Drug Establishment Registration

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States must register with the FDA. Domestic and foreign drug manufacturers, repackers, or re-labelers are also required to list all of their commercially marketed drug products. Drug products that are not correctly listed as required are misbranded and may be subject to regulatory action.

Foreign establishments that manufacture, repack, or re-label drug products and import or offer to import drug products to the United States must register with the FDA and identify a U.S. agent. All drugs imported into the United States must be listed by the foreign firm or its designated U.S. agent.

Drug establishment registration and drug listing information have, until now, been submitted using a paper-based format, i.e., Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments' Report of Private Label distributors). Changes in the Act, resulting from the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) (FDAAA), require that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted.

New FDA OTC Monograph Drug Facility Fees 2024

LMG can assist you with

• Drug Establishment Registration
• Drug Listing
• US Agent requirement

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