FDA aims to improve drug supply chain integrity, patient safety

Aug. 14, 2019
Tens of thousands of drug listing records have not been updated or certified in the past year.

The Food and Drug Administration announced that it plans to 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 Such outdated listings nonetheless compromise the integrity of the FDA’s database and the FDA’s ability to make accurate and timely decisions to protect public health.

“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,” said FDA Acting Commissioner Ned Sharpless, MD in the statement. “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.” FDA says no public health issues have resulted yet.

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 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.

“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,” Sharpless said. “Products with inactivated listings may not be legally marketed in the U.S. until the company brings their records up to date.”