On January 2, 2018, the U.S. Food and Drug Administration (FDA) removed all drug establishments that did not renew their FDA registrations for 2018 from its active registration database. The Agency also removed all uncertified drug product listings from publication.
- FDA removed 1,256 of the 10,496 drug establishments in FDA’s database as of December 31, 2017 (12%)
- FDA removed 30,786 of the 118,255 drugs listed in FDA’s database as of December 31, 2017 (26%)
REGISTRAR CORP can verify that drug establishment registrations and drug product listings are active at no cost
Annual FDA Drug Establishment Registration
FDA requires registered drug establishments to renew their registrations between October 1 and December 31 each year. Those that fail to renew by the deadline are removed from FDA’s database, and drugs manufactured in unregistered facilities are considered misbranded. Marketing misbranded drugs in the USA is a prohibited act that may be met with seizure and injunction.
New “Blanket No Change Certification” Requirements for Drug Product Listings
FDA requires drug establishments to report any changes to product listings in June and December each year. Until recently, unchanged listings required no action. FDA introduced a change for the 2017 renewal period requiring registered drug establishments to submit a “blanket no change certification” in structured product labeling (SPL) format for all drug listings that required no updates within the year. Unchanged listings that were not properly certified during the 2017 renewal period were removed from publication, making it a prohibited act for those products to be marketed in the USA.
Registrar Corp can verify whether your listings are currently on file with FDA at no cost.
EXPORT ACCESS is the Authorized Agent for UK & Ireland for REGISTRAR CORP, USA – the leading global provider of compliance services for goods entering the USA which are subject to regulation by the US Food & Drug Administration (FDA). Registrar Corp assists with FDA registration, drug product listings, drug labeling, drug master files (DMFs), and more.
Image courtesy of FDA web site.