Without Much Fanfare, FDA Creates System for DSCSA Licensure Reporting

December 2, 2014

By Andrew J. Hull* & William T. Koustas 

Last week, FDA announced its long-awaited draft guidance to establish standards for the interoperable exchange of information as required by the Drug Supply Chain Security Act (“DSCSA”) (see our previous post here). On November 26th, FDA also released a website database to implement the DSCSA requirement that wholesale distributors and third-party logistic providers (“3LPs”) report their licensing information to FDA on an annual basis. While there has been some uncertainty among wholesale distributors and 3PLs regarding compliance with these provisions of the DSCSA, FDA’s launch of this new database, while timely, was, to our knowledge, made without much notice. However, unlike the release of the recent guidance document, we were not surprised this database was created last week as an FDA official expressed confidence that the database would be ready by the DSCSA deadline (see our previous post here).

This new database requires wholesale distributors and 3PLs to create an account with the FDA portal in order to report their licensing information. Additionally, the FDA website reminds industry that, under the DSCSA, 3PLs are required to begin reporting on November 27, 2014, and wholesale distributors are required to begin reporting on January 1, 2015.

*Admitted only in Virginia. Work supervised by the Firm while D.C. application pending.