The FDA (Food and Drug Administration) in the United States is responsible for regulating pharmaceuticals, including the approval and potential delisting (withdrawal) of drugs from the market. Drugs can be delisted for several reasons, including safety concerns, lack of efficacy, or when manufacturers fail to comply with regulatory requirements.
If a company no longer markets the drugs for several reasons, then they must de-list it with marketing end date which is the expiration date of last lot manufactured.
All drug listings must be renewed between October 1st and December 31st every year.
Starting January 1st every year FDA will inactivate human drug listings that are not certified between the renewal period of October 1 to December 31.
In addition to that starting from July 1st every year, FDA will begin to inactivate human drug listings that remain active and certified after the June listing update, if it contains at least one establishment that is not currently registered.
A private label distributor (PLD) or finished drug manufacturer can certify the drug listing at any time during that window, including prior to the renewal of the registration of an underlying manufacturer.
Prior to the listing renewal, manufacturers must renew their registration between October 1st and December 31st each year.
If the manufacturer fails to renew their registration, the listings will be considered misbranded for being manufactured at an unregistered establishment.
In July, the FDA will inactivate those active listings which are still linked to an unregistered establishment.
FDA will send Prior notification to the labeler code contacts for any listing in jeopardy of being inactivated, to allow for an update.
FDA inactivation is not the same as de-listing of the drug. As per FDA regulations, companies must de-list the products when they discontinue manufacturing it for commercial distribution.
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
www.fdahelp.us