Important FDA Documents for SPL


FDA Contacts

Points of contact web page: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/ucm254946.htm.

Acts and Regulations


Guidance Documents

"... Beginning June 1, 2009, FDA intends to no longer accept drug establishment registration and drug listing information in paper format unless a waiver is granted."

To comment on a Draft Guidance electronically, use

//Regulation.gov//

Implementation Guides (also known as "IG")


FDA SPL Starter Pack

[updated information 19-July-2010]
The FDA Data Standards Council SPL web page now includes a "SPL Starter Package."


FDA SPL Supporting Documents

[24-Aug-2010: New Revision of Validation Rules]
  • Combined Implementation Guide/Validation Procedures released December 2011:
    http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm

    Variations (Validation Rules only) from earlier version are
  • [201008021527 on front page is the latest release of] Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing v2.0 PDF
    Variations from earlier version are here.

  • Previous version [[201005011423] of Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing v2.0 PDF
    Variations from earlier version are here.
    New rules (compared with earlier version) are here in handy spreadsheet format: [!!Thanks pdesai!!]
  • [200908241430 on front page is the previous release of] Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing v2.0 PDF Variations from earlier version are here.
  • Instructions for using Electronic Drug Establishment Registration and Drug Listing XForms v2.0 PDF
  • SPL Standard for Content of Labeling Technical Questions and Answers HTML
  • Electronic Labeling Information Processing System (ELIPS) Validation and Conformance Rules PDF

Data Standards Manual


Data Standards Manual

Controlled vocabulary links:

SPL Schema and Stylesheet


Docket Notifications for SPL Submission