The US Food and Drug Administration (FDA) will allow trading partners to track drug products through the pharmaceutical supply chain using portals and email exchanges to accommodate the needs of smaller pharmacies who may not have the encrypted Internet connections for exchanging of Electronic Product Code Information Services (EPCIS) information.
This pronouncement was made in FDA’s final guidance on the use of electronic standards for tracing products through the pharmaceutical supply chain. The Drug Supply Chain Security Act (DSCSA) mandates that enhanced drug tracking requirements go into effect on 27 November 2023, though FDA recently announced that this requirement will not go into effect until a year later. (RELATED: FDA gives firms one-year reprieve from DSCSA track and trace requirements, Regulatory Focus 25 August 2023)…
