FDA Drug Supply Chain Security Act (DSCSA)

Evaluate DSCSA compliance for pharmaceutical track-and-trace, serialization, verification, and transaction history requirements

PharmaBiotechHealthcareDistribution25 minutes18 questions

1. Serialization & Product Tracing

Are products serialized with unique identifiers (SNDCs)?*

Standardized Numerical Identifier (SNI) on each package/homogeneous case - 2D barcode with GTIN, serial, lot, expiration

Can you capture and maintain transaction history, information, and statement (T3)?*

Track transaction data at package level through supply chain (manufacturer to dispenser)

Is product tracing capability established (48-hour response to FDA/trading partner)?*

Trace product one step forward/back in supply chain within 2 business days

2. Transaction Information

Do transaction documents include all required DSCSA data elements?*

Product identifier, quantity, ship-to/from info, transaction date, lot number, expiration

Are transaction statements obtained confirming trading partner legitimacy?*

Statement that entity is licensed, product authentic, transaction legitimate

Are transaction records retained for 6 years?*

DSCSA §582: Maintain T3 records electronically for 6 years from transaction date

3. Verification Requirements

Do you verify product identifiers upon receipt of suspect/high-risk products?*

Verify SNI authenticity through manufacturer/solution provider for suspect products

Can you verify product identifiers in response to verification requests?*

Respond to downstream trading partner verification requests within 24 hours

Do you verify saleable returns before restocking?*

Verify product identifier for returned products prior to further distribution

4. Systems & Interoperability

Are systems capable of exchanging EPCIS (Electronic Product Code Information Services) data?*

Interoperable track-and-trace system using GS1 standards (EPCIS, CBV)

Can your system handle unit-level (package) serialization data?*

Enhanced drug distribution security - unit-level traceability (2023 compliance)

Are master data (GTIN, company info) maintained and synchronized?*

Accurate product/company master data in National Council for Prescription Drug Programs (NCPDP) or GS1 registries

5. Suspect & Illegitimate Products

Are procedures in place to identify suspect products?*

DSCSA §581: Product with high probability of being counterfeit, diverted, stolen, unfit, or adulterated

Do you quarantine and investigate suspect products?*

Quarantine within 24 hours, verify within 5 days, notify trading partners/FDA if illegitimate

Are illegitimate products reported to FDA and trading partners?*

Notify FDA within 24 hours, notify immediate trading partners

6. Returns & Repackaging

Are authorized trading partners verified (state license, DEA registration)?*

DSCSA §582: Verify trading partner authorized in state/federal registries

Do repackagers affix new SNI and maintain parent-child linkage?*

Repackagers: New 2D barcode, maintain relationship to original SNI in system

Are returned products verified before redistribution?*

Verification of product identifier for all saleable returns

Please answer all required questions to see your results