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  5. ANNEX B - The Drug Listing Act of 1972 Information Bulletin
  1. Guidance, Compliance, & Regulatory Information

ANNEX B - The Drug Listing Act of 1972 Information Bulletin

ANNEX B - The Drug Listing Act of 1972 Information Bulletin

The Drug Listing Act of 1972 amended the Federal Food, Drug, and Cosmetic Act so that drug establishments that are engaged in the manufacturing, preparation, propagation, compounding, or processing of a drug are required to register their establishments and list all of their commercially marketed drug products with the Food and Drug Administration (FDA). This requirement includes establishments that repackage or otherwise change the container, wrapper, or labeling of any drug package in the distribution of the drug from the original place of manufacture to the person who makes final delivery or sale to the ultimate customer.

The Drug Listing Act applies to all drug firms manufacturing or processing human drugs, veterinary drugs and medicated animal feed premixes. Domestic firms purchasing bulk or finished drugs from foreign companies should inform representatives of those companies that all drugs imported into this country must be listed by the foreign firm or its designated U.S. agent. All drugs exported by domestic firms, whether in bulk or finished dosage forms, must similarly be listed.

The first listing was required to be submitted to the FDA in June 1973. Drug products which are not properly listed are considered misbranded and may be subject to regulatory action. "Properly listed" means that all data provided to the FDA for each product is correct, including the trade name or proprietary name, if any, dosage form and route of administration, the ingredient information, package information, and the National Drug Code (NDC). After the initial product listing, firms are required to update their drug product listings twice yearly, by the end of June and December. However, it is preferable that changes in previous submissions and new product submissions be reported as soon as they occur. The NDC for one product may not be used for another. If any changes occur in product characteristics, including a change in dosage form, active ingredient(s), strength or concentration, route of administration, or product name, a new NDC number must be assigned to the new product version.

Form FDA-2656e is used for annual update of labeler code information. This information includes firm name, site address, mailing address, type ownership, etc. This form can also be used to report that the firm has gone out of business, ownership of firm has changed, or re-entry into business.

Under current FDA regulations, an establishment may be engaged in activities that would require registration with other offices within the Agency. For example, a firm may be required to register as a medical device establishment or as a processor of blood or blood products, as well as a drug establishment. On the other hand, an establishment may be subject to the registration requirements of both Medical Devices and the Center of Biologics, and not be required to register as a drug establishment. If the latter is the case, please make a notation on the enclosed copy of Form FDA-2656e and return it to us in the enclosed pre-addressed envelope, and we will remove your establishment from our drug registration file.