Back to: Electronic Drug Registration and Listing (eDRLS) Using CDER Direct
Topics Covered
- CDER Direct Drug Listing Demo
- Listing Updates and Blanket No Change Certification
Demo - Drug Listing Highlights
- Complying with Drug Listing Requirements
Presenters
Troy Cu
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)
Yogesh Paruthi, 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)
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)
Tasneem Hussain, PharmD
Pharmacist
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)
Abstract
These virtual conference presentations meticulously outline drug listing requirements and compliance for products in U.S. commercial distribution. Any establishment required to register, including contract manufacturers (CMOs), must list their drug products, while private label distributors (PLDs) are exempt from registration but still need their products listed, often by the CMO or themselves. Initial drug listings are due within three calendar days of initial establishment registration, with updates mandated at least by June and December each year, or sooner for material changes. The FDA Direct portal (formerly CDER Direct) is the primary tool for submitting and managing these listings, which involves providing comprehensive data elements such as NDC, proprietary name, marketing status, ingredients (including inactive), strength (requiring specific numerator/denominator formats), and packaging details. The presentations emphasize the critical importance of accurate and complete data, as inaccuracies can lead to automated validation errors or compliance issues. Firms can also use a Blanket No Change Certification from October 1st to December 31st to certify unchanged listings. Special guidance is provided for combination products, detailing how to identify and list different types. The FDA actively manages a data inactivation process in January (for uncertified listings) and July (for listings linked to unregistered establishments), leading to product removal from public databases like the NDC Directory and potential CMS reimbursement issues. Compliance involves adhering to 21 CFR 207, responding promptly to deficiency letters, and ensuring all data is current and correct to prevent severe consequences of non-compliance and facilitate public health.