As part of the 2016 Final Rule on Electronic Drug Listing, FDA introduced important new changes that affect all human drug product labelers and manufacturers. Beginning in 2017, every existing human drug product listing must be either 1) updated during the course of the year to reflect changes or 2) certified as current through the submission of a “Blanket No Change Certification” during the annual reporting or “reregistration” period.
Previously, drug product listings could remain untouched indefinitely provided no information within the listing had changed. While drug product companies have always been required to keep product listings updated with the latest labeling, listing data and artwork, many product listings required no maintenance at all for years at a time, as long as there had been no changes to any of the information within.
Now, in addition to submitting updates to any product listings as they occur, drug product companies must submit a Blanket No Change Certification during the annual reregistration period for all remaining products listings, i.e., those that have not changed throughout the year.
Is My Company Affected?
The Final Rule states that this change applies to all drug product listings. However, to our knowledge, only CDER and CBER have made clear provisions to accommodate this change in the rule. Animal health companies with CVM-regulated products should contact CVM for more information.
Our team at Reed Tech has received several questions regarding what this means for manufacturers of dietary supplements. To be clear, the final rule addresses only drug products, which are required to be drug listed using the FDA’s National Drug Code (NDC) numbering system. A dietary supplement should not be drug listed or receive an NDC, but may be numbered with National Health Related Items Code (NHRIC). The Blanket No Change Certification does not apply to these products.
So your company is affected by this change if you have human health products that are drug listed with the FDA under your company’s NDC Labeler Code. However, depending on your company’s role in the process (labeler, contract manufacturer, etc.), you may not have to take any official action. Manufacturers bear the ultimate responsibility to the FDA for properly drug listing products and maintaining the listings throughout their lifecycle. However, labelers can still experience severe consequences if their manufacturers do not meet all requirements. So labelers must work closely with their manufacturers to define functional responsibilities and to ensure all drug listing requirements are met. You can read more about FDA drug listing requirements for manufacturers here.
Please note, listings with a marketing end date in the past do not need to be certified but listings containing a marketing end date in the future do.
What is Being Certified?
It is important to understand that, by submitting a Blanket No Change Certification to the FDA, you are stating to the agency and to any other users of this information that all product listings under the Labeler Code in question are up-to-date in every way. That means all listing data, labeling, artwork, establishment information, etc. should be carefully reviewed prior to the Blanket No Change submission. Any problems you identify should be updated in a revised product listing prior to the Blanket No Change.
Please note, the FDA will not allow a product listing with a known deficiency to be certified under this submission. You should resolve all deficiencies in existing product listings prior to submitting the Blanket No Change.
When Must My Product Listings be Certified?
Blanket No Change Certifications can be submitted only during the reporting period, which runs from October 1 to December 31. All product listings not created or updated in the course of the year must be certified annually during this period.
This means that time is running out for any organization whose product listings have not yet been certified for 2017.
What if I Miss the Deadline?
FDA has stated very clearly that product listings not created, updated or certified in 2017 will be considered expired and removed from the NDC Directory and Unfinished Drug download files. This means the products are considered misbranded and may not be distributed within or imported into the United States.
In addition, if you miss the deadline, you will have to relist each drug product individually, which will be a much more time-intensive (and potentially costly) process.
Where Can I Go for Help?
You can rely on Reed Tech to help. Contact us today for support in meeting the deadline. You can also sign up for a free webinar about the No Change Certification process. But hurry, the reporting period ends December 31!