FDA Inactivating Drug Listing Records

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Last month the Food and Drug Administration (FDA) announced its intention to inactivate drug listings for drugs intended for human use that are improperly listed. Reasons that a listing may be considered incomplete and therefore be inactivated include:

  • absence of an annual certification
  • missing identification of a manufacturing establishment

Drug listings not in accordance with FDA requirements are not certified as being active and up to date by the sponsor, or are associated with a manufacturing establishment that is not currently registered with FDA and therefore may be inactivated effective September 13, 2019.  

Organizations are required to submit drug listing updates if any material changes are made to information previously submitted, such as a change in manufacturing establishments. Regulations concerning drug establishment registration and drug listing require organizations/registrants to notify the FDA if commercial distribution of a listed drug is discontinued. 

Oftentimes, drug listings go an extended period of time without being updated. Other possible reasons drug listings are not certified as being up to date are because they identify within the listing information with at least one manufacturing establishment that is not currently registered with FDA. Aside from accidental omission, sometimes drugs are no longer in commercial distribution, and thus should be inactivated. 

Check Your Status

You can check the status of your drug listing via the FDA NDC link here.

Check the status of your establishment registration via the FDA current registration site link here.

Questions?

Contact Synchrogenix, A Certara Company with any regulatory submission questions or needs. Synchrogenix can help make sure you are meeting your obligations for drug listings and help to verify if they are appropriately updated, certified, or associated with a registered establishment.

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Author: Rob Labriola

Rob Labriola has 20 plus years experience in regulatory operations for the pharmaceutical industry. Mr. Labriola has seen it all and truly understands the frustrations and rewards of moving to eCTD. He has worked on multiple application types (INDs, NDAs, BLAs, CTAs, NDSs, JNDAs and MAAs), and has extensive international experience, having submitted applications to the FDA, Canada, Europe, Switzerland, Australia, Israel, Japan, etc.

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