Under 21 CFR 207.57(b), registrants must submit updated listing information at each June and December if there is change since the previous listing and they must submit this information to the FDA via electronic format, These changes include any drug recently introduced in the U.S. commercial distribution which was not previously listed, any drug which commercial distribution has been ceased, any drug reintroduced in commercial distribution and any material changes in any drug listing information previously submitted.
After initial electronic listing, registrants may satisfy the listing certification requirement with respect to unchanged listing information by submitting annual blanket no changes certification of product listing.
At the time of the annual registration update under Sec. 207.29(b), a registrant may submit a blanket “no changes” certification covering all of its listed drug products for which no changes to reported listing information were made since the last annual registration update or listing submission. This blanket certification applies only to drug listing information that has been submitted electronically.
Any NDC which has not been newly submitted or updated during the calendar year, or certified during the October to December registration renewal period will be considered expired on January 1st of the following year. All expired listings will be removed from publication in the NDC Directory and if you fail to comply with these requirements your products will be considered as adulterated and misbranding.
We, at pragmatic offer No Change Certification for product listing. We offer these services for $ 299 for 10 products no change certification, for each set of additional 10 products $ 25 fees is applicable. It takes 2 working days to complete the no change certification. Send us your labeler code and we will take prepare of change certification and submit to FDA.