Electronic Drug Registration and Listing System (eDRLS)
Drug manufacturers are required to register their establishments with FDA. Registrants also are required to list each drug manufactured at their establishment(s) intended for commercial distribution and submit updated drug listing information to FDA twice each year, in June and December, notifying FDA if this information has changed.
Registering an establishment and listing drugs with FDA does not indicate the products are approved or that FDA has verified the information provided. Complete, accurate and up-to-date establishment registration and drug listing information is essential to promote patient safety. FDA relies on establishment registration and drug listing information for several key programs such as inspections, postmarket surveillance, recalls, supply chain resiliency, counterterrorism and more.
Submitting data to FDA
Establishment registration and drug listing data are submitted electronically using structured product labeling (SPL) format. This provides the agency with a list of all drug manufacturers currently producing drugs for sale in the U.S. and a current inventory of all drugs in the U.S. supply chain.
Parts of the data are published in the FDA National Drug Code Directory, FDA label repository, FDA drug establishment current registration site and NIH’s DailyMed. Visit eDRLS instructions for information and instructions on the electronic submission process.
