Life Sciences Blog

Stay Current with FDA Blanket No-Change Certification

by | Oct 1, 2020

The fourth quarter of 2020 is fast approaching along with the Blanket No-Change deadline of December 31st. For drug manufacturers, action needs to be taken to keep product listings active before the calendar turns to 2021.

What drug listings have to be updated? Every active listing on file with the FDA that has not been updated within the current calendar year must be certified to remain active for the coming year. If a listing submission is new or has been updated in the current calendar year, it is considered up-to-date and no additional certification necessary. The annual certification for SPL submission accepted by the FDA begins October 1st and closes December 31, 2020. After this window, individual product listing SPLs must be used to renew or update any listings.

A little background: The Blanket No Change Certification was introduced in 2017 when the FDA published the “Final Labeling Rule”: Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs. This rule requires any organization selling drug products in the US to electronically register the drug products and assign an NDC Code to the product.  Additionally, the products must be certified on an annual basis by updating the product listing or by submitting a Blanket No Change Certification file. If a drug product is still actively marketed and sold without being properly listed, it is now considered “misbranded” and will be removed from publication in the NDC Directory and Unfinished Drug download files.

See the recently recorded webinar discussing the annual Blanket No-Change Certification submission requirements for drug product listings and what is needed to complete the process.

For more information about the Blanket No-Change Certification and avoiding FDA inactivation contact Reed Tech at pharma@reedtech.com.

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