Product tracing - new FDA requirements

Recommendation

21 June 2023
Hamburg, Germany

QP pre-course Session: Interpersonal and Soft Skills for the QP

In March 2018, die FDA has published their draft Guidance for Industry "Standardization of Data and Documentation Practices for Product Tracing". This Guidance is supposed to help trade partners in standardising the data needed for ensuring the traceability of products.

Trade partners include manufacturers, repackers, wholesalers and dispensers. According to the US FD&C Act, trade partners must supply the subsequent purchaser with traceability data for specific prescription drugs. In this FDA guideline, the term "subsequent purchaser" also includes the term "subsequent owner".

Trade partners have to store the product traceability data for no less than 6 years, starting from the date of the transaction.

Section V of the FDA guideline provides requirements for the data standardisation:

• Product name
• Strength
• Dosage form
• National drug code number of the product
• Container size
• Number of containers
• Date of transaction
• Date of transport, in case it lies more than 24 hours behind the date of transaction
• Name and address of the person the product is being transferred from
• Name and address of the person the ownership is being transferred to

Please also see the complete FDA draft guidance "Standardization of Data and Documentation Practices for Product Tracing".