Electronic Drug Registration and Listing Instructions with the U.S. FDA

1. Overview

The FDA’s Electronic Drug Registration and Listing System (eDRLS) is the electronic system used for registering drug establishments and listing drug products. Submissions are made in Structured Product Labeling (SPL) format using XML files transmitted through the FDA’s Electronic Submissions Gateway (ESG). Source: https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-drug-registration-and-listing-instructions

2. Who Must Register

Any establishment that manufactures, repacks, relabels, or salvages drug products for U.S. commercial distribution must register with FDA. Certain exemptions apply for pharmacies, hospitals, and research facilities. Foreign establishments must designate a U.S. agent. Source: https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-drug-registration-and-listing-instructions

3. Registration Requirements

Establishments must register within 5 days of beginning to manufacture or distribute drugs. Annual renewal is required between October 1 and December 31 each year. Registration includes establishment details, DUNS number, business operations, and contact information. Source: https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-drug-registration-and-listing-instructions

4. Labeler Code

A labeler code is required to generate National Drug Codes (NDCs). It is assigned by FDA upon request and must be included in product listings. Companies typically need only one labeler code. Source: https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-drug-registration-and-listing-instructions

5. Drug Listing Requirements

All registered establishments must list every drug they produce for U.S. distribution under their labeler code. Listings include product details, active and inactive ingredients, labeling, and manufacturing establishment information. Initial listings must be submitted within 3 days of registration. Source: https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-drug-registration-and-listing-instructions

6. Updates and Certifications

Changes to registration or listings must be updated promptly. A blanket 'no change' certification can be submitted annually for unchanged listings. All submissions must pass validation. Source: https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-drug-registration-and-listing-instructions

7. Practical Considerations

Manufacturers should use CDER Direct or validated SPL authoring tools. Successful registrations appear in the Drug Establishment Current Registration Site (DECRS). NDC assignment does not imply FDA approval. Source: https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-drug-registration-and-listing-instructions