labeling revisions to ensure approved labeling includes all recently approved labeling revisions, as applicable.
      3. Ensures all bar code information submitted by an applicant is reviewed. See Appendix A for 2D bar codes when applicable.
      4. Ensures National Drug Code (NDC) assignment(s) is accurate. See Regulatory Job Aid JA 900.08: National Drug Code and Bar Code Labeling Review for additional information
         
  7. Procedures

    Not all process steps outlined below apply to labeling reviews associated with human blood and blood component products or licensed in Vitro Diagnostic (IVD) products. Refer to the following regulatory job aids for additional information:

    JA 910.04: Labeling Review of Licensed in Vitro Diagnostic Products
    JA 910.05: Labeling Review for Whole Blood and Blood Components including Source Plasma and Source Leukocytes

    Reviewer tools are available on the following FDA Intranet Websites: CDER Study Endpoint and Labeling Development (SEALD) Website and SPL Resource page on the Data Standards Council Website.

    Additional submissions with labeling may be obtained using Regulatory Job Aid JA 910.03: RMS/BLA Database Search for Labeling Submissions, as applicable.
     
    1. Original BLA/NDA/ANDA
      1. Initial processing:
        1. Verify labeling (i.e. content of labeling, carton, and container labels) has been submitted including an SPL (.XML) file and a MS Word (.doc) version, if applicable. [RPM]
        2. Request reviewer assignments for clinical, statistics, clinical pharmacology, toxicology, CMC, and APLB, and others as applicable. [RPM]

          Note: A clinical reviewer is included for all content of labeling revisions.
      2. Examine all labeling components and note any missing information at the Filing Meeting. [Review Team]
      3. Determine the planned target date for communication or feedback regarding labeling to the applicant for inclusion in the Filing Letter. [Review Team]
      4. For Proper (Established) name review, ensure compliance with naming conventions as established by US Adopted Name Council (USAN) or office-specific policies if no USAN name is available. [Chair]
      5. Confirm submission of the Proprietary Name Review (PNR) request in the application and record the proposed proprietary name in the appropriate regulatory database, per Regulatory Job Aid JA 910.02: Proprietary Name Review (PNR) Processing. [RPM]
      6. Review proprietary name to ensure compliance with the regulations according to SOPP 8001.4: Review of CBER Regulated Product Prioprietary Names. [APLB Reviewer]
        1. Determine if the PNR request is complete. If incomplete, prepare letter-ready comments to be conveyed to applicant. [APLB Reviewer, RPM]
        2. Document recommendation in a review memorandum. Refer to Regulatory Job Aid JA 910.02: Proprietary Name Review (PNR) Processing for additional information. [APLB Reviewer]
        3. Evaluate the APLB recommendation (memo) and include whether the proposed proprietary name was acceptable or not acceptable in the clinical review memo or in the SBRA. [Clinical Reviewer, Chair]
      7. Communicate to the applicant the result, tentative acceptance or non-acceptance, of the PNR within the regulatory time frame (90 days of the receipt of the complete PNR submission). Document communication in the appropriate database. [RPM]
      8. Ensure UNII Code request is submitted to CBER SRS; concurs with the SRS recommendation, as appropriate. Refer to regulatory job aid JA 900.01: UNII Code for additional information [CMC reviewer]
      9. Ensure compliance with labeling requirements as described in 21 CFR Parts 201, 202, 606, 610, and 640 as applicable. [Review Team]
      10. Review labeling from a promotional and comprehension perspective, including consideration of potential medication errors due to content and format issues. [APLB Reviewer]
      11. Ensure compliance with promotional labeling and advertising requirements as described in 21 CFR Part 202, Prescription Drug Advertising. [APLB Reviewer]
      12. Ensure accuracy of NDC and bar code information. [Labeling Coordinator]
      13. Hold labeling meeting(s) from approximately mid-cycle timeframe to discuss proposed labeling revisions. [Review Team]
        1. Complete a thorough review of the labeling before the labeling meeting. [Review Team]
        2. Collaboratively identify labeling requirements/revisions. [Review Team]
        3. Summarize labeling issues identified at this meeting for inclusion in the Summary Basis of Regulatory Action (SBRA), as appropriate [Committee Chair, RPM]
        4. Prepare a formal review memorandum with labeling revision recommendations based on labeling discussions, as appropriate. [APLB reviewer]
          • Additional consults with APLB are available on a case-by-case basis thereafter, but output that results from these further consultations may not be provided in an additional formal memorandum. These additional comments may be conveyed via meeting minutes, telecon minutes, or email communications.
      14. Communicate labeling revision to the applicant. Communications may include any revision requests previously communicated but not already addressed (i.e. Filing Letter, etc.). [RPM; Labeling Coordinator]
        1. This communication may occur anytime during the review, however, it most commonly occurs after the labeling meeting.
        2. If needed, labeling meeting(s) may be held with the applicant to resolve labeling disagreements or provide clarification. [Review Team]
      15. Upon receipt of draft labeling revised as a result of labeling negotiations, confirm changes are consistent with requested changes. [RPM; Labeling Coordinator]
      16. Process revised draft labeling submitted as an amendment to the pending application and, if revised labeling is submitted outside the normal DCC procedures (i.e. email to RPM), assign a third level STN. [RPM]
        1. Note: if the amendment is submitted as part of an eCTD submission, the applicant must submit the amendment through the Agency’s Electronic Submission Gateway (ESG)
        2. Please refer to CBER’s Internet Electronic Submissions Web page for additional information (see references)
      17. Document in the review memorandum any labeling issues that should be identified in the SBRA. [Review Team]
      18. Perform re-evaluation of PNR within 90 days of action due date and document outcome in a review memorandum. [APLB]
      19. Communicate results of re-evaluation of PNR to applicant within 90 days of action due date. [RPM]
      20. Notify applicant of final draft labeling approval using the most recent approved letter template located on CBER’s Review Letter Templates Intranet Webpage. The approved labeling is either appended to or otherwise identified in the approval letter. [RPM]

    2. Labeling Changes Submitted After Approval of original BLA/NDA/ANDA (21 CFR 314.70 and 601.12)

      Process annual reports per SOPP 8411.1: Administrative Handling and Review of Annual Reports for Approved Biologics License Applications (BLAs).
      1. Determine if the proposed labeling change is classified under the correct change category (PAS, CBE, annual report). [Review Team]
        1. Promptly notify the applicant by telephone and letter, if the category is incorrect, and inform them of the correct category. [RPM]
        2. Request reviewer assignments, as applicable, for clinical, statistics, clinical pharmacology, toxicology, CMC, and APLB. [RPM]

          Note: A clinical reviewer is included for all content of labeling revisions.
        3. Provide submission link to the review team along with a list of associated submissions that have open labeling for review [RPM]
      2. Ensure the submission includes an SPL that reflects currently approved labeling in addition to the requested change for that submission. [RPM; Labeling Coordinator]

        Note: Pending CBE safety language should not be included in another pending labeling supplement until after CBE approval. The RPM or labeling coordinator should make review teams for the same product/same applicant aware of pending safety information under review. The purpose of notification is to make review teams aware of pending safety information for consideration in their review.
      3. Perform a comparison to the previous version of changes to approved labeling received in SPL format and document any differences. Refer to Regulatory Job Aid JA 900.09: SPL Comparison Instructions for additional information. [RPM]
      4. Examine all labeling components and note any missing information at the Filing Meeting [Review Team]
      5. Determine the planned target date for communication or feedback regarding labeling to the applicant for inclusion in the Filing Letter. [Review Team]
      6. Ensure UNII Code is correct or, if applicable, request is submitted to CBER SRS; concurs with the SRS recommendation, as appropriate. Refer to regulatory job aid JA 900.01: UNII Code for additional information [CMC reviewer]
      7. Ensure compliance with labeling requirements as described in 21 CFR Parts 201, 202, 606, 610, and 640 as applicable. [Review Team]
      8. Review labeling from a promotional and comprehension perspective, including consideration of potential medication errors due to content and format issues. [APLB Revviewer] 
      9. Ensure compliance with promotional labeling and advertising requirements as described in 21 CFR Part 202, Prescription Drug Advertising. [APLB Reviewer]
      10. Ensure accuracy of NDC and bar code information. [Labeling Coordinator]
      11. Hold labeling meeting(s) from approximately mid-cycle timeframe to discuss proposed labeling revisions. [Review Team]
        1. Complete a thorough review of the labeling before the labeling meeting. [Review Team]
        2. Collaboratively identify labeling requirement/revisions. [Review Team]
        3. Summarize labeling issues identified at this meeting [Committee Chair, RPM, labeling coordinator]
        4. Prepare a formal review memorandum with labeling revision recommendations based on labeling discussions, as appropriate. [APLB reviewer]
          • APLB will perform formal reviews on a case-by-case basis for supplements. For minor labeling changes, APLB comments may be conveyed via meeting minutes, telecon minutes, or email communication.
      12. Communicate concerns raised during labeling comparison with applicant. [RPM; Labeling Coordinator]
      13. Communicate labeling revisions to the applicant. Communications may include any revision requests previously communicated but not already addressed (i.e. Filing Letter, etc.). [RPM; Labeling Coordinator]
        1. This communication may occur anytime during the review, however, it most commonly occurs after the labeling meeting.
        2. If needed, labeling meeting(s) may be held with the applicant to resolve labeling disagreements or provide clarification. [Review Team]
      14. Upon receipt of draft labeling revised as a result of labeling negotiations, confirm changes are consistent with requested changes. [RPM; Labeling Coordinator]
      15. Research concurrent open submissions with labeling for review to ensure coordination with all open submissions. [RPM; Labeling Coordinator]
      16. Notify the review team(s) of any pending supplements for the same product/applicant so that the newly approved version of the labeling can be requested from the applicant, if the applicant does not amend the submission to include the newly approved labeling. [RPM, Labeling Coordinator]
      17. Notify applicant of final draft labeling approval using the most recent approved letter template located on CBER’s Review Letter Templates Intranet Webpage. The approved labeling is either appended to or otherwise identified in the approval letter. [RPM]
         
  8. Appendix
     
    1. Bar Codes
       
  9. References
     
    1. References below are located on CBER’s Intranet Web Page (unless otherwise noted)
      1. CDER Study Endpoint and Labeling Development (SEALD) Website on FDA’s Intranet
      2. SPL Resource page on the Data Council Website on FDA’s Intranet
      3. Regulatory Job Aids:
        1. 900.01: UNII Code
        2. 900.02: SPL Content of Labeling
        3. 900.08: National Drug Code and Bar Code Labeling Review
        4. 900.09 SPL Comparison Instructions
        5. 910.02: Proprietary Name Review (PNR) Processing
        6. 910.03: RMS/BLA Database Search for Labeling Submissions
        7. 910.04: Labeling Review of Licensed in Vitro Diagnostic Products
        8. 910.05: Labeling Review for Whole Blood and Blood Components including Source Plasma and Source Leukocytes
           
    2. Web links to the references below can be found in the list following the History Table
      1. 21 CFR

        Parts §§201, §201.10( c), §201.56, §201.57, 201.80, §201.100(d)(3), §202.1, §299.4, §314.50(l)(1)(i), §314.70, §314.81 (b), §314.94(a)(8), §601.12, §601.14(b), §610, §606,122
      2. Electronic Submissions Web Page
      3. Food and Drug Administration Amendments Act (FDAAA), September 2007
      4. Prescription Drug User Fee Act (PDUFA)
      5. Guidance for Industry: An Acceptable Circular of Information for the Use of Human blood and Blood Components; December 2009
      6. Federal Register:
         
        Federal Register (FR) main page
        1. Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, (commonly referred to as the Physician Labeling Rule [PLR]), January 2006
        2. Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format (commonly referred to as the Electronic Labeling Rule); December 2003
        3. Bar Code Label Requirements for Human Drug Products and Biological Products; Final Rule; February 26, 2004 (Volume 69, Number 38)
      7. Pediatric Research Equity Act (PREA) December 2003
      8. Guidance for Industry: Providing Regulatory Submissions in Electronic Format- Content of Labeling (April 2005)
      9. Guidance for Industry; Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (July 2001).
      10. Guidance for Industry; Contents of a Complete Submission for the Evaluation of Proprietary Names (February 2010)
      11. Guidance for Industry: Bar Code Requirements Questions and Answers
      12. SOPP 8001.4: Review of CBER Regulated Product Proprietary Names
      13. SOPP 8401: Administrative Processing of Biologics License Applications (BLA)
      14. SOPP 8405: Complete Review and Issuance of Action Letters
      15. SOPP 8411.1: Administrative Handling and Review of Annual Reports for Approved Biologics License Application (BLAs)
         
  10. History
  1. Comment / Revision
    Approved By
    Approval Date
    Version Number
    Comment
    Dixon, PerkinsRobert Yetter, PhDMar 21, 20124Revised to include Bar Code information
    Rehkopf/RMCCRobert Yetter, PhDOct 13, 20113Update to new format and processes
    L. Falk/RMCCRobert Yetter, PhD
    Mar 20, 2008
    2
    Update to include Physician’s Labeling Rule;
    Submission of labeling in Structured Product Labeling Format
     Robert Yetter, PhD
    Dec 23, 2002
    1
    Original version of SOPP