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The Pharmaceutical Distribution Security Alliance (PDSA)

Pharmaceutical Distribution Security Alliance

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These slides are a short overview of a proposed supply chain traceability infrastructure proposed by PDSA.

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Page 1: Pharmaceutical Distribution Security Alliance

The Pharmaceutical Distribution Security Alliance(PDSA)

Page 2: Pharmaceutical Distribution Security Alliance

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

Page 3: Pharmaceutical Distribution Security Alliance

The Pharmaceutical Distribution Security Alliance(PDSA)

A National Enhancement for Patient Safety and Distribution Chain Security