Comply with Traceability requirements
Track every stock move with RxERP's unique double-entry inventory system.
Track every stock move from purchase to warehouse bin to sales order. Trace lots or serials upstream or downstream from anywhere in your supply chain.
Track and Trace Compliance
Easy traceability for healthcare and pharmaceutical industries
The Drug Supply Chain Security Act (DSCSA) was passed by Congress in 2013 and signed into law by President Obama on November 27th, 2013. The DSCSA is Title II of the Drug Quality and Security Act (DQSA). The new law establishes requirements which include lot-based tracking of prescription pharmaceuticals via EDI 856 ASN from the manufacturer to the dispenser from 2015 to 2023 and serialization tracking (EPCIS) after 2023. Drug manufacturers must apply unique identifiers on all prescription drug packages by November 2017 and repackagers, wholesale distributors and dispensers must begin to buy and sell products marked with those identifiers by November of 2018, 2019 and 2020 respectively.
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A formal document known as the 3T's (TI, TH, and TS) are required to be exchanged between trading partners in the pharmaceutical supply chain, including all previous owners of a prescription drug, going all the way back to the original manufacturer of the product and stored for a minimum of 6 years.
1. Transaction Information (TI) : Includes the name of the product, strength and dosage form, NDC number, container size, number of containers, lot number, transaction date, shipment date and the name and address of the businesses which was the previous owner of the product.
2. Transaction History (TH) : An electronic statement that includes the transaction information for each prior transaction back to the manufacturer.
3. Transaction Statement (TS) : A statement, in paper or electronic form, that the entity transferring ownership in a transaction has complied with each applicable subsection of FDCA Sec. 581 (27) (A)-(G).
The Drug Supply Chain Security Act impacts all organizations in the pharmaceutical supply chain.
3rd Party Logistics
Pharmacies / Dispensers