FDA Takes Measures to Clean Its Drug Registration Database in 30 Days   
[Thursday, August 15, 2019]

FDA drug establishment database is filled with tens of thousands of outdated entries for drugs that are no longer being marketed. In 30 days, FDA will remove all such listings to assure that the drugs establishment list contains only those that are current. The drug established database is critical for FDA’s regulation of the drug manufacturing sites. FDA relies on its database of registered facilities to manage and regulate drug manufacturing facilities such as identifying facilities for compliance audits, collect post-marketing surveillance data, manage recalls, drug quality reports, adverse event reports, monitoring of drug shortages and availability, supply chain security, and identification of products that are marketed without an approved application. The outdated entries create an obvious challenge for FDA and hence it wants to clean the database. FDA issued a notice to all manufacturers of drugs to update their listings by 12 Sep 2019 or risk being inactivated and get their NDC codes get inactivated as well. Since most of those listings are for drugs that are no longer marketed, this should not affect the supply chain. Thereafter FDA would keep the database clean by removing all outdated registrations every January and July. However, the inactivation, will not be permanent. Once inactivated, the manufacturers can reactivate the inactivated listing by submitted the updated information to the drug listing database and the inactivated entry could be reactivated quickly.