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U.S. Department of Health and Human Services

For Industry

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Drug Registration and Listing System

Requirements for drug establishment registration and drug listing are set forth in Section 510 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), Section 351 of the Public Health Service Act (the PHS Act), and in the Code of Federal Regulations (CFR) Title 21 Part 207.

Changes in the FD&C Act, resulting from the Food and Drug Administration Amendments Act (FDAAA) of 2007 (Public Law 110-85), require that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted. As a result, since June 1, 2009, the 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 your reference, see Guidance - Drug Establishment Registration and Drug Listing.

IMPORTANT! To submit your file to the FDA, you must first obtain a WebTrader account with the FDA Electronic Submission Gateway (ESG). To do this, visit the Setting up a WebTrader Account Checklist.