Global Track & Trace

美国药品供应链安全法（DSCSA）是一项联邦法规，旨在增强药品在供应链中的安全性和可追溯性。DSCSA 于 2013 年颁布，旨在通过解决与假冒、掺假或其他受损药物相关的问题来保护公共健康。
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The DSCSA was designed as a phased, ten-year implementation. The final and most significant phase — requiring fully electronic, interoperable tracing of prescription drugs at the individual serialized package level — took effect on November 27, 2023. Following widespread industry concern about readiness, the FDA issued a one-year stabilization period, during which no enforcement action was taken against trading partners working to implement the enhanced drug distribution security requirements. That stabilization period ended on November 27, 2024.

In October 2024, the FDA issued further exemptions for eligible trading partners who had made documented efforts to connect electronically with their immediate trading partners but needed additional time to finalize interoperable systems. Under those exemptions, manufacturers and repackagers reached full enforcement as of May 27, 2025, with wholesale distributors following on August 27, 2025. Dispensers with 26 or more full-time licensed employees are subject to full enforcement by November 27, 2025, and small dispensers with fewer than 26 licensed employees have until November 27, 2027.

All supply chain trading partners — manufacturers, repackagers, wholesale distributors, and dispensers — are required to exchange Transaction Information, Transaction History, and Transaction Statements (T3 data) electronically in a standardized format, typically EPCIS, when transferring ownership of covered drug products. Each saleable unit must carry a product identifier encoding the National Drug Code (NDC), serial number, lot number, and expiration date. The DSCSA also establishes requirements for handling suspect and illegitimate products, enabling prompt investigation and removal from the supply chain.For the most current FDA guidances and enforcement timelines, refer to the official resources linked below.