Drugs

Electronic Drug Registration and Listing Instructions

With the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) (FDAAA), electronic submission is now required unless a waiver is granted. To facilitate the submission of drug establishment registration and drug listing information (including labeling as specified under 21 CFR 207.25), FDA adopted the use of Extensible Markup Language (XML) files in the Structured Product Labeling (SPL) format. To transmit the SPL formatted submission, firms must use the FDA’s Electronic Submission Gateway (ESG).

In order to complete an SPL submission, it is necessary to include firm’s DUNS number. For more information visit: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162544.htm.

New Information

  • CDER Direct is now available for Registration and Listing! See below for description.
  • Human Drug Compounding Registration And Product Reporting Procedures
  • FDA has stopped issuing National Health Related Items Code (NHRIC) and National Drug Code (NDC) labeler codes to manufacturers for use with medical devices.  Under 21 CFR 801.57, after the date the device must bear a unique device identifier (UDI) on its label or on September 24, 2018 if the device is not required to bear a UDI on its label, any NHRIC or NDC number assigned to a device is rescinded and may no longer be on the label.  A labeler may continue to use an NHRIC or NDC labeler code under a system for the issuance of UDIs if the labeler submits a request for continued use of the labeler code to FDA by September 24, 2014 and receives approval for continued use.  To receive instructions for requesting continued use of an NHRIC or NDC labeler code, please submit a question at the UDI help desk: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ucm368904.htm
Please see Summary of Compliance Dates for the UDI Final Rule, www.fda.gov/udi3 to determine when your device must bear a UDI on its label. Labelers may begin adopting UDIs for unique product identification rather than request NHRIC or NDC labeler codes for their devices prior to the device’s compliance date.  Please contact an FDA-accredited issuing agency to obtain a UDI.  Also, please note that under 21 CFR 801.30(b), a combination product may still bear an NDC number on its label.
Any SPL authoring software may be used to create registration and listing SPL files. The FDA offers two SPL authoring tools, CDER Direct and Xforms. Both are available from the FDA Website.

CDER Direct
CDER Direct is a free on-line tool that allows pharmaceutical firms to create, review, save, and submit certain SPL files through the ESG without the need of a WebTrader account or digital certificates. It features a forms-like data entry interface and provides tutorial slides, descriptive text, helpful links, and submission status.

Xform
Xform is a software tool for creating XML format which provides user interface for the XML data. Xforms can be accessed via the link below: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm189651.htm

SPL files including all image files are then placed in a folder and sent through the ESG. The name of the “center” and the “type of submission” are used to properly route the files.  For electronic drug registration and listing, the center is “OC” and the type of submission is “SPL”.

SPL Resources
:
Helpful information about SPL, including links to applicable guidances, training material, and terminology code sets can be found at:
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
Technical specifications for creation of the electronic files are provided in the following technical documents, which can be found on the FDA Data Standards Council website:

Electronic Submissions Gateway
The ESG is an agency-wide entry point for various electronic submissions. The ESG authenticates and validates electronic submissions and routes it to the appropriate Center. In order to use the FDA’s Electronic Submission Gateway firms must apply for an ESG Account. To obtain an ESG account go to: http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm114831.htm.
Possible errors associated with the submission, will generate a notification email with the detailed information on the type of error and will be sent to the firm’s ESG account. If the SPL file fails validation you will receive an error report within 24-72 hours. At this time, companies will not receive automatic confirmation if their submission passes validation.

Verify Submission Status
Please note that the accuracy and completeness of the data submitted on the SPL, will be validated.  Registration information can be verified on Drug Establishment Current Registration Site (DECRS). DECRS is updated daily. Listing information for finished drug products can be verified on the NDC Directory website. The NDC Directory does not include animal drugs, blood products, or human drugs that are not in final marketed form, such as Active Pharmaceutical Ingredients(APIs), drugs for further processing, drugs manufactured exclusively for a private label distributor. To check the listing status for these products send an email to:
Questions can be directed to: eDRLS@fda.hhs.gov.

Labeler Code Request:

To request a new labeler code for your company for use in NDCs, submit a labeler code request SPL file with the NDC Labeler Code field left blank. Once all the requested information is provided, allow 30 days to receive the assignment notification via email to the contact email address in the request. To check the status after 30 days, you can send an email to: eDRLS@fda.hhs.gov.
For updates to the labeler code assignment (including official name changes, changes to contact information, and companies who were assigned the labeler code via paper and are listing for the first time), the existing labeler code must be included in the NDC Labeler Code field in the Labeler Code Request SPL. This will enable the firm to submit electronic drug listing SPLs.

Waiver
To apply for a waiver from the requirement to electronically submit drug establishment registration and drug listing information, provide a written request with a complete explanation of why use of electronic means is not reasonable for you. Submit the request to:
SPL Coordinator
U.S. Food and Drug Administration (HFD-001)
10903 New Hampshire Avenue
Building 32, Room 2231
Silver Spring, MD 20993
 
If you are granted a waiver, you will be instructed as to how to submit the registration and listing information. 

Page Last Updated: 09/17/2014
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