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The Florida law requires careful tracing of every package of drugs from first purchase from a manufacturer until distributed to a pharmacy, but without the benefit of a serial number attached to each unit.
GS1 US defines traceability (in healthcare) as the process that \u201cenables you to see the movement of prescription drugs or medical devices across the supply chain. You can trace backwards to identify the history of the transfers and locations of a product, from the point of manufacture onwards.
A drug pedigree is a record of each distribution of a prescription drug from its sale by a manufacturer through acquisition and sale by any wholesale distributor until final sale to a pharmacy or other authorized person administering or dispensing the prescription drug.
A track & trace system is a software-based solution to track vehicles, loading units, shipments or products throughout the entire supply chain, from supplier to consumer. If it concerns vehicles, a track & trace system is also called a vehicle tracking system.
In the pharmaceutical industry, traceability has three main benefits; it increases supply chain visibility, improves quality control systems, and reduces the risk of introducing counterfeit medication into the market.
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According to the US Food and Drug Administration (FDA) in the 2006 Compliance Policy Guide for the Prescription Drug Marketing Act, \u201ca drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties ...
To date, the DSCSA has focused on lot-level traceability, or exchanging information about every package of medication so supply chain stakeholders can see exactly where each has been.
Track and trace technologies enable a product's status to be captured through the value chain, and to retrospectively identify and verify its path.
Transaction Statement The DSCSA requires that a product shall not be received into the receiving trading partner's inventory until a complete and accurate Transaction Report is provided by the trading partner shipping the product.
Pharmacy returns must be reflected on pedigrees What it means is that when a pharmacy buys drugs from someone and they return those drugs, regardless of how little time has transpired, they must provide a pedigree update so that subsequent buyers of those drugs can see their purchase, and return transactions.

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