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U.S. Department of Health and Human Services

Drugs

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Electronic Drug Registration and Listing Instructions

With the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) (FDAAA), as of June 1, 2009 registration and listing with Forms FDA 2656, 2657 and 2658 was discontinued. Electronic submission is now required unless a waiver is granted. Moving from a paper-based format to an electronic system has improved the timeliness and accuracy of the submissions.

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).

New Information

  • 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24, 2018 if the device is not required to bear a UDI on its label, any NHRIC or NDC number assigned to a device is rescinded and may no longer be on the label.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/udi 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.

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.

The process for establishing an ESG account may involve a delay before drug registration and listing information can be received electronically by FDA. FDA encourages owners and operators subject to registration and listing to establish their ESG accounts as soon as possible; establishing an ESG account 4-6 weeks in advance of the time when the owner or operator must register, list, or update a registration or listing will best ensure that electronic submissions are not delayed. SPL files including all image files are then placed in a folder and sent through the FDA Gateway. 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”.

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.

To create the SPL formatted XML file firms generally use a tool. Some firms may have a document management system which contains this functionality. Other firms will need to obtain a tool. There is a free tool available through FDA; XForm.

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
 

Additional SPL resources:
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:

  • Structured Product Labeling Implementation Guide for FDA Drug Establishment Registration and Drug Listing
  • Step-by-Step Instructions for Creating Structured Product Labeling (SPL) Files for Drug Establishment Registration and Drug Listing 
  • Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing


Verify Submission Status

Please note that the accuracy of the data submitted on the SPL, will be validated. 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.
Registration:
Registration information can be verified on Drug Establishment Current Registration Site (DECRS): http://www.fda.gov/Drugs/InformationOnDrugs/ucm135778.htm.
DECRS is updated daily. Questions can be directed to: eDRLS@fda.hhs.gov.

Labeler Code Request:
If a firm is already assigned a labeler code, the existing labeler code must be included on the Labeler Code Request SPL. This will enable the firm to submit electronic drug listing SPLs. If you’re requesting a new labeler code, you’ll be notified of the assignment through an official email. Once all the requested information is provided, allow 30 days to receive the assignment notification. To check the status after 30 days, you can send an email to: eDRLS@fda.hhs.gov.

Listing:
Listing status for most drugs can be checked on FDA’s NDC Directory, which is updated daily: http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm.
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:

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 (HF-18)
Room 12B-16
5600 Fishers Lane
Rockville, MD 20857-0001
Phone: 1-888-463-6332
 

If you are granted a waiver, you will be instructed as to how to submit the registration and listing information.

For Technical questions contact: SPL@fda.hhs.gov
For Regulatory questions contact: eDRLS@fda.hhs.gov