Complying with the Authorized Trading Partner Requirements of the DQSA
Source: The Food and Drug Law Institute
The Drug Quality and Security Act (the DQSA), enacted on November 27, 2013, enhances the security of the pharmaceutical supply chain by establishing a national system for traceability and serialization of certain pharmaceutical products and for establishing national licensing standards for wholesale distributors and third-party logistics providers. While a great deal of attention has been paid to the information-sharing obligations that commence on January 1, 2015, the serialization obligations that begin in 2017, and the federal licensing standards that will be developed and implemented over the next few years, significantly less dialogue has occurred with respect to the small, but equally important, provision that requires all of an industry participant’s trading partners to be “authorized trading partners.”