New FDA Drug Listing Renewal Requirement

Drug establishments (Domestic and Foreign) must list all drug products marketed in the USA under their labeler code immediately after establishment registration. If there is any change in the drug listing, it must update immediately or before June and December.

FDA Annual drug listing update and blanket submission

If there is no change in drug information for all listed products, establishments can submit a blanket no change certification SPL to FDA, which will consider as all product listings are current and updated. Drug listing update or blanket listing certification must submit every year during the renewal period, which is October 1st to December 31st.

Drug listings that are not updated during the renewal period will be considered inactive. The FDA may remove them from the dailymed website and NDC directory.

LMG can help you with

  • Drug listing with US FDA
  • Annual Drug listing update
  • De-listing of inactive drugs
  • Blanket no change certification

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