The US Food and Drug Administration (FDA) issued the draft guidance this week, which elaborates on industry standards relating to the Drug Supply Chain Security Act (DSCSA).
The DSCSA outlines steps to build an electronic, ‘interoperable’ system – meaning to exchange product tracing information accurately, efficiently and consistently – to identify and trace certain prescriptions medicines in the US.
The FDA said the system, which is currently electronic and paper-based, will be electronic only and fully implemented by 2023.
The Standardisation of Data and Documentation Practices for Product Tracing draft guidance sets new recommended data standards, to help inform trading partners in the drug supply chain – from manufacturers to pharmacies – on the product tracing information they must provide, capture and maintain.
The guidance also offers recommended documentation practices for trading partners in order to meet product tracing requirements – including in situations where they are legally allowed to omit information, said the agency.
Commissioner Scott Gottlieb said the guidance responds to a need to evolve US practices to use the most up-to-date technologies, to impede “increasingly more sophisticated threats” to the drug supply system.
“The new steps will reduce the risk of harmful drugs reaching patients by allowing us to identify and trace certain prescription drugs as they are distributed throughout the US,” he added.
The FDA also released a guidance outlining its interpretation of terms relating to drug supply chain security.
The Definitions of Suspect Product and Illegitimate Product for Verification Obligations draft guidance clarifies the FDA’s interpretation of ‘suspect product’, ‘illegitimate product’, ‘counterfeit’, ‘diverted’, ‘fraudulent transaction’, and ‘unfit for distribution’.