FDA Removes Expired Drug Establishment Registrations and Uncertified Listings from its Database

Registrar Corp reports on data revealing that FDA removed 12% of drug establishments and 26% of drug product listings that were not properly renewed or certified for 2018.

HAMPTON, Va.Jan. 8, 2018 /PRNewswire/ — 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%)

Companies that would like to verify that their drug establishment registrations or drug product listings are active with FDA can do so at no cost using the following links:

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. 

Registrar Corp can verify whether your registration was properly renewed at no cost. Verify your registration now.

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.  Verify your listings now. 

Registrar Corp is a U.S. FDA consulting firm that helps drug establishments comply with FDA regulations.  Registrar Corp assists with FDA registration, drug product listings, drug labeling, drug master files (DMFs), and more.  For questions or assistance, visit www.registrarcorp.com, call +1 757 224 0177, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

David Lennarz
Tel: +1 757 224 0177
Email: 188318@email4pr.com


Nice Insight

Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.

Registrar Corp

Registrar Corp was founded in 2003 to help businesses comply with U.S. Food and Drug Administration (FDA) regulations. Since opening its headquarters in Hampton, Virginia, USA, Registrar Corp has expanded to eighteen international offices and has aided more than 30,000 companies across 160 countries. Employees include former U.S. FDA officials, scientists, and industry experts.