Back to: Electronic Drug Registration and Listing (eDRLS) Using CDER Direct
Topics Covered
- CDER Direct Labeler Code Request Demo
- Labeler Code Request Highlights
- Complying with Labeler Code Request Requirements
Presenters
Puii Huber
Technical Information Specialist
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration, and Unapproved Drugs
Office of Unapproved Drugs & Labeling Compliance (OUDLC)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Laurie Simonds, GWCPW
Technical Information Specialist
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration, and Unapproved Drugs
Office of Unapproved Drugs & Labeling Compliance (OUDLC)
Center for Drug Evaluation & Research (CDER)
US Food and Drug Administration (FDA)
Vikas Arora, PharmD
Consumer Safety Officer
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration, and Unapproved Drugs
Office of Unapproved Drugs & Labeling Compliance (OUDLC)
Center for Drug Evaluation & Research (CDER)
US Food and Drug Administration (FDA)
Abstract
These virtual conference presentations explain the critical process of managing National Drug Code (NDC) labeler codes, which are assigned by the FDA and identify drug manufacturers or distributors. A labeler code, the first segment of the NDC, is required to list drugs for U.S. commercial distribution and must be requested within five days of product launch. The FDA Direct portal is central to this process, used for initial requests, completing labeler code assignments, and managing updates. Firms must provide accurate and complete information, including name, address, email, business operations, and drug type, as this data is crucial for FDA communication and compliance. Timely updates are essential, with a 30-day deadline for any changes to contact or business details. Labeler codes without listed drug products are automatically inactivated after 24 months following a 30-day notification, and can also be voluntarily inactivated by firms or immediately inactivated by the FDA if obtained falsely or if compliance issues are not resolved. Mergers and acquisitions necessitate careful updates to ensure all related registration, labeler code, and listing data are correct. The FDA maintains a compliance program to ensure data integrity, emphasizing that non-compliance can lead to inactivation, preventing drug listings.