The DSCSA requires wholesale distributors (WD) and third-party logistics providers (3PL) to report licensure and other information to the FDA annually. This reporting is through FDA’s CDER Direct Electronic Submissions Portal. The registration began November 27, 2014 for the 3PLs and January 1, 2015 for the WDs. Since then, the FDA has collected thousands of registrations and turned the registration information into an impressive database of WDs and 3PLs. At the date of this blog, the database contained 16,794 facilities, including 15,574 WDs and 1220 3PLs.
The DSCSA requires all parties in the drug supply chain to only do business with authorized trading partners (ATP). This database enables companies to streamline the process of identifying authorized trading partners. Instead of confirming with each trading partner, companies can now inquire through the FDA reporting database. The FDA provides a search function for such inquiries on the FDA website, in addition to a download file, updated daily and made available to the public. Dr. Connie Jung, Acting Associate Director for Policy and Communications, Office of Drug Security, Integrity & Recalls, encourages the registrants to search and verify their own information using either the web search or the download file. If you find an error on your registration information, you need to send an email to the FDA to request a correction.