In addition to establishing a national, interoperable traceability system, the DSCSA also seeks to secure the drug supply chain by establishing uniform standards for licensure of wholesale distributors and third-party logistics providers. The Act sets out general topics to be addressed in federal standards, such as facility inspections, document maintenance, bond requirements, and classes of individuals prohibited from managing facilities, but the FDA is left to establish specific standards through regulation. States that choose to license wholesale distributors and third-party logistics providers must utilize these federal standards. If a state does not operate such a licensing program, a federal license will be available to wholesale distributors and third-party logistics providers in those states.
The Act requires the FDA to issue the necessary regulations no later than November 27, 2015. However, the regulations establishing wholesale distributor licensing standards will not be effective until two years after the final regulations are published; the regulations establishing third-party logistics provider licensing standards will not be effective until one year after the final regulations are published. At this time it appears unlikely that the proposed regulations will be published on schedule.
The DSCSA also seeks to simplify the process of determining whether a wholesale distributor or third-party logistics provider is licensed. Specifically, wholesale distributors and third-party logistics providers must report their licensing information to FDA on an annual basis. That information is then made available by FDA through a public database [link]. FDA published guidance on the reporting obligation in December 2014. PDSA’s comments in response to that guidance are available here.
Preemption is also a very critical issue with regard to licensing.