Drug Registration and Listing
The Drug Registration and Listing (DRLS) program is a key component of FDA's ability to monitor drug safety. DRLS was established to help protect the public from adulterated and misbranded drugs. Domestic and foreign establishments that manufacture, repack or re-label drug products in the United States are required to register annually with FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are required to list all of their commercially marketed drug products. This information helps 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.
FDA relies on registration, listing and U.S. agent information to administer 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.
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 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.