DSCSA T2 Documents — Transaction Information & Statement

DSCSA Documents Under EPCIS Interoperability

With EPCIS-based interoperability now in effect, only two documents — Transaction Information (TI) and Transaction Statement (TS) — are required with every drug transfer. Together these are known as the T2 documents. Transaction History (TH), which was required under legacy pre-EPCIS workflows, is eliminated because the EPCIS event stream provides a richer, real-time chain of custody.

Premier Pharma can help eligible buyers review available T2 and serialization workflow support; the account does not replace a business's compliance program or official guidance.

Transaction Information (TI)

The TI must include:

• Proprietary or established name of the product
• Strength and dosage form
• NDC number
• Container size and number of containers
• Lot number(s)
• Transaction date
• Shipment date (if different from transaction date)
• Name and address of the business from which ownership is being transferred
• Name and address of the business to which ownership is being transferred

Transaction History (TH) — Eliminated Under EPCIS

Under the legacy pre-EPCIS workflow, a Transaction History was a paper trail of all previous ownership transfers tracing back to the manufacturer. With EPCIS interoperability now in effect, Transaction History is no longer required — the real-time EPCIS event stream replaces it with a richer, standardized electronic record. You do not need to request or retain Transaction History from compliant distributors.

Transaction Statement (TS)

The TS is a signed attestation from the transferring trading partner stating that:

• It is authorized under DSCSA
• The product being transferred is not suspect or illegitimate
• The product identifiers on the product have been verified
• The product has been handled in accordance with DSCSA

Retention Requirements

All T2 documents (TI + TS) must be retained for 6 years from the date of the transaction. This applies regardless of your license type — dispensers, wholesale distributors, and repackagers all have the same 6-year requirement.

Electronic T2 Documents and EPCIS

T2 documents must be transmitted electronically under DSCSA interoperability requirements. Electronic transmission enables:

• Faster dispute resolution
• Automated 6-year archiving
• Seamless response to FDA requests
• Full integration with EPCIS serialization event data

Account holders can ask about available transaction-document and serialization record workflows through the customer portal.

What Happens If You Can't Produce T2 Documents?

If the FDA requests T2 documents and you cannot produce them within the required timeframe, you may face:

• Warning letters and formal enforcement action
• Fines up to $250,000 for the first violation
• Suspension of your license to receive pharmaceutical product
• Criminal referral in cases involving controlled substances

Maintaining complete, searchable T2 records (TI + TS) for every shipment is one of the most important DSCSA compliance steps a pharmacy can take.