Drug listing is an important regulatory requirement that helps the FDA track and monitor all drugs, including over the counter (OTC) drugs, prescription drugs, and other pharmaceutical products marketed in the United States. Drug listing renewals ensure that the FDA has accurate and up-to-date information about each drug product.
Here are the key points regarding FDA drug listing renewal:
- Annual Renewal: Drug listing information must be updated with the FDA annually. The renewal must be completed between October 1st and December 31st of each year for the following year .
- Electronic Submission: Drug listing renewal must be completed electronically through the FDA’s Electronic Submissions Gateway (ESG) or CDER direct.
- Information Updates: During the renewal process, drug manufacturers or sponsors are required to review and update the information related to their drug products, which includes information such as product formulation, labeling, manufacturer information, and establishment registration.
- Consequences of Non-Renewal: Failure to renew drug listings can have serious regulatory consequences. Any drug listing that is required to be certified but is not certified may be considered inactive and removed from the NDC Directory and other publications of listing data.
- NDC Assignment: The National Drug Code (NDC) is an essential part of drug listing. Manufacturers should ensure that the NDCs for their drug products are accurate and up to date while renewing their listings.
Liberty Management Group Ltd, provides assistance with drugs establishment registration, NDC labeler code request, Drug listing renewals and US agent service to foreign facilities.
Sudha S
Regulatory Consultant
Email : Office@libertymanagement.us