Registration of Drug Establishment/Labeler Code Assignment -
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:
U.S. Food and Drug Administration (HF-18)
5600 Fishers Lane
Rockville, MD 20857-0001
For more information, please visit Drug Registration and Listing.