This form was historically used by all registrants to submit a listing for every product in commercial distribution, and private label distributors who elect to submit listing information to FDA for products they distribute. This form was also used to provide updates to product listing information every June and December or at the discretion of the registrant, when any change 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.