New enforcement date for returns verification: Nov 27, 2023.
In 2019, FDA issued a one-year delay for the enforcement of the Drug Supply Chain Security Act (DSCSA) requirement for wholesaler distributors to verify a product identifier (PI) prior to further distributing returned product.
With the 2020 enforcement date approaching in November, FDA has announced an additional three-year delay, noting, “FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2023, verify the product identifier prior to further distributing returned product as required under the DSCSA… In addition, FDA does not intend to take action against dispensers who do not verify the statutorily-designated portion of product identifiers of suspect or illegitimate product before November 27, 2023. This policy represents a 3-year delay in enforcement of the requirements for dispensers to verify the product identifier when investigating suspect or illegitimate product.”
As has been covered previously, some industry players have been concerned about quarantined product and potential drug shortages if proper systems were not put in place to verify returned product in time.
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FDA acknowledged feedback and comments from industry since the 2019 Compliance Policy announcement over “industry-wide readiness for implementation of the verification of saleable returned product requirement for wholesale distributors and the challenges stakeholders face with developing interoperable, electronic systems to enable such verification and achieve interoperability between networks.”
FDA pointed to the following stakeholder issues:
- Continuing challenges posed by the large volume of saleable returned product. More time is needed for distributors to test verification systems with real-time volumes vs. small scale pilot volumes of returned product.
- Significant delays in testing verification systems due to the priority of responding to the COVID-19 pandemic, “namely the reassignment of logistics and supply chain experts from DSCSA matters to COVID-19 pandemic response.”