The FDA maintains a catalog of drug products commercially distributed in the U.S. Regardless of country of origin, entities that manufacture, repack or re-label drugs in the U.S. are required to register with the FDA, and are required to list drug products manufactured for commercial distribution in the U.S.
The agency has found tens of thousands of drug listings that haven’t been updated (they may no longer be marketed or they are marketed and their listings haven’t been updated). In order keep up-to-date records and make “accurate and timely decisions to protect public health,” they intend to deactivate out-of-date listings, according to a news release.
“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. in the release.
The agency says inactive listings as of Sep. 12, 2019 will be removed from the database. They are urging companies to update inaccurate active drug listing submissions as soon as possible.
For more, see the news release and the federal register notice with updating requirements and deadlines.