FDA Releases Guidance Documents on Drug Supply Chain Security Act
FDA released four guidance documents June 3 detailing responsibilities under the Drug Supply Chain Security Act for pharmaceutical manufacturers, repackagers and other “trading partners” under the 2013 law. Two final guidances provide more detail on how trading partners should identify suspect products and notify others in the support chain, as well as on product identifiers required on packaging under DSCSA.
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FDA’s final guidance on identification and notification of suspect products does not apply to third-party logistics providers, though FDA encourages 3PLs to follow the recommendations in this guidance to the extent relevant to the 3PL’s operations.” The guidance of product identifiers “is intended to clarify FDA’s interpretation of” the requirements, “including as they relate to the linear barcode requirements.”
The other two guidances released by FDA were drafts. One relates to FDA’s interpretation of the terms suspect product and illegitimate product for verification obligations under DSCSA, revising an earlier draft guidance issued in 2018, including by adding “FDA’s current understanding of the term stolen.”
The other draft guidance clarifies enhanced system requirements under DSCSA that are set for implementation in 2023. The guidance “outlines and provides recommendations on the system attributes necessary for enabling the secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation, as necessary,” FDA said. It also “describes recommendations for the system attributes necessary for enhanced product tracing and enhanced verification, including when the use of aggregation and inference may be appropriate.”