FDA finalizes guidance on suspect products under DSCSA

The US Food and Administrations (FDA) on Thursday finalized guidance defining what constitutes suspect and illegitimate products, as well as what constitutes products that are counterfeit, diverted, stolen, fraudulent or unfit for distribution.

The guideline aims to help industry meet their verification obligations under the Drug Supply Chain Security Act (DSCSA) which requires trading partners to be able to identify a suspect or illegitimate product. The guidance sets out the agency’s interpretation of the terms “counterfeit,” “diverted,” “stolen,” “fraudulent transaction” and “unfit for distribution,” which are not defined by DSCSA.

It replaces the draft guidance issued on 4 June 2021. (RELATED: FDA details plans for DSCSA implementation in four guidances, Regulatory Focus 4 June 2021)

Among the changes from the draft guidance is a clarification that the definition of diverted can include other scenarios besides products being dispensed to a patient. The former version defined diverted to “include product that is dispensed to a consumer or patient and then reintroduced into the U.S. pharmaceutical distribution supply chain to a trading partner.” The final guidance adds language stating that there could be other situations involving diversion of products that are “otherwise removed from the U.S. pharmaceutical distribution supply chain.”

The guidance also clarifies FDA’s expectations for handling unaccounted for products that are not deemed stolen. The revision adds new text stating that trading partners “may encounter a situation involving lost or missing product.” FDA said in these situations, companies should consult their own internal policies “to look into the circumstances surrounding the lost or missing product to determine whether it has been stolen or is otherwise suspect or illegitimate product.”

Additionally, the guidance expands the definition of ‘‘fraudulent transaction’’ to address clerical errors or discrepancies in product tracing information. The guidance states that “it may not be immediately evident whether product tracing information is knowingly falsified. 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. In such circumstances, FDA recommends that a trading partner take steps to determine whether the error can be resolved and whether the product is suspect or illegitimate.”

Editorial changes were also made to improve clarity.

Final guidance

FDA finalizes guidance on suspect products under DSCSA

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