Authored by Innovative Science Solutions, now part of Lumanity

The FDA has made available the proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers, which is required by the Drug Supply Chain Security Act (DSCSA). State license regulations vary across state borders, creating confusion among applicants. The new proposed rule will provide uniformity and clarity for wholesale distributors and third-party logistics (3PLs) providers working on state license applications. It will also minimize any proposed risks to the supply chain from any unregulated products.

Wholesale distributors and 3PLs may want to work with a team experienced in state licensure for prescription products, over-the-counter products, medical devices, as well as direct-to-consumer products. Our experts are skilled in the nuances between different state regulations and can help you through the application process to be compliant with the state regulations and the new proposed federal regulation.