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In this section: Electronic Drug Registration and Listing System (eDRLS)

Points of Contact for Drug Registration and Listing

Following are points of contact for specific questions about registration and listing for human drugs, animal drugs and biologics.

Electronic Submission Gateway (ESG) account

Contact ESGHelpDesk@fda.hhs.gov for ESG technical inquiries regarding opening a new gateway account.

Examples of questions for this point of contact:

How long does it take to open a new gateway account?
What should I submit in my letter of non-repudiation?
How do I obtain an x.509 digital certificate?

Structured Product Labeling (SPL)

Contact spl@fda.hhs.gov for technical help and inquiries regarding XForms.

Examples of questions for this point of contact:

Why did I get an error message with my XForms submission? What does it mean?
What are the validation procedures?
How do I send product labels in my XForms submission?

Establishment registration status

Contact edrls@fda.hhs.gov for questions and assistance with registration. See the drug establishment current registration site to check a facility’s current registration.

Examples of questions for this point of contact:

I registered for the current year but the drug establishment current registration information still shows last year’s registration. Why did this happen?
Why does my facility appear twice in drug establishment current registration?
I submitted my registration with the correct spelling of the facility’s name but it’s wrong in drug establishment current registration information. How did it happen? Can you fix it?

Drug listing status

See NDC Directory for human drugs and biologics listing status
Contact edrls@fda.hhs.gov with questions about human drug listings
Contact CBERSPL@fda.hhs.gov with questions about biologic listings
See the electronic animal drug product listing directory for animal drug listing status. Contact AskCVM@fda.hhs.gov or call 240-276-9300 with questions
Contact reglist@cdrh.fda.gov with questions about device registration or listing

Regulatory questions or request for general information

For human drugs, contact edrls@fda.hhs.gov
For animal drugs, contact AskCVM@fda.hhs.gov or call 240-276-9300
For biologics, contact CBERSPL@fda.hhs.gov or call 301-827-0373

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