Track and Trace refers to the process of tracking the movement of a product through the supply chain from its point of manufacture to its point of sale. The goal of track and trace is to ensure the authenticity, integrity, and security of products and protect consumers from counterfeit, falsified, or substandard products.
In the United States, the Food and Drug Administration (FDA) has established a track and trace system for certain products, known as the "Drug Supply Chain Security Act (DSCSA)" which aims to improve the safety and security of the drug supply chain. This law mandating the pharmaceutical companies, wholesale distributors, repackagers and dispensers to comply with a serialization, verification, and reporting requirements.
This track and trace system requires pharmaceutical companies to place unique product identifier (UPI) on the packaging of certain prescription drugs. This UPI includes a product identifier that is a unique numerical identifier, and a serial number that is a unique alphanumeric identifier assigned to each package of the product.
The law also requires that all trading partners of the supply chain must verify the UPI of each drug product, by using the Product Identifier Verification System (PIVS) which provided by FDA. The DSCSA also requires that companies must report certain information to FDA, including transactions and transactions rejections, suspect product and illegitimate product.
The ultimate goal of this system is to give regulators the ability to quickly and easily track the movement of drugs through the supply chain in order to identify and remove counterfeit, falsified, or substandard drugs from the market. This will help to protect consumers by ensuring that they receive authentic and safe drugs and also will reduce the risk of counterfeit drugs entering the market.
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