This form was historically used by manufacturers reporting listing information for those private label distributors that did not elect to submit listing information directly to FDA. This form was also used to provide updates to product listing information every June and December or at the discretion of the manufacturer, 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.