Structured Product Labeling (SPL)

CDR Vada Perkins, USPHS Regulatory Program Management Officer FDA/CBER/OD

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.

CBER Notification
http://www.fda.gov/oc/datacouncil/spl.html 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.

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

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

Drug Registration and Listing (Paper) Forms

XML Structured Content

<time value="20080207"/> <assignedEntity> <id extension=VP00019" root="2.43.106.1.925856.8.422"/> <representedOrganization> <name>Greatest Pharmaceuticals</name> <addr>Metropolis, MA, USA</addr> </representedOrganization> </assignedEntity> </author>

SPL Stylesheet View/Source Code

Courtesy of Lonnie Smith, FDA

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. http://dailymed.nlm.nih.gov/dailymed/about.cfm

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format Drug Establishment Registration and Drug Listing (7/11/08)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 FDAs electronic system for this type of submission. Mandatory (1 June 09)

FDA eLIST
Inbound

TRANSMIT
(NLM Web) (Redacted Listing Files) DailyMed website

Industry

FDA ESG Gateway

Pass

REPOSITORY
.

eList
PROCESS
FDA Web
(Redacted Listing Files) FACTS@FDA website

VALIDATE
Fail
Outbound ERROR MESSAGE

DATA FILES
(Database Reports) Registration Listing NDC Directory & Establishments Websites

VALIDATION ERRORS

Validation of Structured Product Labeling Data Elements

Data Source SPL Documents

NDC LCR
Listing/CoL

Labeler Code: XXXXX

Labeler DUNS #: 354898887
Establishment Registration

Labeler Code: XXXXX

Labeler DUNS # 354898887 Establishment DUNS #(s) 111111111 Type of Operations

Establishment DUNS #(s) 111111111 Type of Operation(s) US Agent Importer(s)

Courtesy of Lonnie Smith, FDA

SPL Terminology
Only controlled terminology permitted in SPL. Terminology lists located on FDA Data Standards Councils SPL web page: http://www.fda.gov/oc/datacouncil/spl.html

SPL Terminology
Only controlled terminology is permitted in SPL documents Terminology lists are on FDA Data Standards Councils SPL web page: http://www.fda.gov/oc/datacouncil/spl.html
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

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

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

Thank You
General Questions: vada.perkins@fda.hhs.gov