You may have seen one of our recent posts about the FDA’s new Blanket No Change Certification submission requirement for drug products. If not, you can get a quick rundown of the requirements here.
To help track compliance with the new requirements, FDA has added a field to its downloadable NDC Database File showing the date through which a product has been certified (located in Column T, called “LISTING_RECORD_CERTIFIED_THROUGH”). Products that were updated during 2017 or certified as containing no changes should indicate that they are certified through 2018.
The Reed Tech team took a look at this report and noticed that a quarter of the nearly 120,000 Product IDs in the report expired at the end of 2017. A review of the Unfinished Drugs report showed an even higher percentage of expired listings.
How Do I Tell if There’s a Problem With My Products?
To see if any of the affected products belong to your company (or one your company does business with), take one of the two steps below.
To look up a single NDC, search the NDC Directory. You will notice (for any uncertified products) a red (U) appears next to the Proprietary Name and all other values have been redacted except for “NDC Package Code” and “Labeler Name.”
Source: FDA NDC Directory
You can also download the database file mentioned above and sort by labeler name or NDC product code, then look at the certified through date. “20171231” indicates a record that was not certified before the deadline and is now uncertified.
It’s important to know that, while your product may still appear on the NLM DailyMed site, that does not mean it’s properly drug listed. Always reference the FDA NDC Directory for the latest drug listing information.
What Happens if a Product is Uncertified?
If a drug product listing was not updated or certified in 2017 as containing no changes to the information on file, it has now been flagged in the NDC Directory as an uncertified product. As FDA stated prior to the deadline, uncertified products are not properly drug listed. Since improper drug listing constitutes misbranding, this means these products cannot be marketed or sold in the United States until this has been addressed. This may also affect reimbursement from federal programs, including Medicare and Medicaid.
Help! How Do I Fix This?
You cannot simply submit a Blanket No Change Certification now that the deadline has passed. To ensure your products are properly listed, you will need to submit a full drug product listing for each uncertified product. Unfortunately, for many industry members, this will be more a time-consuming and costly process than performing the Blanket No Change Certification prior to the deadline. The good news is that, assuming there are no changes in the meantime, you will not need to certify it again in 2018.
If you need help fixing uncertified product listing records, contact Reed Tech today—our team will be happy to help you. Remember, this is an extremely urgent issue that affects your company’s ability to do business in the U.S.! Don’t wait!