Chapter 8.1: Supply Chain, Restricted Programs, and Waste Management

what is the DSCSA?

• drug supply chain security act passed in 2013

• their goal is to create an electric shield around the drug supply

• they mandate “interoperable electric systems” capable of identifying and tracing every Rx distributed in the US

• count boxes to verify that quantity matches invoice and verify electronic data associated with a specific bottle matches the physical product

what is linear barcode

• old

• good for inventory but only identifies product type, cannot distinguish bottles from another

what is serialization

• a digital “license plate'“

what does the 2D DataMatrix Barcode contain?

• NDC (National Drug Code)

• serial number: unique code assigned to that specific bottle

• lot number: manufacturing batch for recalls

• exp date

what is SNI?

• standardized numerical identifier (SNI)

• made of NDC and serial number

• verifies that bottle is authentic and not stolen/recalled

what is transaction data?

• the history of ownership

  • when manufacturer sells to wholesaler → wholesaler sells to pharmacy, specific data is exchanged to ensure chain of custody is not broken

  • ensures the products are legit and not fake/stolen

what are the 3 Ts for transaction data?

• transaction info (TI)

• transaction history (TH)

• transaction statement (TS)

what is TI?

• transaction info

  • the product itself

  • includes proprietary/established drug name, strength, dose, NDC, container size, lot number, and date of shipment

what is TH?

• transaction history

  • document product journey

  • complete ledger listing every prior owner of the product, tracking back to manufacturer

    • if there’s a gap, integrity is compromised

what is TS?

• transaction statement

  • validates legitimacy of transfer

  • legal affirmation from seller stating that they are authorized to sell the product, they’ve received it from an authorized party, the transaction info is accurate and product is not fake/stolen

how long should a pharmacy keep transaction data for (TI, TH, TS)?

• a minimum of 6 years which is longer than standard record-keeping requirement