The U.S. Food and Drug Administration (FDA) recently removed 1,379 drug facilities from its drug registration database due to non-renewed registrations. FDA requires drug facilities to register annually between October 1 and December 31. FDA’s Drug Establishments Current Registration Site offers a frequently updated, downloadable file which lists the facilities currently in the database. On December 31, 2014, there were 10,383 facilities in FDA’s database. Of those registered drug facilities, 14% had not yet renewed their registrations for fiscal year (FY) 2015. On January 6, 2015, the number of facilities in the database had been reduced to 9,004.
If a facility is not registered with FDA, any drugs it manufactures will be considered misbranded. FDA can take civil or criminal action against a facility that distributes misbranded drugs in the United States, as it is a prohibited act.
Registrar Corp can help drug facilities that were removed from the database by properly registering them with FDA. For assistance with determining whether or not a facility is registered in FDA’s database or to complete a drug facility registration, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day through the Live Help service.