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FDA announced changes to the timing of annual registration of facilities on its Drug Establishments Current Registration Site (DECRS). Facilities that manufacture, prepare, propagate, compound or process drugs that are commercially distributed in the U.S. or offered for import to the U.S. are required to register. Establishments must be registered within 5 days of beginning operations and must renew registration annually between October 1st and December 31st of each year. If a firm submits its initial, updated or annual registration outside this time frame, it is considered registered only until the end of the current year. Additional points of contact for questions regarding registration and guidance for industry can be found here.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
