Yes, you read that correctly. There are significant changes coming to the FDA’s electronic Drug Registration and Listing System (eDRLS) that require action from most drug labelers before the end of the year.
You may have heard that, as part of the eDRL Final Rule released last year, drug product labelers must certify annually that all drug product listings that have not already been updated during the calendar year are unchanged. Drug product labelers (or manufacturers listing products on their behalf) have been required for many years to submit any changes to their drug labeling or listing information to FDA as they occur. Until now, however, product listings could remain evergreen in the NDC directory, as long as there were no updates to the content.
The annual reporting period is the same for this submission as for Drug Establishment Registration, i.e., October 1 through December 31 for the coming calendar year. The chart below shows the timing of the No Changes Certification reporting period alongside other reporting periods established throughout the year by FDA for drug product submissions.
Initially, FDA had indicated that the No Changes Certification would be accomplished through resubmitting the NDC Labeler Code Request during the reporting period, which would signal to the agency that all associated NDCs that had not yet been updated during the calendar year were unchanged. However, during a recent call with the SPL Technical Team, FDA representatives indicated this will instead be handled through a new SPL document type, called a “Blanket No Changes Certification.”
This new submission type contains three sections—authorized agent information, manufacturing establishment data and the NDC Product Code of each product being certified.
Impact to Industry: What this Means for You
The 2016 eDRL Final Rule remains in full effect, so it is important for industry members to understand that this new submission requirement will apply to their organizations this year, meaning all labelers or their manufacturers must make a submission before the end of the year. The only exception to this rule is companies who have already updated all of their existing NDC product listings this calendar year. (Companies with a small number of listings may decide instead to update each drug listing file before the end of the year, with changes to the Version Number, Doc ID and effective dates.)
In order to make the No Changes Certification submission, labelers will need to have a good understanding of the last time each of their NDC product listings has been updated. They will also need to collect and double check the Establishment Registration information for each of the manufacturing sites associated all NDC Product Codes. Depending on the state of your records, this may take some time, so we advise beginning this process immediately—please do not wait until December. You may find you have some detective work to do, especially if it has been a long time since you have needed to perform updates or if the person previously in charge of eDRL is no longer with your company.
Labelers and manufacturers will need to double check their Establishment Registration status to make sure that all establishments referenced in their drug product listings are properly registered, at least through the end of the year.
It is worth noting that these requirements currently apply only to products regulated by CDER or CBER. CVM has not yet provided information on how it plans to implement this aspect of the Final Rule for animal health products.
Please note, if your organization has received a deficiency letter from FDA regarding any of the NDCs currently listed under your labeler code, you will not be able to certify those products. Labelers should contact eDRLS@fda.hhs.gov to resolve this issue.
What Happens If You Do Not Recertify?
In order to ensure that their listings remain active in the FDA NDC Directory next year, labelers must submit a No Changes Certification between October 1 and December 31. Organizations not meeting this requirement may see their product listings removed from the NDC Directory and other related publications (e.g., NLM DailyMed) on January 1.
Remember, drug products not electronically listed with full and accurate information are considered misbranded and may not be marketed in the United States.
Questions? Need Help?
New requirements and short compliance timelines can be confusing and overwhelming. Fortunately, Reed Tech has you covered. To learn more, register for our upcoming free webinar on eDRL annual reporting periods. Or contact us anytime with questions or to get started on the No Changes process for your company.