US Track and Trace System

Recommendation

7/8 May 2024

Extractables & Leachables - Live Online Training
Challenges and Solutions for Packaging and Single Use Systems

According to the Delegated Regulation (EU) 2016/161, marketing authorization holders (MAHs) are required to ensure that unique identifiers (UIs) are uploaded to the Union repository system before a product is released for sale or distribution. This is mandatory for most prescription medicines since 9 February 2019. The manufacturer is actually affixing the UI and the anti-tampering device on the packaging.

Recently, FDA launched a new pilot project in which participants representing the drug supply chain (e.g., manufacturers, repackagers and other stakeholders) can pilot the use of innovative and emerging approaches for enhanced tracing and verification of prescription drugs in the US.  According to the agency, the interoperable track-and-trace system for industry is set to go into effect in 2023.

Pilot Project Focus

Pilot project focus areas are:

• PI - Product Identifier [affix or imprint PI; methods used to issue and manage serial numbers (e.g., including a contract manufacturer's role); different representations for the PI (e.g., different formats of the National Drug Code or serial number)]
• Barcodes [Readability; linear barcode and 2D barcode, distinguishing which barcode to read/use]
• Data/ Database/ System Issues [data quality from beginning to end of the product lifecycle, system performance, data format, integration into individual/ company data systems, data governance, ability of the system to record product status (e.g., to indicate expired, illegitimate, in error, quarantined)]
• Aggregation/ Disaggregation [how can errors be corrected?]
• Verification/ Notification [process for investigation of suspect or illegitimate product, including any communication or coordination]
• Exception Handling/ Errors/ Inconsistencies [Identify `honest errors' (e.g., over/under shipments, clerical errors, or aggregation errors); Correcting `honest errors']
• Special Scenarios [Situations when data and product do not move together or when serialized products are sold and distributed along with non-serialized products]

For more information, please see FDA´s program announcement "Pilot Project Program Under the Drug Supply Chain Security Act".