The FDA confirmed the extension of the saleable returns verification requirements deadline to November 27, 2023. One of the reasons for this latest extension is due to the industry wanting more time to test verification systems using real-time volumes of saleable returned products. The COVID-19 pandemic has also hampered efforts to comply with the saleable returns requirements.
The Drug Supply Chain Security Act requires compliance with the verification of serialized unique identifiers of returned products before resale. However, according to a Federal Register notice, the FDA was notified of challenges faced by stakeholders in developing “interoperable, electronic systems to enable such verification and achieve interoperability between networks.” Initially, the regulations were to be put into effect in November 2019.
This new decision is crucial to avoid a potential shortage of drugs. Because, in the case, if the industry is unable to comply with saleable returns verification requirements set by the DSCSA, good medicines will be quarantined or destroyed. Each year, in the US alone, there are about 60 million saleable returns of drugs worth $11 billion.
The decision was welcomed by the Healthcare Distribution Alliance (HDA), which represents primary pharmaceutical distributors in the US. According to the FDA, despite the delay, the industry will have to adhere to requirements, and there will still be legal liabilities. The FDA expects the pharma sector to act in good faith to move towards compliance.