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. 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 Back to Top Compliance Risk Management and Surveillance FDA/Center for Drug Evaluation and Research |