New FDA Drug Listing Renewal Requirement

Drug establishments (Domestic and Foreign) must list all drug products marketed in the USA under their own labeler code immediately after establishment registration. if there any change in 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. Listing update or blanket certification must submit every year during renewal period which is October 1st to December 31st.

Drug listings which are not updated during renewal period will consider as inactive and FDA may remove from 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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