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 [email protected] 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 [email protected] 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 [email protected] 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 [email protected] with questions about human drug listings
- Contact [email protected] with questions about biologic listings
- See the electronic animal drug product listing directory for animal drug listing status. Contact [email protected] or call 240-276-9300 with questions
- Contact [email protected] with questions about device registration or listing
Regulatory questions or request for general information
- For human drugs, contact [email protected]
- For animal drugs, contact [email protected] or call 240-276-9300
- For biologics, contact [email protected] or call 301-827-0373