Important+Documents

FDA Contacts
Points of contact web page: [].

Acts and Regulations

 * [|FDA Amendments Act of 2007 - Section 224 - Electronic Registration and Listing]

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." > IMPLEMENTATION NOTE [02-Nov-2009]: //In the very near future, all **valid** new listing SPL documents associated with approved drug products should be posted for you to access via this link within 24 - 48 hours on business days. If you need the document posted right away for a submission then you can let us know via e-mail to// //SPL@fda.hhs.gov////. In that e-mail, you should send the document ID associated with the submission and we should be able to have it posted within a few hours after it is processed by the eList system. FDA// //should have all of the valid listing documents submitted prior to last week in the new repository within three weeks.//
 * [|Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing]
 * Electronic requests for Labeler Codes, Establishment Registrations and Drug Listings will be made via the FDA [|Electronic Submission Gateway](ESG) starting in June 2009.
 * [|Guidance to industry: Providing Regulatory Submissions in Electronic Format -- Content of Labeling (Final)]
 * [|Guidance for Industry: Indexing Structured Product Labeling](Final)
 * [|Guidance for Industry: Established Pharmacologic Class]
 * [|Draft Guidance for Industry and Reviewers on Structured Product Labeling Standard for Content of Labeling Technical Questions and Answers]

**To comment on a Draft Guidance electronically, use**

Implementation Guides (also known as "IG")
> > Structured Product Labeling Implementation Guide for FDA Drug and Biological Products v1.1 (updated January 16, 2007) > Structured Product Labeling Implementation Guide for FDA Drug Establishment Registration and Drug Listing v2.0
 * SPL R3 Implementation Guide v0.9
 * [|SPL R4 Implementation Guide v2.0]

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]** > @http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm > > Variations (Validation Rules only) from earlier version are > Variations from earlier version are here. > > Variations from earlier version are here. > New rules (compared with earlier version) are here in handy spreadsheet format: [!!Thanks pdesai!!] >
 * Combined Implementation Guide/Validation Procedures released December 2011:
 * [201008021527 on front page is the latest release of] Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing v2.0 [|PDF]
 * Previous version [[201005011423] of Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing v2.0 [|PDF]
 * [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

 * [|FDA SPL Schema for Implementation](zip file last updated July 10, 2008)
 * [|FDA SPL stylesheet] (last updated January 31, 2011) - send comments to spl@fda.hhs.gov

Docket Notifications for SPL Submission

 * Establishment of the [|Public Docket](Notice)
 * [|SPL Docket 92S-0251 - Drug Establishment Registration and Drug Listing]
 * [|SPL Docket 92S-0251 - Content of Labeling-CDER]
 * [|SPL Docket 92S-0251][|SPL Docket 92S-0251 - Content of Labeling - CBER][| - Content of Labeling - CBER]