Which law requires serialization and track-and-trace of prescription drugs to enhance drug supply chain security?

• A. Prescription Drug Marketing Act
• B. Federal Food, Drug, and Cosmetic Act
• C. Food Safety Modernization Act
• D. Drug Supply Chain Security Act (DSCSA)

Answer: (D)

Serialization and track-and-trace are built into the Drug Supply Chain Security Act, a 2013 amendment designed to bolster the security of prescription drugs as they move through the supply chain. This law requires each package to carry a unique product identifier and establishes an interoperable system for capturing and sharing transaction information, history, and statements as drugs flow from manufacturers to distributors, wholesalers, and pharmacies. With these controls, regulators and supply-chain participants can verify authenticity, quickly spot suspect or counterfeit products, and trace their path to pinpoint where a problem arose. The other acts cover different areas (such as general drug marketing protections or food safety) and do not establish the national serialization and tracing framework that DSCSA provides.