The Drug Listing Act of 1972, amending the Federal Food, Drug, and Cosmetic Act, became effective February 1, 1973. Its purpose is to provide the Commissioner of the Food and Drug Administration (FDA) a current list of all drugs manufactured, prepared, propagated, compounded, or processed by a drug establishment registered under the Federal Food, Drug, and Cosmetic Act. Until 1973, the FDA had no means of obtaining this information except by periodic inspection of registered establishments. This act requires submission of information on commercially marketed drugs and is a substantial help in the enforcement of the Federal Food, Drug, and Cosmetic Act.

All drug establishments, foreign and domestic, must list all of their drug products in commercial distribution in the United States.

Drug products should be submitted at the same time the drug establishment submits Form for registration or labeler code assignment. After the initial listing, drug establishments are required to update their drug listing information twice yearly (the end of June and December). However, changes in the formulation, labeling, packaging, manufacturing site, etc., are to be reported as soon as they occur.