Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry

On February 28, 2018, FDA issued draft guidance on Standardization of Data and Documentation Practices for Product Tracing. This draft guidance aims to provide trading partners information to appropriately track product information through the pharmaceutical distribution supply chain, in compliance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The draft guidance provides information on defining trading partners, standardizing data that trading partners should track, and appropriate documentation practices that satisfy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.

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The draft guidance describes ten pieces of standardized “transaction information” that trading partners are required to track: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

(10) business name and address of the person to whom ownership is being transferred.

The guidance also provides guidance on what documentation a trading partner should exchange when conducting specific types of transactions. FDA further provides specific documentation guidance for drop shipments to dispensers and grandfathered products (those that entered the pharmaceutical supply chain before 2015).

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