Time to Renew: FDA Drug Establishment and Listing Deadline Is Coming Up

If your company manufactures, repacks, relabels, or imports drugs for distribution in the U.S., it’s time to prepare for the FDA drug establishment renewal season. Every year, between October 1 and December 31, the Food and Drug Administration (FDA) requires all registered drug establishments to renew their registration and certify their product listings. 

Missing this deadline can lead to automatic deactivation of your establishment registration or delisting of your National Drug Code (NDC) products from the FDA database. These renewals are essential for maintaining active market authorization and ensuring your products remain compliant with 21 CFR Part 207, which governs drug registration and listing.  

Keep reading to understand what’s required, what happens if you miss the deadline, and how you can make this process easier. 

Understanding the FDA Drug Establishment Renewal 

Each year, establishments must log in to CDER Direct or the Electronic Drug Registration and Listing System (eDRLS) to confirm or update their registration and listing information. 

The FDA requires companies to renew their registration between October 1 and December 31 each year, submit updates if there are changes to products, ownership, or operations, and file a “No Change Certification” if there are no updates to existing listings.  

If an establishment fails to renew or update by December 31, 2025, the FDA will automatically deactivate its registration and remove all listed products from the NDC directory. 

Why This Deadline Matters 

Failing to meet the renewal requirement could interrupt your ability to manufacture or distribute drugs legally in the U.S. Once an establishment is delisted, products cannot be marketed until the registration is restored, a process that can delay operations and affect revenue. 

Moreover, your NDC product listings may also be removed from FDA’s NDC Directory, making them appear inactive to retailers, distributors, and consumers. 

Renewing on time keeps your operations compliant and maintains your company’s credibility with clients, regulators, and supply chain partners. 

How to Renew Your FDA Drug Establishment Registration 

The FDA requires all updates and renewals to be submitted electronically through CDER Direct. Here’s a simplified overview of the process: 

1. Access your account in CDER Direct or eDRLS. 
2. Verify establishment details such as name, DUNS number, and address. 
3. Review product listings and update or certify them using the “No Change” option if applicable. 
4. If you are a foreign facility, ensure you have a designated U.S. agent for your license. 
5. Submit your renewal before December 31, 2025. 

It’s a good practice to confirm that your contact and ownership details are current to prevent correspondence issues or accidental deregistration. 

Common Mistakes to Avoid 

Many companies face delays because they: 

• Miss the October 1 – December 31 renewal window. 
• Forget to update discontinued products. 
• Use outdated submission templates. 
• Fail to review ownership or manufacturing changes. 
• Fail to have a U.S. agent for foreign facilities. 

Being proactive and verifying details early helps avoid these pitfalls. 

Key Takeaways 

• Annual FDA drug establishment renewal must be completed by December 31, 2025. 
• Renewals and updates are submitted electronically via CDER Direct or eDRLS. 
• Failing to renew results in automatic deregistration and product delisting. 
• “No Change Certifications” are acceptable if no updates are needed. 
• Staying compliant ensures uninterrupted distribution and FDA recognition.