Draft guidance released by FDA on Product tracing requirements


A draft guidance namely “Standardization of Data and Documentation Practices for Product Tracing” has been released by FDA to help trade partners in standardizing the data needed for ensuring the trace ability of products.

Manufacturers, re packers, wholesalers and dispensers.come under trade partners. According to the US FD&C Act, trade partners must supply the subsequent purchaser with trace ability data for specific prescription drugs.
The guideline states that Trade partners have to store the product trace ability data for no less than 6 years, starting from the date of the transaction. Other requirements for data standardization as laid down by section V of FDA guideline include:

• 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

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