Last month (October 13, 2021), the Food and Drug Administration (FDA) held a conference that is part of the CDER Small Business & Industry Assistance (SBIA) Regulatory Education for Industry (REdI) series.
This meeting aims to offer an Electronic Drug Registration and Listing or the eDRLS system that provides basic instruction in the registration and drug listing policy and process for those who are new to this regulatory program as well as offers regulatory professionals more in-depth information on issues and current events affecting FDA Drug Registration and Listing. It also allows FDA to maintain an updated listing of all drug manufacturers and all drugs manufactured and distributed in the United States. (1)
According to the FDA, owners or operators of establishments that manufacture drugs have to register with FDA. They have to list each drug they manufacture that is intended for commercial distribution and to update the listings twice each year notifying the Administration if this information has changed. This can be done electronically through a structured product labeling or SPL format. (1)
Registration and listing SPL files can be easily created through third-party tools that require an official FDA WebTrader (https://esg.fda.gov/login) account for submission. Each submission, regardless of the source and tools used, passes through a rigorous process. (1)
So, who needs to register with FDA? Any drug establishments that formulate, develop, manufacture, prepare, compound, or process drugs that are marketed in the United States must register with FDA. Foreign companies need to identify a U.S.-based agent and importer or importers when they register. This requirement applies to any bodies that elaborate drugs, but not to most pharmacies, hospitals, clinics, healthcare entities, licensed practitioners, companies that manufacture drugs for research or analysis rather than for sale, manufacturers of inactive ingredients (like colorings, flavorings, preservatives, etc. that might be used as drug components but are not active), and storage facilities. (2)
In addition， medical supplies manufacturers, distributors, and sales organizations that create and distribute drugs have to register within five days of starting to introduce drugs into commercial distribution. They can renew their registration between October 1 and December 31, and this must be done annually, while listing updates can take place at any time. (1-2)
How can you register? You need to create and submit a registration SPL document, created with software that includes all the required information, such as the Data Universal Numbering System (DUNS) number of your establishment or its name and Dun and Bradstreet verification, contact information for the individual who will handle correspondence and communication with FDA, all the applicable business operations that your establishment carries out (e.g., repackaging, relabeling, manufacturing drugs, etc.), and the DUNS of your U.S. agent or importer if applicable. (2)
Even if you are not making changes, you need to renew your registration using one of the available applications and submit a No Change Notification type document. If you need to make changes, you also need to submit through one of the applications the SPL that features all the information about the drug. FDA offers resources to help individuals manage this procedure and training for handling the systems that are in place for an electronic registry. You can also deregister through the application, selecting the document type of Establishment De-Registration. After successful submission, you will receive a renewed expiration date for your establishment within 24 business hours. (2)
Furthermore, you need to include a listing of all the drugs that will be commercially distributed in the U.S. under their labeler code, which is something you must request from the FDA. This needs to feature all the required information for all products featuring active and inactive ingredients, dosage and administration route, 10-digit National Drug Code (NDC),...
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