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U.S. Department of Health and Human Services

Drugs

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Electronic Drug Registration and Listing Instructions

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New to eDRLS!  

 The new NDC Directory was updated on June 1st, 2011. Below are data definitions for the redesigned files.
 

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.

As of June 1, 2009, FDA no longer accepts paper submissions for drug establishment registration and listing 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 submit drug establishment registration and drug listing electronically:

  • Go to: Electronic Submissions Gateway and obtain an gateway account.
  • Go to: D & B website and request a DUNS number.
  • Prepare the SPL. For more information you can go to the Structured Product Labeling Resources website.
  • Send your SPL through the Gateway to the OC center.
  • You will receive an electronic receipt if your file goes through Gateway. 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.              

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

 

To facilitate the submission of drug establishment registration and drug listing information (including labeling as specified under 21 CFR 207.25), FDA is adopting the use of extensible markup language (XML) files in a standard SPL format. The automated submission process functions most efficiently and effectively when this information is provided in a standardized format with defined code sets and codes. This guidance and accompanying technical documents describe how to make these submissions using the SPL format, which FDA can process, review, and archive. Information in a properly created and complete SPL file can facilitate processing and allows for greater precision and accuracy through the use of coded data fields rather than just electronic text. Receipt of timely and accurate information will enhance FDA's efforts to help ensure the integrity of the drug supply and protect public health.
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) Filesfor Drug Establishment Registration and Drug Listing
  • Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing

SPL format is already used for submission of content of labeling in electronic format as required in New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Biological License Applications (BLAs), and annual reports on approved drugs. See Providing Regulatory Submissions in Electronic Format -Content of Labeling (April 2005). Because the content of labeling required under those provisions can be duplicative in content and format (SPL) of the labeling required to be submitted electronically as part of listing information, FDA encourages applicants to submit this labeling material, and updates, primarily through the drug establishment registration and drug listing system. Rather than make duplicate submissions, applicants are then encouraged to reference the SPL labeling file submitted through the electronic drug registration and listing system in making labeling updates to applications under the content of labeling requirements. FDA intends to issue guidance that will address this issue in further detail.

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.

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