REMINDER: Annual Blanket No Changes Certification of DRUG Product Listing

This is a reminder regarding the FDA’s recent drug certification requirements.  Under the FDA’s new drug certification requirements, products that were not initially listed or updated during 2018 must be certified that their previously submitted drug listing information has not been changed.  The product listing certification period using the Blanket No Changes Certification of Product Listing SPL submission runs from October 1 through December 31.

Under 21 CFR 207.57(b), registrants must electronically submit updated listing information to the FDA if there is any change to listing information since the previous submission each June and December.  Changes can include any drug that was recently introduced or reintroduced to commercial distribution in the U.S. and any material changes in any drug listing information that was previously submitted.

After the initial electronic listing, registrants can make a “no changes” certification to satisfy the listing certification requirement with respect to unchanged listing information.  At the time of annual registration updating, a registrant can then submit a blanket “no changes” certification covering all of its listed drug products for which no changes have been made to the reported listing information since the last listing submission.  A “no changes” certification can be submitted by creating a new blank “no changes” certification of product listing SPL document, filling out the required data elements, and then submitting the document.

Failure to submit an update or certification by the deadline may result in FDA action including deactivation of the listing record and removal from the NDC directory.  More information on registration and the listing process can be found on the Electronic Drug Registration and Listing System website.

The Deadline to be in compliance with the FDA’s requirement is fast approaching. Contact us don’t be out of compliance!! 

We at mdi can assist with any of your listing and certification and registration needs. 

? For any questions or comments or your regulatory requirement please email to [email protected] or use our contact form. RE: Drug Certification.