DRUG DE-LISTINGS
All drug manufacturers must de-list the drugs with marketing end date from FDA NDC drug code directory if they no longer market the drug for commercial distribution.
Regulatory Requirements
- As per 21 CFR 2027, manufacturers or
registrants must de-list the drug when they are not going to market it in the
United States.
- Registrants must notify FDA if there are any de-listings every June and December.
- Registrants must submit the de-listings with marketing end date which is date of last lot manufacture.
De-listing vs. Inactivation
The key difference between de-listing and Inactivation is as follows.
- De-listing: It is action taken by the
company to notify FDA that the drug is no longer be marketed in the United
States.
- Inactivation: It is the action taken by FDA when the company fails to renew the establishment registration and drug listing between yearly renewal period October 1st and December 31st every year. FDA will remove all the drugs listings from its database and the drugs sold after that will be considered as misbranded.
Databases to track down withdrawn drugs.
- Withdrawn or Removed list: Drugs which
are unsafe or not effective will be removed and these drugs cannot be used by
compounders.
- Orange Book: This is database of approved drugs, drugs whose safety or efficacy approval has been withdrawn are excluded from this list.
- NDC Directory: It is a database to find the status of a drug with its NDC number.
Implications of inactivation
- Drugs will be considered as misbranded
and cannot be legally marketed.
- Selling misbranded drugs can lead to FDA warning letters, product discontinuation, and penalties.
- For foreign manufacturers, FDA will put them on import alert and detain the drugs at the border.
- Insurance will decline the claims if there is no valid NDC number which can lead to loss of reimbursement.
To rectify this, manufacturers can reactivate the drug listings by resubmitting SPL files with correct establishment registration information.
Liberty Management Group provides assistance with drug establishment registration, drug listing and drug listing renewals, and de-listings.
Sudha S
Regulatory Consultant
Email: office@libertymanagement.us