FDA Draft Guide on Drug Supply Chain Security

FDA has issued a draft guidance on “Identifying Trading Partners Under the Drug Supply Chain Security Act” that explains requirements for the various types of entities that take part in the distribution of prescription drugs in the U.S. It also helps clarify for industry whether they 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 Act establishes product tracing requirements for certain trading partners in the drug supply chain, including manufacturers, repackagers, wholesale distributors, and dispensers. It also requires that these trading partners must meet applicable requirements for being “authorized trading partners.” And, it requires FDA to issue regulations that establish federal standards for the licensing of wholesale drug distributors and third-party logistics providers. The agency is currently drafting these regulations.