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U.S. Department of Health and Human Services

Drugs

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Form FDA 2656

Registration of Drug Establishment/Labeler Code Assignment - 
Paper Submission

Form FDA 2656

This form was historically used by all drug firms both domestic and foreign who are required to register and drug list products with the Food and Drug Administration.  This form was also used to provide updates in registration information annually or at the discretion of the registrant, when any changes occurred.

 

As of June 1, 2009, FDA only accepts electronic submissions for Registration and Listing unless a waiver is granted.  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

 

For more information, please visit Drug Registration and Listing.