The U.S. Food and Drug Administration (FDA) removed 771 drug facilities from its registration database in 2016. There were 10,505 drug facilities in FDA’s database on December 31, 2015. As of February 17, 2016, that number had dropped to 9,734.
The large decrease in registered drug facilities is likely due to facilities failing to complete their annual registration renewal. FDA requires drug facilities to renew existing registrations each year between October 1 and December 31. When completing a registration renewal, facilities must list any drugs not listed the year before. Renewals must be completed electronically unless FDA has granted a waiver.
The drop in registered drug facilities in 2016 was less than the drop in 2015. In 2016, FDA removed about 7% of registered facilities. In January 2015, FDA removed 14% of registered drug facilities from its 2014 database. Contact Registrar Corp for country-specific data or for additional details on the drop in registered drug facilities.
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 renewed its FDA drug establishment registration for 2016 should do so before continuing distribution.
Registrar Corp assists drug facilities with FDA compliance and can help facilities register and list their products with FDA. For more information on FDA registration requirements or other FDA regulations for the drug industry, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.