FDA Drug Listing Renewal Readiness Checklist

FDA drug listing and registration renewal season runs from October 1 through December 31. Use this checklist to begin reviewing your FDA records before the renewal window becomes a year-end priority.

1. Establishment Registration Information

Confirm that establishment information remains accurate, including facility details, ownership information, official contact information, and U.S. agent information where applicable.

2. Active Drug Listings

Review active drug listings to confirm that listed products are still marketed and that product information remains current.

3. NDC Records

Check NDC records for accuracy, including labeler code, product code, package code, product description, and related listing information.

4. SPL Submissions

Review Structured Product Labeling submissions to determine whether updates are needed based on product, labeling, manufacturer, or marketing changes.

5. Marketed Product Information

Confirm that product marketing status, packaging, labeling, and distribution details align with current commercial activity.

6. Annual Certification

For eligible listings where no changes have occurred, annual certification may apply during the renewal period. Listings that were updated during the current calendar year may not require the same certification activity.

PCC Support

Pharma Compliance Consultants supports companies with establishment registration renewal, drug listing updates, annual certification, NDC review, SPL submission support, and ongoing listing maintenance.

Contact PCC to discuss your FDA renewal readiness needs.