FDA Drug Establishment Registration Renewal

Domestic and foreign Drug Establishments registered with US FDA must renew their registration every year between October 1st and December 31st. The renewal must submit in SPL format with the same set-id used in the original establishment registration SPL via FDA ESG. The establishment registration is valid till December 31st of next year. FDA Registration number or the facility identifier will remain the same after the renewal. The drug manufacturer must have at least one drug listing with FDA to keep their Establishment registration and NDC Labeler code active. If the establishment does not renew its registration before December 31st, FDA may consider its drug products as misbranded and may take regulatory action; foreign manufacturers’ products may detain at the port.

Cosmetic companies that manufacture OTC Drug products like Acne cream, Sunscreen, Anti-bacterial hand sanitizer, etc... also need to renew their registration every year. If your drug is not marketing in the USA anymore and wishes to cancel the existing registration, you need to submit an Establishment De-Registration SPL to FDA.

FDA will not issue any certificate after registration renewal, but you can verify / Search your drug establishment registration status at the FDA website. FDA establishment registration

If you need assistance in FDA establishment registration renewal, please complete the Establishment Registration Form

FDA Drug Listing Renewal

If there are any changes in the existing drug listing, the labeler must immediately update the drug listing. If there is no change in the drug listing, the labeler needs to submit a no change certification every year during the renewal period, which will consider all drugs reviewed by the labeler and updated. Any drug listing that is not updated between October 1st and December 31st will consider as inactive and removed from the FDA database.

Important

Drug establishments must have at least one drug listing to keep the FDA Drug establishment registration and NDC labeler code active.

New FDA OTC Monograph Drug Establishment Registration Fees 2024

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