On February 28, 2018, FDA issued draft guidance on Standardization of Data and Documentation Practices for Product Tracing. FDA aims to provide trading partners information to appropriately track product information through the pharmaceutical distribution supply chain, in compliance with requirements that took effect in 2015 as part of section 582 of the Federal Food, Drug, and Cosmetic Act.
The draft guidance provides information on defining trading partners, standardizing data that trading partners should track, and appropriate documentation practices that satisfy statutory obligations.
FDA recognizes that an entity may meet the definition of more than one type of trading partner, depending on the activities it in which it engages. To be considered an authorized trading partner, an entity must have the applicable registrations and licenses for the type of activities it undertakes.
The draft guidance enumerates ten pieces of standardized “transaction information” that trading partners are required to track: (1) proprietary or established name; (2) strength and dosage form; (3) national drug code number; (4) container size; (5) number of containers; (6) lot number; (7) date of the transaction; (8) date of shipment; (9) business name and address of the person from whom ownership is being transferred; and (10) business name and address of the person to whom ownership is being transferred. Trading partners should also track the transaction history of products, either by compiling data from prior transactions or creating a single document with historical information.
Finally, FDA provides guidance on what documentation a trading partner should exchange when conducting specific types of transactions. This information generally includes the enumerated transaction information, transaction history, and transaction statement, as defined in the Federal Food, Drug, and Cosmetic Act. FDA further provides specific documentation guidance for drop shipments to dispensers and grandfathered products (those that entered the pharmaceutical supply chain before 2015).