FDA OTC drug establishment registration is the process through which drug manufacturers, repackers, or relabelers notify the FDA of their involvement in producing OTC drug products. Registration is mandatory for every establishment that manufactures or processes OTC drugs sold in the U.S. This ensures the FDA can monitor facilities for compliance with safety, quality, and labeling reg... https://fdalisting.com/page/161/fda-otc-drug-establishment-registration-and-otc-drug-listing/