Pharmaceutical distributors seek two-year delay in DSCSA tracking rules
Pharmaceutical distributors are calling for the US Food and Drug Administration (FDA) to grant a two-year delay enforcing the pharmaceutical tracking provisions of the Drug Supply Chain Security Act (DSCSA), saying that industry still does not have the necessary tracing systems in place to comply with the law. The Healthcare Distribution Alliance (HDA) is instead calling for a phased approach to implementation to minimize supply chain disruptions and avoid drug shortages.Scott Mooney, vice-president of distribution operations for McKesson explained the HDA’s request and why the group is calling for the enforcement delay during a 27 July webinar.
Beginning on 27 November 2023, DSCSA requires manufacturers, wholesalers, distributors and dispensers to exchange serialized product information, and marks the culmination of the law’s phased implementation.
“There are a lot of changes coming up this November, and industry has been working very hard to get ready for these changes,” said Mooney. “But as of today, we are now four months from the go live date. This is the date when everything has to happen all at once in the supply chain. The manufacturer has to send serialized data to the distributor and the distributor has to send serialized data to dispenser.”
Yet while a “great number of suppliers” are making these connections, he said that “for some reason we are not seeing the data flow in quite yet.”
Mooney said that only 35% of manufacturers are sending serialized data to distributors. This situation is prompting “significant concern” that most products will not be serialized in time to meet the 27 November deadline, forcing products into quarantine, and could potentially lead to supply disruptions.
This situation prompted HDA to request an extension in a 2 June letter to FDA. The letter states that instead it favors a phased approach to implementation, stating that “simply extending the compliance date without a rational phase-in just moves the date on which the problems and issues become apparent once again.”
During the first phase, which would run from 27 November 2023 to 26 November 2024, manufacturers would “ramp up and stabilize their provision of package-level data” to wholesaler distributors with each prescription drug transaction or obtain an exemption from FDA.
In the second phase, from 27 November 2024 to 26 May 2025, manufacturers must comply with all DSCSA requirements and provide package level data to wholesale distributors or obtain an exemption from FDA. For their part, wholesale distributors would “ramp up and stabilize their provision of package level data to dispensers with each prescription drug transaction and would also continue providing lot-level data to dispensers so that prescription drugs continue to move in the supply chain to patients.”
During the third phase, from 27 May 2025 to 26 November 2025, manufacturers and wholesale distributors “must comply with all DSCSA requirements and provide package-level data to their customers (including dispensers) with each prescription drug transaction.”
Tish Pahl, an attorney with Olsson Frank Weeda Terman Matz PC, told the group that the phased approach “gives time for trading partners to stabilize the data exchange and to … work on the data accuracy issues that we know are there and to recognize that inaccurate data would otherwise result in product stoppage. The phased approach is designed to keep the good product flowing to patients while also at the same time working on that data quality.”
HDA webinar
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