Back to: Electronic Drug Registration and Listing (eDRLS) Using CDER Direct
Topics Covered
- CDER Direct Establishment Registration Demo
- Establishment Registration Highlights
- Complying with Establishment Registration
Requirements
Presenters
Regie Samuel
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)
Jose Cabrera
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)
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 offer a comprehensive guide to drug establishment registration requirements and compliance. They meticulously detail who must register, which includes any establishment that manufactures, repackages, or relabels drugs for U.S. distribution, explicitly stating that private label distributors should not register. Domestic establishments must register within five calendar days of starting manufacturing, while foreign establishments must do so prior to importing products into the U.S. Annual renewal is mandated between October 1 and December 31, and all changes to establishment information, such as name, address, contact details, or business operations, require submission within 30 days. The sessions provide practical demonstrations of using the FDA Direct (formerly CDER Direct) portal for initial registrations, renewals, and deregistration, emphasizing the convenience of managing multiple establishments under a single ownership within one submission and the paramount importance of accurate DUNS information aligning precisely with Dun & Bradstreet records. Foreign establishments are also required to designate a U.S. agent who maintains a physical presence in the U.S. and to provide importer information. Highlighting the regulatory significance, the presentations underscore the necessity of listing all business operations (e.g., packing, relabeling) as this data is crucial for inspection planning, assessing statutory fees, and drug volume reporting. The FDA actively manages a compliance program that reviews data for inaccuracies, issuing deficiency letters and, if issues remain unaddressed, may inactivate registrations or issue warning letters. Non-compliance carries severe ramifications, including product detention, refusal of entry at U.S. ports, and potential misbranding charges, thereby underscoring the critical role of accurate and timely registration data in safeguarding public health and ensuring regulatory oversight.