FDA Unveils Draft Guidance on Track and Trace
The US Food and Drug Administration (FDA) on Thursday unveiled two new draft guidances to interpret certain terms and elaborate on the standards for the exchange of certain transaction information, history and statements.While noting that FDA plans to hold a public meeting to establish an interoperable, electronic product tracing system at the package level, Commissioner Scott Gottlieb said in a statement: “Establishing a truly interoperable system requires setting standards and using consistent terms to ensure the data is captured and shared in a way that allows various systems involved in the supply chain – from manufacturers to pharmacies – to communicate with one another.”
The 23-page guidance on the standardization of data and documentation practices for product tracing deals with transaction statements required by section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which was added by the Drug Supply Chain Security Act (DSCSA).
Although the requirements on product tracing information took effect in 2015, FDA said this guidance also addresses how the tracing requirements of section 582 apply to certain prescription drugs that entered the pharmaceutical distribution supply chain before 2015.
The other seven-page guidance defines suspect product, illegitimate product, as well as the terms counterfeit, diverted, fraudulent transaction and unfit for distribution.
Standardization of Data and Documentation Practices for Product Tracing: Draft Guidance for Industry
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act