Drug Registration and Listing System (DRLS & eDRLS)

The Office of Compliance Risk Management and Surveillance oversees the Drug Registration and Listing System (DRLS) and the new electronic Drug Registration and Listing System (eDRLS), key components of the FDA’s ability to monitor drug safety.

 

As of June 1, 2009, FDA no longer accepts drug establishment registration and drug listing information in paper format unless a waiver is granted. For more information you can go to:

 

• Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Drug Establishment Registration and Drug Listing (PDF - 776KB)

 

• FDA Resources for Standards

 

• eDRLS Instructions

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA.  Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States. Drug products that are not properly listed as required are misbranded and may be subject to regulatory action.

 

Foreign establishments that manufacture, repack, or re-label drug products and import or offer for import drug products to the United States must register with the FDA and identify a U.S. agent. All drugs imported into the United States must be listed by the foreign firm or its designated U.S. agent. 

 

The FDA relies on registration, listing, and U. S. agent information for administering many key programs, including postmarketing surveillance; user fee assessments; counterterrorism; monitoring of drug shortages and availability; and determining products that are being marketed without an approved application.

 

Related Resources

 

• Guidance for Industry May 2009 (PDF - 776KB).  Final Guidance for Industry on the new electronic Drug Registration and Listing System (eDRLS)

 

• National Drug Code Directory. Links to the National Drug Code (NDC) Directory. The NDC serves as a universal product identifier for human drugs.
      
• Summary of Registration and Listing Requirements for the Manufacture or Distribution of Human Pharmaceuticals

 

• CFR Part 207 – Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution. Links to the applicable section of the Code of Federal Regulations detailing registration of producers of drugs and listing of drugs in commercial distribution.

 

• FDA Proposal to Amend part 207. Federal Register Notice, 71 FR 51276 (August 29, 2006)

 

• Section 510 of the Food Drug and Cosmetic Act.  Links to the section of the Act requiring manufacturers, repackers, and re-labelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and human biological products to register their establishment(s) and submit a listing of every product in commercial distribution to the FDA.