FDA takes new steps to improve drug supply chain integrity and patient safety by announcing its intention to begin deactivating outdated drug listing records in its database

FDA takes new steps to improve drug supply chain integrity and patient safety by announcing its intention to begin deactivating outdated drug listing records in its database

Today, the U.S. Food and Drug Administration announced that it will inactivate listing records in its database that have not been recently updated or certified, as required by regulation, or that include an establishment with an expired registration. The agency has found that tens of thousands of drug listing records have not been updated or certified in the past year, and are therefore not in compliance with federal regulations, which can slow down surveillance operations for certain FDA programs. Many of these listings are for products that are no longer being marketed in the United States, but for which the manufacturer never updated the listing. Such outdated listings nonetheless compromise the integrity of the FDA’s database and the FDA’s ability to make accurate and timely decisions to protect public health. Listing records that are up to date are publicly available in the FDA’s National Drug Code Directory. Drugs with inactivated listing records may not be legally marketed or imported in the U.S.

Find details in the FDA In Brief: FDA takes new steps to improve drug supply chain integrity and patient safety by announcing its intention to begin deactivating outdated drug listing records in its database.