Unlimited Practice Guide · PTCE · ptce.md

DSCSA product tracing — the 3Ts

ptce/federal/dscsa-3ts · integrity: practice_only

Claim

Under the Drug Supply Chain Security Act, trading partners exchange transaction information, transaction history, and a transaction statement (the 3Ts) when ownership of a covered prescription product changes hands.

Plain

Think TI + TH + TS with every handoff of ownership. Dispensing to a patient is not that handoff. Federal floor; verify current FDA phase-in for your role.

Citations

  1. 21 U.S.C. § 360eee-1 (360eee-1(b)(1)(A)(i)) — source
    prior to, or at the time of, each transaction in which such manufacturer transfers ownership of a product, provide the subsequent owner with transaction history, transaction information, and a transaction statement
    retrieved 2026-09-07
  2. 21 U.S.C. § 360eee (360eee(25)–(27) definitions) — source
    Transaction history means a statement … including the transaction information for each prior transaction going back to the manufacturer of the product.
    retrieved 2026-09-07