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Global Compliance

United States

The industry is rapidly adapting to a new normal of serialization and track and trace as the Drug Supply Chain and Security Act (DSCSA) goes into effect. With serialized product now entering the supply chain, pharmaceutical manufacturers, repackagers, wholesale distributors, and hospitals and pharmacies are preparing and anticipating exactly what challenges and opportunities come next. The industry learned under lot-level mandates and related trade partner requirements and those learnings will continue as we move to the serialization, verification, and track and trace phases of the law.

DSCSA Requirements

Serialization. Manufacturers must mark the lowest saleable unit with a 2D data matrix code that includes four data elements — a product identifier, serial number, lot or batch number, and an expiry date.

Verification. Serial numbers must be verified when a returned product is to be sold back into the commercial supply chain or in response to investigating suspect or illegitimate products.

Transactional information exchange. Transactions are provided to trade partners as part of a change of ownership and include transaction information (TI), transaction history (TH), and transaction statement (TS).

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