In a late-March 2018 downloadable report, the Office of Inspector General, U.S. Dept. of Health & Human Services encouraged the FDA “to ensure dispensers understand their responsibilities to receive complete drug product tracing information from trading partners before taking ownership,” noting “FDA concurred with our recommendation.”
OIG interviewed 40 dispensers between Dec. 2016 and Feb. 2017, including different-sized independent, chain, and hospital pharmacies. Twenty-six of them received all required drug product tracing information from their trading partners, while 14 were missing these elements, including two that the report said were “unaware of the DSCSA and requirements for drug product tracing.”
To that point, OIG noted, “Although dispensers are generally implementing these requirements, missing information and a lack of awareness of DSCSA requirements raise concerns that a complete tracing record for a drug product may not always be available to support investigations of suspect and illegitimate drug products in the supply chain.”
OIG’s recommendation for FDA educational outreach would aim to facilitate DSCSA compliance among dispensers. Since more than one year has passed since the survey ended, dispenser compliance could now reveal more positive numbers.