Wholesale distributors and third party logistics (3PLs) providers are continuing to affirm their desire to take on more stringent licensing and pedigree requirements in exchange for clarity and uniformity of the expectations across the U.S.
This trade-off had been central to the broad support that the Drug Supply Chain Security Act (DSCSA) drew from these stakeholders, and their continued backing was again clearly voiced at a session on the downstream implementation of DSCSA at a Food and Drug Law Institute (FDLI) conference held in late February at the Washington, D.C. law office of Reed Smith. The conference as a whole was focused on both parts of the 2013 Drug Quality and Security Act (DQSA), including DSCSA (“Title II”) and the Compounding Quality Act (“Title I”).
A panel of distributor and 3PL experts discussed the challenges involved in interpreting and complying with the supply chain licensing and pedigree requirements they face both at the federal and state levels, how the challenges compare for the two types of businesses, and how their respective situations have been impacted by DSCSA.
Strongly reaffirmed was their common support for a comprehensive licensing and pedigree system that is effective, transparent, coherent and efficient, as targeted by DSCSA. Also clear was their concern that the goal has not yet been reached, and that they continue to face a disjointed and resource-draining patchwork of state licensing expectations.
In the effort to verify and secure the distribution of prescription drugs throughout the supply chain, DSCSA requires all distributors and logistics providers to be appropriately licensed by federal and/or state licensing agencies.