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U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

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Presentation on theme: "U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only."— Presentation transcript:

1 U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

2 Structured Product Labeling (SPL) CDR Vada Perkins, USPHS Regulatory Program Management Officer FDA/CBER/OD

3 BACKGROUND Federal Register of December 11, 2003 (68 FR 69009) FDA published final regulations requiring that the content of labeling be submitted electronically “in a form" that FDA can process, review, and archive. CDER announced in public docket number 92S-0251 the following new procedures for electronic submission of content of labeling, effective October 31, 2005: –PDF is no longer a format FDA can use to accept the content of labeling submitted electronically. –Applicants should use the SPL standard when submitting all labels, labeling supplements, and amendments to FDA in XML.

4 CBER Notification Subject: Docket 92S-0251 – Transmittal Effective Date: October 15, 2008 –Notification established Health Level Seven (HL7) Structured Product Labeling (SPL) in XML as the only acceptable presentation in electronic format for the submission of the content of labeling –Applicable to the content of labeling with original submissions, supplements, and annual reports.

5 Structured Product Labeling (SPL) Electronic labeling standard developed by Health Level 7 (HL7) –Utilizes eXtensible Markup Language (XML) Machine readable tags to improve search functionality across systems –Usability across multiple database platforms –Promote electronic health information initiatives –Enhance search capabilities

6 Current State  Limited in:  Readability  Accessibility  Usability  paper labels and forms cannot be accessed by computer systems

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8 Drug Registration and Listing (Paper) Forms

9 XML Structured Content Greatest Pharmaceuticals Metropolis, MA, USA

10 Courtesy of Lonnie Smith, FDA SPL Stylesheet View/Source Code

11 Benefits of SPL  Improved access  Computer Readable  Locate a specific section of the labeling and specific elements within labeling and product listing sections.  Information Systems  XML easily imported into information systems for other uses (e.g., data mining).  Publicly available  Content of Labeling is made available by the FDA thru NLM (DailyMed) to consumers and health care providers. 

12 Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (7/11/08 ) Voluntary Pilot Program –NDC Labeler Code Request –Establishment Registration –Drug Listing/Content of Labeling Guidance covers: –How to submit the information electronically in Structured Product Labeling (SPL) files, using a defined terminology. –Transition from paper-based to electronic submissions of drug establishment registration and drug listing information. –What registration and listing information (including labeling) to submit. –Test the performance of FDA’s electronic system for this type of submission. –Mandatory (1 June 09)

13 Validation of Structured Product Labeling Data Elements DailyMed website Fail FDA eLIST VALIDATE eList website REPOSITORY. TRANSMIT (NLM Web) (Redacted Listing Files) PROCESS DATA FILES (Database Reports) Registration Listing VALIDATION ERRORS FDA Web (Redacted Listing Files) Industry NDC Directory & Establishments Websites FDA ESG Gateway Outbound Inbound ERROR MESSAGE Pass

14 Courtesy of Lonnie Smith, FDA Data Source – SPL Documents NDC LCR Listing/CoL Establishment Registration Establishment DUNS #(s) Type of Operation(s) US Agent Importer(s) Labeler Code: XXXXX Labeler DUNS # Establishment DUNS #(s) Type of Operations Labeler Code: XXXXX Labeler DUNS #:

15 SPL Terminology Only controlled terminology permitted in SPL. Terminology lists located on FDA Data Standards Council’s SPL web page:

16 SPL Terminology Only controlled terminology is permitted in SPL documents Terminology lists are on FDA Data Standards Council’s SPL web page: Route of administration Dosage form Package type Units of measure and units of presentation Color Shape Coating Size Scoring Imprint codes Symbols SPL DEA Schedule Section headings Code system object identifiers (OIDs) Document Type including Content of Labeling Type Time Units: Unified Code for Units of Measure (UCUM) Substances/Unique Ingredient Identifiers (UNIIs) Business Operation Marketing Category Marketing Status Equivalence Codes

17 Listserv  FDA Data Standards Council Website –http://www.fda.gov/oc/datacouncil/http://www.fda.gov/oc/datacouncil/

18 Acknowledgements  Lonnie Smith, FDA/Office of Critical Path Programs  Randy Levin, MD, FDA/Office of Critical Path Programs

19 Thank You General Questions:


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