eDRLS Introduction

Requirements for drug establishment registration and drug listing are set forth in section 510 of the Federal Food, Drug, and Cosmetic Act (the Act) and section 351 of the Public Health Service Act (the PHS Act), and 21 CFR Part 207. Fundamental to FDA's mission to protect the public health is the collection of this information, which is used for important activities such as postmarket surveillance for serious adverse drug reactions, inspection of drug manufacturing and processing facilities, and monitoring of drug products imported into the United States. Comprehensive, accurate, and up-to-date information is critical to conducting these activities with efficiency and effectiveness.

Section 510 of the Act and 21 CFR part 207, subject to certain limited exceptions, require establishment owners and operators (registrants) upon first engaging in the manufacture, preparation, propagation, compounding, or processing of drugs, (including human drugs, veterinary drugs, and biological drug products) to register their establishments and submit listing information for all drugs in commercial distribution. Registrants are also required to submit registration information for their establishments on or before December 31 of each year. At the time of registration, registrants must also submit required listing information. Additionally, registrants are required to update listing information in June and December of each year to include information for drugs that have not been previously listed. Certain changes to information for previously listed drugs must also be submitted every June and December.

Drug establishment registration and drug listing information have, until now, been submitted using a paper-based format, i.e., Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments' Report of Private Label Distributors).

Changes in the Act, resulting from the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) (FDAAA), require that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted.

Beginning June 1, 2009, FDA no longer accepts paper submissions for drug establishment registration and listing unless a waiver is granted. Moving from a paper-based format to an electronic system will improve the timeliness and accuracy of the submissions.

For more information you can go to: Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Drug Establishment Registration and Drug Listing [PDF]