Drug Registration and Listing
The OC uses qualitative and quantitative data analysis and strategic problem solving to target compliance actions and develop innovative compliance strategies to reduce public health risks associated with violative products. The Drug Registration and Listing (DRLS) 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.
