FDA finalises guide on suspect, illegitimate meds

With the implementation deadline for the Drug Supply Chain Security Act (DSCSA) mere months away, the FDA has finalised its guidance on exactly how to define products as counterfeit, diverted, stolen, fraudulent or unfit for distribution.

The new guide – effective immediately – “is intended to help industry identify suspect and illegitimate product in the US pharmaceutical distribution supply chain,” according to the document.

According to the Federal Register, changes in the final version compared to the earlier draft published in 2021 include a clarification of the definition of “diverted” by revising the examples clarifying it is not just product dispensed to a patient that can result in diverted product, noting there are other situations where diversion occurs outside the US pharma supply chain.

It also clarifies the FDA’s expectations for how trading partners should handle unaccounted-for product that is not immediately identified as stolen, noting that situation could arise for example if a trading partner encounters lost or mislaid product. It advises organisations facing these situations to set up internal policies to allow them to determine whether such a product is suspect or illegitimate.

The definition of “fraudulent transaction” has been expanded to clarify how clerical errors or discrepancies in the product tracing information should be addressed, noting that there “may be situations where there is a clerical error or discrepancy in the product tracing information that may not be indicative of a suspect product.”

If the reasons for the error cannot be determined however, the default position is to quarantine the product so not further distribution or dispensing can occur.

Finally, the guidance notes that the definition of “unfit for distribution” applies only to the verification provisions of the DSCSA and to identifying suspect and illegitimate product.”

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