Supply chains are complicated, particularly when they involve brokers, wholesale distributors and repackagers. While the DSCSA establishes tracing requirements for various entities, there is confusion in the industry over which partners count as what entities under the law.
FDA’s new draft guidance document, “Identifying Trading Partners Under the Drug Supply Chain Security Act” may clear up some of that confusion once finalized by explaining requirements to the various entities and “help clarify for industry whetherthey are engaged in activities that require licensure and annual reporting, as well as other requirements related to being an authorized trading partner in the drug supply chain.”
The draft guidance includes sections that discuss the following as trading partners under the DSCSA: manufacturers, repackagers, wholesale drug distributors (WDDs), 3PLs and dispensers, with subsections for partners such as brokers and common carriers.
