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DSCSA
COVERAGE.
Responsible for affixing unique product identifiers (PI) to each saleable unit. Must submit EPCIS events at shipment and maintain transaction records for 6 years. Origin point for all traceability chains.
AEROZ_COVEREDMust re-serialize any repackaged product, provide new product identifier, and transmit updated TI/TH/TS to downstream trading partners. Treated as manufacturer for serialization obligations on repackaged units.
AEROZ_COVEREDMust verify product identifiers, check for suspect/illegitimate product, pass transaction data to downstream ATPs, and conduct saleable returns verification. Must be licensed under §503(e).
AEROZ_COVEREDPharmacies and health systems must verify saleable returns via VRS, investigate suspect products, quarantine illegitimate product, and notify FDA within 24 hours of positive identification.
AEROZ_COVEREDThird-party logistics providers must maintain storage and handling records, pass transaction data upon request, and be licensed under state law where they operate. Cannot initiate or accept transactions without ATP status.
AEROZ_COVEREDEvery sellable unit must carry: National Drug Code (NDC) in standardized format, a unique Serial Number per unit, Lot Number, and Expiration Date. All four encoded in both human-readable and machine-readable (DataMatrix or NFC) form.
FDA requires machine-readable encoding per GS1 standards. 2D DataMatrix is preferred for unit-level; GS1-128 for homogenous cases and pallets. Aeroz NFC tags embed the same PI structure in cryptographically signed NDEF records for digital chain-of-custody.
All transaction documentation — TI, TH, and TS — must be stored and retrievable for 6 years from date of transaction. Must be producible to FDA within 2 business days upon request. Electronic format required as of November 27, 2023.
The final rule mandates EPCIS 2.0 (GS1 Electronic Product Code Information Services) as the interoperability standard. All ATPs must be capable of sending and receiving EPCIS-formatted transaction data electronically. XML and JSON-LD serializations both supported.
Manufacturer assigns serial number to physical unit. Creates the root traceability record for the product identifier. Must be submitted before first transfer of ownership.
Records transfer of custody from one ATP to the next. Triggers TI + TS generation. Receiving party must confirm acceptance before SHIP event is complete. Required at every ownership transfer.
Confirmation of receipt and verification of product identifier against upstream EPCIS record. Triggers VRS lookup for returns. System must reconcile PI against transaction data received from seller.
Associates individual unit-level PIs with a homogeneous case SSCC. Required when shipping aggregated cases. Enables downstream parties to verify case contents without scanning individual units.
Disaggregates case or pallet into individual unit-level records. Must be transmitted before any units within a case are transferred as individual saleable units to downstream parties.
Dispenser or wholesale distributor returns product to upstream party. Receiving party must perform VRS verification within the Verification Router Service prior to accepting the return into saleable inventory.
Records destruction, expiration removal, or removal from supply chain. Product identifier must be decommissioned in GS1 system to prevent reuse. Required for recalled, destroyed, or expired product.
| EVENT_TYPE | ACTION | DESCRIPTION | REQUIRED BY |
|---|---|---|---|
| ObjectEvent | Commissioning | Manufacturer assigns serial number to physical unit. Creates the root traceability record for the product identifier. Must be submitted before first transfer of ownership. | MANUFACTURER |
| ObjectEvent | Shipping / SHIP | Records transfer of custody from one ATP to the next. Triggers TI + TS generation. Required at every ownership transfer. | ALL ATPs |
| ObjectEvent | Receiving / RECV | Confirmation of receipt and verification of product identifier against upstream EPCIS record. Triggers VRS lookup for returns. | ALL ATPs |
| AggregationEvent | Pack / PACK | Associates individual unit-level PIs with a homogeneous case SSCC. Required when shipping aggregated cases. | MFR / WD |
| AggregationEvent | Unpack / UNPACK | Disaggregates case or pallet into individual unit-level records. Must be transmitted before units are transferred as individual saleable units. | WD / DISPENSER |
| TransactionEvent | Saleable Return | Dispenser or wholesale distributor returns product to upstream party. Receiving party must perform VRS verification prior to accepting the return into saleable inventory. | WD / DISPENSER |
| ObjectEvent | Decommission | Records destruction, expiration removal, or removal from supply chain. Product identifier must be decommissioned in GS1 system to prevent reuse. | ALL ATPs |
DSCSA Signed Into Law
Title II of the Drug Quality and Security Act (DQSA) enacted, establishing a 10-year phased framework for electronic, interoperable traceability. Replaced state pedigree laws with federal standard. Initial requirements for lot-level TI/TH/TS documentation.
Saleable Returns Verification
Wholesale distributors required to verify product identifiers on saleable returns before redistribution. First major enforcement milestone requiring physical verification infrastructure at distribution centers.
Dispenser Saleable Returns Verification
Dispensers (pharmacies, hospitals, clinics) required to verify product identifiers on saleable returns before returning to wholesale distributors. Extended VRS infrastructure requirement to the dispenser tier.
Electronic Interoperable Unit-Level Traceability
Full DSCSA mandate effective. All ATPs must exchange transaction data electronically using interoperable systems. Unit-level serialization required at every transfer of ownership. EPCIS 2.0 standard mandated. Paper-based TI/TH/TS no longer compliant.
FDA Enforcement Activity & Guidance Clarifications
FDA issuing warning letters and conducting facility inspections for DSCSA non-compliance. Guidance documents published on VRS operation, EPCIS implementation, and ATP identification requirements. Trading partners without interoperable systems face removal from distribution networks.
FDA may place a hold on products distributed without compliant PI or EPCIS records, preventing sale or further distribution. Product seizure under 21 U.S.C. §334 for products whose traceability records are unavailable or fraudulent.
Trading partners are required to cease transactions with non-compliant entities under the ATP verification obligation. Loss of ATP status effectively shuts off product supply. Major wholesalers and GPOs actively auditing for DSCSA compliance.
FDA has issued warning letters citing DSCSA non-compliance as part of broader enforcement actions. Warning letters are publicly available and trigger enhanced scrutiny in subsequent inspections. Response required within 15 business days.
NOT OPTIONAL.
Full enforcement has been in effect since November 27, 2023. Aeroz infrastructure is purpose-built to fulfill every DSCSA obligation at every node of your distribution chain — from fill line to dispenser.