August 13, 2019
“FDA regulations require all drug manufacturers to register their manufacturing facilities and provide a list of all drugs they are actively manufacturing for commercial distribution in the U.S. as one of the safeguards protecting our drug supply chain. It is vital that the FDA database accurately describes drugs currently available to patients in the U.S. so the FDA can more quickly respond to and assess drug quality issues, adverse event reports, inspections, recalls, shortages and other supply chain security issues,” said FDA Acting Commissioner Ned Sharpless, M.D. “While most companies are compliant, we have observed that some drug listings contain obsolete or inaccurate information. While there hasn’t been any public health consequence yet of these outdated listings, inaccurate information has the potential to compromise the integrity of the FDA’s database and the FDA’s ability to make accurate and timely decisions to protect public health. To ensure we’re working with the most updated and complete information, the agency is putting companies on notice that these outdated records will be inactivated. Products with inactivated listings may not be legally marketed in the U.S. until the company brings their records up to date. We’ll continue to enforce drug establishment registration and listing requirements, and we’ll work closely with manufacturers to ensure that registration or listing deficiencies do not affect the availability and quality of medicines for patients or result in drug shortages.”
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 Such outdated listings nonetheless compromise the integrity of the FDA’s database and the FDA’s ability to make accurate and timely decisions to protect public health.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.
Domestic and foreign establishments that manufacture, repack or re-label drugs in the U.S. are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their drug products manufactured for commercial distribution in the U.S. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the U.S. Drug manufacturers must provide registration and listing information or updates regarding any drug listing data changes twice each year, in June and December, or must certify that there have been no changes to previously submitted drug listing data by December 31 each year. The FDA has been actively working to alert companies of their issues, and this approach will help the agency ensure the integrity and accuracy of the FDA’s public databases. The agency urges companies to update inaccurate active drug listing submissions as soon as possible, as inactive listings as of September 12, 2019 will be removed from the database. Additional updating requirements and deadlines are available in the federal register notice below.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.