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Drug Establishment Registration: What You Need to Know

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Registration Deadline December 31, 2020                                     

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 anything from manufacturing human health prescription drug products to 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.

This registration is required for a variety of products and devices in order to be compliant. These segments include cosmetics, drugs, food products, medical devices, radiation-emitting products, tobacco products, and products related to vaccines, blood, and biologics. Once registered, these products will have an additional element of safety

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 a time-consuming and 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. In fact, depending on the complexity of your submission, certification can be completed in approximately two days and may be more economical than you think! 

With our fast, simple 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 early to avoid the end-of-the-year rush or any unanticipated requests by the FDA. For further details to help ensure you are compliant with 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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