Life Sciences Blog

Don’t Wait! Blanket No Change Product Certifications – Top 6 Process Errors

by | Nov 8, 2018

If you need to submit a Blanket No Change Certification (BNCC) for your drug products this year, be aware that validation procedures are being strongly enforced by the FDA. You may encounter unforeseen errors this year that were not detected last year and need additional time to resolve the issues.

Every active drug listing on file with the FDA that has not been initially listed or updated during the current 2018 calendar year must be certified that no changes have occurred in order to remain active for the coming 2019 year. The drug product listing certification must be submitted via an electronic SPL file to the FDA during the annual October to December timeframe. The certification of an NDC product code is a statement that all product data has been reviewed and deemed accurate and up-to-date.

The scope of this certification is centered on the drug product listings and extends to establishment registrations and labeler codes. The NDCs listed in the certification will be cross-validated against the current drug product listing SPL and the referenced establishments in the product listing SPL. Any error found in the certification cross-check process will cause the complete certification to fail, i.e., none of the listed NDC product codes will be certified.

6 Certification Errors to Avoid

Please review your product listing SPLs closely

  1. The referenced establishment is not registered for 2018 (refer to the DECRS database).
  2. The product was never listed electronically.
  3. The product is currently delisted or is not active, i.e., “excluded” (refer to the DailyMed).
  4. The SPL listing submitted in the past may have met the validation rules at that time, but when checked today against current validation rules it fails, e.g., the Combination Product Type field is missing.
  5. The product has a future marketing date.
  6. The product is referenced in an FDA compliance notification with a deficiency.

And a new twist this year… is the Drug Supply Chain Security Act (DSCSA) that requires a serialization Product Id to appear on Rx drug labels by November 27, 2018. An Rx drug NDC cannot be included in the BNCC if the Principal Display Panel (PDP) image has not been updated to show the Product ID.

Don’t wait to certify product listings. A detailed analysis may be required to identify what is causing the errors. To meet this year’s December 31 deadline, it is wise to start the process now for Blanket No Change Certification. In addition, if it is discovered that an updated listing is required or an FDA manual override is necessary, it is recommended to avoid the end-of-year rush.

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