Drug Establishment Registration Reporting Requirements and Timelines

October 7, 2016 Dan Henrich

Drug establishment sites are any facilities which “manufacture, prepare, propagate, compound or process” drug products for commercial distribution or import into the United States. These include sites engaging in the manufacture of human health prescription drug products to those relabeling cosmetics with sunscreen properties (and lots of products in-between).

An establishment registration contains several data fields containing information about the site(s) belonging to a company. These include the company name, location and contact information, D-U-N-S® Numbers and business operations for each site, as well as U.S. Agent and importer information for sites located outside the U.S.

Every electronic drug establishment registration must be renewed or updated annually between October 1 and December 31, regardless of whether there have been changes to the data or whether a submission has been made earlier in the year. Registrations expire at the end of the following year.

Registrations must be submitted in Structured Product Labeling (SPL) format via the Electronic Submissions Gateway (ESG).

To check and see whether a particular drug establishment site is currently registered, you can visit FDA’s Drug Establishment Current Registration Site (DECRS) and search by name.

For those beginning new ventures, it is important to know that owners of drug establishments are required to register “within 5 days of beginning operations.” However, if you register your establishment outside of the annual reporting period, you still must make a submission between October 1 and the end of the year. Otherwise, your site will not be actively registered with FDA on January 1 of the following year.

If you need help immediately with your company’s establishment registration, contact Reed Tech. One of our team members will be happy to help you clear this hurdle.

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