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These slides are a short overview of a proposed supply chain traceability infrastructure proposed by PDSA.
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The Pharmaceutical Distribution Security Alliance(PDSA)
Transitional Requirements:• Manufacturing Packing List• Distribution History• Returns• Authorized Distributor of Record
Federal Standards for Licensure:• State Licensure for Wholesale
Distributors• Third-Party Logistics Provider• Manufacturers• Repackager• Registry of Online Pharmacy
Stronger Penalties for Counterfeit
Technology Requirements:• E-Labeling• RxTEC Code
• Manufacturer systems for lot level traceability and verification of individual saleable units
• Distributor and Dispenser Lot Level Product Traceability
• Interoperability
A National Enhancement for Patient Safety and Distribution Chain Security
The Pharmaceutical Distribution Security Alliance(PDSA)
A National Enhancement for Patient Safety and Distribution Chain Security