The United States has the most comprehensive pharmaceutical supply chain security framework in the world through the Drug Supply Chain Security Act (DSCSA). Full DSCSA interoperability has been required since November 2023.
Regulatory Authority
The US Food and Drug Administration (FDA) enforces DSCSA through the Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA). The FDA conducts inspections, issues warning letters, and can refuse entry of non-compliant products.
Key Requirements
US pharmaceutical supply chain participants must: serialise products at the saleable unit level; exchange transaction data electronically using EPCIS; verify saleable returns before redistribution; only transact with authorised trading partners; and investigate and report suspect/illegitimate products.