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Drug Establishment Registration Reporting Requirements and Timelines


Registration Deadline December 31, 2019                                     

What are Drug Establishment sites?

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).

What are the registration requirements?

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 to the FDA in Structured Product Labeling (SPL) format via the Electronic Submissions Gateway (ESG).

How do I know if I need to register?

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

For those beginning new ventures, it is imperative to know that owners of drug establishments are required to register “within five 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 the FDA on January 1 of the following year.

What are my next steps?

Submitting Structured Product Labeling (SPL) data to the FDA is time-consuming and a rigorous process. For more than 15 years, Reed Tech has provided over 1,000 drug manufacturers and distributors with fast, accurate and cost-effective* solutions to gather, convert and submit SPL data to the FDA.

With our simple and quick three-step process we will manage the whole SPL process for you to update and list your products and register your establishment before the December 31 deadline.

It’s wise to start the process now to avoid the end-of-the-year rush or any unanticipated requests by the FDA. For further details to help ensure you meet these mandatory FDA initiatives, click below…

* Depending on the complexity of your submission, certification can be completed in approximately two days and it may be more economical than you think.

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