FDA Drug Listing & Registration Renewal Season

FDA drug listing and registration renewal season begins October 1, 2026 and runs through December 31, 2026.

During this annual period, drug establishments should renew their FDA registration and review active drug listings to confirm that NDC records, SPL submissions, and marketed product information remain accurate and current.

Pharma Compliance Consultants (PCC) supports companies through the renewal process with practical regulatory assistance, including drug establishment registration renewal, drug listing updates, annual certification, NDC review, SPL submission support, and listing maintenance.

Drug Listing White Paper Available

Companies preparing for renewal season can review PCC’s white paper on FDA drug listing requirements, including NDC review, SPL submissions, annual certification, and ongoing listing maintenance.

Read the white paper here: Understanding Drug Listings and the FDA: A Comprehensive Guide

Cosmetic Registration Support

PCC also assists with cosmetic facility registration and product listing requirements under MoCRA. Cosmetic facility renewals are based on the original registration date, and cosmetic product listings require ongoing maintenance and annual updates.

Prepare Early

October is the right time to review FDA records, correct outdated information, and prepare accurate submissions before the December 31 deadline.

Contact PCC for support with FDA drug listing, establishment registration renewal, SPL submissions, NDC review, or cosmetic registration requirements.