The Food and Drug Administration (FDA) is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supplychain in accordance with the Drug Supply Chain Security Act (DSCSA).
This guidance revises the Agency’s draft guidance for industry Identifying Trading Partners Under the Drug Supply Chain Security Act (August 2017) to address the status of some entities as trading partners (e.g., private-label distributors, salvagers, and returns processors and reverse logistics providers), provide clarification on certain drug distribution scenarios, and address the interpretation of section 582(a)(7) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which discusses third-party logistics providers (3PL) licensure status prior to the effective date of the forthcoming regulations establishing licensure standards.
The DSCSA establishes product tracing requirements for certain trading partners in the drug supply chain, including manufacturers, repackagers, wholesale distributors, and dispensers.
The DSCSA also requires that trading partners of manufacturers, wholesale distributors, dispensers, and repackagers must meet the applicable requirements for being authorized trading partners.
Additionally, the DSCSA requires FDA to issue regulations that establish Federal standards for the licensing of wholesale drug distributors (WDDs) and 3PLs.
The Agency is currently drafting these regulations. This guidance, when finalized, will explain FDA’s current thinking on how certain DSCSA requirements apply to entities that are considered trading partners in the drug supply chain.
This guidance is intended to:
(1) assist industry and State and local governments in understanding the applicability of DSCSA requirements to the various types of entities that take part in the distribution of prescription drugs in the United States;
(2) help 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 guidance does not address all requirements described in the DSCSA but is limited to describing the activities that would determine what type of trading partner an entity may be and the applicable requirements under the DSCSA.
