Notice of intent to inactivate outdated drug listing records.

The FDA has announced its intention to begin inactivating drug listing records that are not properly listed in accordance with FDA requirements because these drug listings are not certified as being active and up to date; or are associated with a manufacturing establishment that is not currently registered with FDA.

According to the FD&C Act and the FDA’s Code of Federal Regulations (CFR), drug manufacturing companies are required to register their establishments with the FDA. Registrants are also required to “list” each drug that is manufactured at their facilities and later commercially distributed. They are also required to submit updated drug listing information to the FDA twice yearly to notify the FDA if this information has changed. Notifications may include the discontinuation of a drug and a change in manufacturing establishments.

The FDA has found that many listings for drugs products are not up to date, have not been certified as up-to-date, or a manufacturing establishment is not currently registered with the FDA. Many drugs in these listings appear to no longer be in commercial distribution. Complete, accurate, and up-to-date registration and drug listing information is important for the FDA to take care of the many responsibilities and programs they have including drug establishment inspections, monitoring of drug shortages and availability, and identifying products that are marketed without an approved application.

The purpose of this notice is to remind registrants of their legal obligations and announce that, if drug listings are not appropriately updated, certified, or associated with a registered establishment, they will be marked by the FDA as “inactive” drugs, and the date of inactivation will be added to the listing record. This process will result in the temporary closure of drug records in all public drug listing databases maintained by FDA, including the National Drug Code (NDC) Directory and the NDC SPL Data Elements (NSDE) file, until corrections to the relevant listings are made. The FDA encourages companies to update their drug listings immediately because outdated listing files will be inactivated and removed from databases starting September 12, 2019. Listing requirements and deadlines can be found on the federal register notice and more detailed instructions on drug registration and the listing process can be found on the FDA web page titled, “Electronic Drug Registration and Listing Instructions”.

mdi Consultants has been assisting our pharmaceutical clients in updating their establishment registrations and their DRUG LISTINGS. If you would like to discuss our drug listing services do not hesitate to contact us.

We will continue to monitor any updates pertaining to drug listing records moving forward. If you have any questions about drug listing requirements, cGMP compliance, and how this can affect your company, or for any of your regulatory requirements feel free to contact us at [email protected] or use our contact form.