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340B Under DSCSA: How to Close the Gap Between Data Flow and Product Flow

For the past 30 years, the 340B Drug Discount Program has had a tremendous impact on patient health, improving access to affordable medications for vulnerable populations. The U.S. Drug Supply Chain Security Act indirectly supports this effort by improving supply chain traceability, ensuring the safety of medications flowing through the supply chain.

For 340B-covered entities, their contract pharmacies, and the wholesale distributors that send them product, the impact of the DSCSA’s serialized product data exchange requirement on the products they dispense has been a constant source of confusion. We recently caught up with Dan Walles, General Manager of Traceability & Compliance at TraceLink, to discuss why 340B shipments are difficult to coordinate under the DSCSA and how to better handle these shipments in compliance with the law.

What happens in a 340B shipment?

What makes a 340B shipment unique compared to other shipment scenarios is the divergence of the physical product from product ownership. When a health system orders a 340B-covered medication from its wholesale distributor, the health system retains ownership of the product while the physical product is shipped to the contract pharmacy that dispenses it. Read more >

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