Division of Compliance Risk Management and Surveillance

Drug Registration and Listing System (DRLS)

The Division of Compliance Risk Management and Surveillance oversees the Drug Registration and Listing System (DRLS), a key component of the FDA’s ability to monitor drug safety. All 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. The listing must include the trade name or proprietary name, if any, of the drug, dosage and route of administration, ingredients, package information, and the National Drug Code. Drug products which are not listed are misbranded and may be subject to regulatory action.

All 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. 

• Drug Registration and Listing Instructions. This site provides the FDA’s instructions on drug registration and listing, including applicable forms and guidance.
• Form FDA-2656 Registration of Drug Establishment/Labeler Code Assignment . Links to FDA Form 2626 Registration of Drug Establishment/Labeler Code Assignment.
• Form FDA-2657 Drug Product Listing . Links to FDA Form 2657 Drug Product Listing.
• Form FDA-2658 Registered Drug Establishment's Report of Private Label Distributors . Links to FDA Form 2658 Registered Drug Establishment’s Report of Private Label Distributors.
• National Drug Code Directory. Links to the National Drug Code (NDC) Directory. The NDC serves as a universal product identifier for human drugs.
• 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.
• 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.

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