FDA Finalizes the Definitions of 'Suspect and Illegitimate' Pharma Products

It took a couple draft guidances, but now, FDA has issued a final guidance in accordance with the provisions of Drug Supply Chain Security Act (DSCSA) to define illegitimate pharma products that are to be quarantined from distribution and reported to FDA. (Even though it is final guidance, FDA allows for comments to be received by the agency; see https://www.regulations.gov/docket/FDA-2018-D-0338.) It might strike the outside observer that “illegitimate product” is a fairly straightforward concept, but the complexity of the US pharma supply chain, reflected in the details of DSCSA, requires a lot of technical description.

FDA says that the final guidance mostly follows a 2021 version of the same guidance. Changes include: “(1) clarifying the definition of ‘diverted’ by revising the examples clarifying that there are other scenarios besides product dispensed to a patient … ; (2) clarifying FDA's expectations for how trading partners should handle unaccounted for product that is not immediately identified as stolen product; (3) expanding on the definition of ‘fraudulent transaction’ to clarify how clerical errors … should be addressed; and (4) clarifying that the definition of ‘unfit for distribution’ in this guidance applies only to the verification provisions of the DSCSA… .”

For pharma trading partners, the ongoing challenge is how to resolve exceptions in the data being reported—on an item level—in DSCSA documentation. Both the GS1 US Healthcare organization, which has provided the pharma industry with mostly agreed-on communication standards, and solution providers of DSCSA software are addressing this need.