FDA Issues Draft Guidance on Drug Supply Chain Security

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 08-22-2017 14:16


The US Food and Drug Administration has issued draft guidance, Identifying Trading Partners Under the Drug Supply Chain Security Act , to help industry and state and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). The DSCSA was signed into law in November 2013 and outlined steps to build an electronic, interoperable system by 2023 that will identify and trace prescription drugs that are distributed within the US. Its purpose is to reduce diversion of drugs distributed domestically as well as help reduce the influx of counterfeit drugs from foreign sources.

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.” The DSCSA also requires FDA to issue regulations that establish federal standards for the licensing of wholesale drug distributors and third-party logistics providers. The FDA is currently drafting these regulations. This guidance, when finalized, will explain FDA’s current thinking on how licensing and certain other requirements apply to entities that may be considered trading partners in the drug supply chain.

The draft guidance is intended to: (1) assist industry and state and local governments in understanding the applicability of DSCSA requirements to the various types of entities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 US and (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.

Source: US Food and Drug Administration


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