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Form Approved: OMB No. 09100045. Expiration Date: December 31, 2007. See OMB Statement on Reverse. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION REGISTRATION OF DRUG ESTABLISHMENT/
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Registration of drug establishment is the process of officially registering a facility that manufactures, processes, packs, or holds drugs.
Any facility that is engaged in the manufacturing, processing, packing, or holding of drugs for commercial distribution in the United States is required to file registration of drug establishment.
Registration of drug establishment can be filled out electronically through the FDA's online registration system or by submitting a paper form FDA 2656.
The purpose of registration of drug establishment is to provide the FDA with information about the location and activities of drug establishments to ensure compliance with regulations and to help protect public health.
Information such as the name and address of the establishment, the types of activities conducted at the establishment, the types of drugs manufactured or processed, and contact information for the responsible individual must be reported on registration of drug establishment.
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