The U.S. Food and Drug Administration (FDA) requires all drug facilities that manufacture, prepare, propagate, compound, or process drugs for commercial distribution in the United States to renew their registrations every year between October 1 and December 31. According to FDA’s Drug Establishments Current Registration Site, there were 10,383 drug facilities listed in FDA’s drug registration database as of December 31, 2014. Of those companies, 1,482 (approximately 14% of the registered drug companies) had not completed their required annual registration for fiscal year (FY) 2015
FDA considers drugs that are manufactured in an unregistered facility to be misbranded. Distributing misbranded drugs in the United States is a prohibited act that can lead to civil or criminal charges. Any drug facility that has not yet registered with FDA for FY 2015 should do so before continuing distribution.
For those companies that have not yet renewed, Registrar Corp can assist. Registrar Corp is an FDA compliance firm that helps drug companies with registration and other U.S. FDA regulations. Contact Registrar Corp at +1-757-224-0177 or through the 24 hour online live help service.