3.3 T3 Transaction Data — TI, TH & TS

The Three Transaction Documents — TI, TH, TS

Before November 27, 2023, DSCSA's tracing backbone was a trio of documents PTCB and the industry call "T3" (or "transaction data") — a shorthand, not a term the statute itself uses. Each transaction in a covered product — from manufacturer to repackager to wholesale distributor to dispenser — had to be accompanied by three pieces of information. Two of the three, TI and TS, are still required today; the third, TH, is not. The exam tests the distinctions among all three and, just as importantly, tests which ones are still in force.

Transaction Information (TI)

Transaction Information (TI) is the data specific to a particular transaction: the product, lot number(s), date of the transaction, quantity, and similar transactional details. TI answers "what was sold, in what quantity, on what date, and in what lot." TI is generated for each sale, travels with the product as it moves downstream, and remains required today.

Transaction History (TH) — No Longer Required

Transaction History (TH) was the chain-of-ownership record — the cumulative list of transactions tracing the product back to the manufacturer, defined in FD&C section 581(25). TH included the TI from each prior transaction in the chain, so a dispenser could see the full path: manufacturer → repackager → wholesale distributor → dispenser.

Under section 582(k)(1), the requirement for trading partners to provide and receive TH ended on November 27, 2023 — a flat statutory sunset date that applies across the board, not something that phases in trading-partner by trading-partner the way EDDS compliance dates do. Package-level serialization took over TH's tracing role. A guide, question, or study source that presents TH as a current requirement is out of date.

Transaction Statement (TS)

Transaction Statement (TS) is the seller's attestation — a statement by the seller that the product is not counterfeit, not diverted, not stolen, and that the seller is an authorized trading partner. TS is a compliance representation, not a data log. It answers "is the seller vouching for the legitimacy and authorization of this product," and it remains required today.

Comparison Table

Methods of Transmission

TI and TS may be transmitted in several forms:

• Paper — paper documents accompanying the shipment (the legacy form).
• Electronic / EDI — electronic data interchange, including standardized EDI transactions used widely by wholesalers.
• EPCIS — the Electronic Product Code Information Services GS1 standard, which captures package- and lot-level event data in a structured, interoperable format and which FDA recommends for the EDDS package-level regime.

How TI and TS Flow at Each Sale

When a wholesale distributor sells a covered product to a pharmacy, the distributor provides TI for that sale and TS attesting to the sale's legitimacy. When the pharmacy receives the product, it must be able to access and retain both documents for at least six years. If the pharmacy later transfers the product to another pharmacy, it in turn provides TI and TS unless the sale fills a specific patient need, which section 582(d)(1)(A)(ii) exempts.

What Replaced TH's Tracing Role

Under the EDDS regime — phased in by trading-partner type from May 27, 2025 through November 27, 2027 — the system moves from the old lot-level transaction-data approach to interoperable, electronic, package-level tracing. This is a separate, later-arriving layer from the TH sunset:

• TI and TS continue to flow at each transaction — nothing about EDDS removes them.
• TH's old tracing function — knowing the full chain of ownership back to the manufacturer — is now served by querying a package's history through its serialized product identifier, once EDDS applies to that trading partner, rather than by receiving a cumulative document with each sale.

Do not conflate the two dates: TH stopped being required on November 27, 2023 for every trading partner, regardless of that partner's own EDDS compliance date, which can run as late as November 27, 2027 for small dispensers.

Who Provides TI and TS, and When It Is Not Required

The obligation to provide transaction data runs with each sale of a covered product by an authorized trading partner. A manufacturer provides TI/TS when it sells to a repackager or wholesale distributor; a wholesale distributor provides TI/TS when it sells to a dispenser; a dispenser that transfers a covered product to another dispenser provides TI and TS unless the sale fills a specific patient need, which section 582(d)(1)(A)(ii) exempts. Transaction data is generally not required for transactions involving products that fall outside DSCSA's scope (the exclusions in Section 3.1) or for transactions that qualify for a specific DSCSA exemption (such as certain intracompany or affiliated-entity transfers and limited pharmacy-to-pharmacy transfers). The exam typically tests the general rule — covered product + sale by an authorized trading partner → provide TI and TS — rather than the narrow exemptions, so anchor on the general obligation first.

Worked Example

A pharmacy receives a shipment of a covered product from its wholesaler today. The wholesaler's paperwork includes TI (this sale's product, lot, date, quantity) and TS (the wholesaler's attestation) — it does not need to include a cumulative TH document, because that requirement sunset on November 27, 2023. Once EDDS applies to this wholesaler (August 27, 2025 for wholesale distributors), the pharmacy can also scan the package-level identifier and query the interoperable system for that package's history. Either way, TI and TS are what the pharmacy receives and retains.

Exam Tip

A common distractor presents TH as still required, or ties its removal to each trading partner's individual EDDS compliance date. Both are wrong. TH's sunset is a single, flat date — November 27, 2023 — set by section 582(k)(1), independent of the later, staggered EDDS package-level tracing dates. Today's rule is simply: TI + TS, not TH.