GDP in the US: New FDA Guidance for Industry on Definitions of Suspect Product and Illegitimate Product

Recommendation

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In March 2023, the U.S. Food and Drug Administration (FDA) has published a new guidance entitled "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act". It replaces the draft guidance of the same name.

The new document is primarily intended to assist trading partners in meeting verification obligations (including notification). It can be seen as part of the FDA's implementation of the Drug Supply Chain Security Act (DSCSA).

Background

The DSCSA was enacted in 2013. It outlines steps to achieve electronic tracing of products at the package level to identify and trace certain prescription drugs. The DSCSA also directs the FDA to establish national licensure standards for wholesale distributors and third-party logistics providers.

Content of the New Guidance

The 7-page document "is intended to help industry identify suspect and illegitimate product in the U.S. pharmaceutical distribution supply chain". It clarifies the agency's interpretation of specific terms used in the definitions of "suspect product" and "illegitimate product". In the document, it is pointed out that "trading partners are required to take specific actions if they identify such products."

The specific terms discussed in the guidance are:

• counterfeit,
• diverted,
• stolen,
• fraudulent transaction,
• and unfit for distribution.

The FDA writes that "although this guidance does not create an exhaustive list of the circumstances that may result in a counterfeit drug, a diverted drug, a stolen drug, a fraudulent transaction, or a drug that is unfit for distribution, it describes the most common scenarios that FDA believes trading partners will encounter."

The guidance document is available as a PDF file for download on the FDA's website. 

Overview of Drug Supply Chain Security Act Law and Policies

Since the DSCSA was enacted in 2013, the FDA has issued a couple of guidance and policy documents - as the overview "Drug Supply Chain Security Act Law and Policies" shows.