November 26, 2014
FDA Releases TI/TH/TS Draft Guidance for Tracing Prescription Drugs
The Food and Drug Administration (FDA) has released draft guidance for industry with respect to the interoperable exchange of transaction information, transaction history, and transaction statements (TI/TH/TS) for the tracing prescription drugs through the supply chain.
HIDA will provide a more detailed summary early next week; however, in summation, the FDA has reinforced many of the recommendations (e.g., multiple paper and electronic options for TI/TH/TS) supported by HIDA and the industry to ensure all stakeholders can comply with the new traceability requirements beginning January 1, 2015.
Key Takeaways from FDA Draft Guidance:
Trading partners can utilize current paper-based or electronic-based methods for the interoperable exchange of data to provide product tracing information to subsequent purchasers as long as the selected method(s) allow information to be exchanged in a manner that complies with the requirements of section 582 (b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act. Such methods could include, but are not limited to, the use of:
- Paper or electronic versions of invoices
- Paper versions of packing slips
- Electronic Data Interchange (EDI) standards, such as Advance Ship Notice (ASN), which is currently used to provide the receiving entity with advance data on shipments
- EPCIS (Electronic Product Code Information Services), which defines a data-sharing interface that enables supply chain partners to capture and communicate data about the movement and status of objects in the supply chain
- Email or Web-based platforms (such as Web portals) are acceptable means to transmit or access the product tracing information, as long as the information is captured, maintained, and provided in compliance with section 582
Stay tuned for additional analysis from HIDA.
Please contact HIDA Government Affairs if you have any questions, HIDAGovAffairs@HIDA.org or 703-838-6133.