Owners or operators of drug manufacturing establishments are required to register their establishments with FDA. Registrants are also 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.
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. See eDRLS instructions for information and instructions on the electronic submission process.
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, including:
- Drug establishment inspections
- Post market surveillance
- Drug quality reports
- Adverse event reports
- Monitoring of drug shortages and availability
- Supply chain security
- Drug import and export
- Identification of products that are marketed without an approved application
Drug registration and listing information is also widely used outside FDA for several purposes, such as electronic prescribing and electronic health records, reimbursement and patient education. This is why correct and up-to-date information in FDA’s NDC Directory and other public drug listing databases is essential to protect public health.
See section 510 of the Federal Food, Drug, and Cosmetic Act and part 207 of Title 21 of the Code of Federal Regulations (CFR) for more information on the requirements for establishment registration and drug listing.
- Registration renewal occurs between October 1 and December 31 each year
- Listing updates may occur at any time in the calendar year
- Electronic Registration and Listing Compliance Program
- FDA reminds manufacturers and repackagers to update their drug listings with product identifiers (10/3/2018)
- Drug Registration and Listing Workshop Webinar (10/8/2020)
- Human drug compounding registration and product reporting procedures
- Human drug establishment registration and drug listing compliance course
- NDC Directory
- FDA drug establishment current registration site