10.1 DSCSA Track-and-Trace Requirements: Transaction Information, History & Statements (3 T's)

10.1 DSCSA Track-and-Trace Requirements: Transaction Information, History & Statements (3 T's)

MPJE Core Concept: Title II of the Drug Quality and Security Act (DQSA) of 2013, known as the Drug Supply Chain Security Act (DSCSA), establishes a national, electronic, interoperable system to trace human prescription drugs at the package level as they move through commercial distribution. Pharmacists must understand trading partner qualifications, mandatory product tracing documentation (the 3 T's), record retention rules, and exempt transactions.

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Legislative Overview and Objectives

Prior to the enactment of the DSCSA in November 2013, state laws governed drug pedigree requirements, resulting in a fragmented patchwork of state regulations and paper-based tracing. The DSCSA created a uniform federal framework to protect consumers from drugs that are counterfeit, stolen, contaminated, adulterated, or otherwise dangerous.

The law establishes a ten-year phased implementation model culminating in full, electronic, interoperable package-level product tracing among all commercial trading partners.

Primary Goals of the DSCSA

1. Standardized Tracing: Implement electronic product tracing across manufacturers, repackagers, wholesale distributors, third-party logistics providers (3PLs), and dispensers.
2. Product Identification: Require unique 2D Data Matrix barcodes containing standardized numeric identifiers (SNIs) on all individual prescription packages.
3. Verification & Quarantine: Mandate protocols to quarantine, investigate, and notify regulatory authorities regarding suspect or illegitimate products.
4. Trading Partner Verification: Restrict all commercial drug transactions exclusively to Authorized Trading Partners (ATPs).

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Authorized Trading Partners (ATPs)

Under the DSCSA, a dispenser (pharmacy) may only accept ownership of prescription drugs from an Authorized Trading Partner. Operating with an unlicensed or unregistered entity constitutes a federal violation.

Key Exam Tip: A pharmacy must verify that its wholesale distributors and manufacturers are validly licensed ATPs prior to purchasing prescription drug inventory.

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Product Identifier & Standardization

The DSCSA mandates that manufacturers and repackagers affix a 2D Data Matrix barcode containing four critical data elements (the Product Identifier) on each individual package and homogenous case of prescription drug:

1. National Drug Code (NDC): Standard 10- or 11-digit identifier.
2. Unique Serial Number: An alphanumeric string up to 20 characters assigned to that specific individual package.
3. Lot Number: Manufacturer batch/lot code.
4. Expiration Date: Format set by federal standards.

These elements must appear in both machine-readable format (2D Data Matrix barcode) and human-readable format on the package label.

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The 3 T's: Required Product Tracing Documentation

When ownership of a prescription drug is transferred within the supply chain, the seller must provide the buyer with three specific pieces of product tracing documentation, collectively known as the 3 T's:

1. Transaction Information (TI)

Transaction Information includes the explicit physical and commercial details of the drug product involved in the transfer:

• Name of the drug product
• Strength and dosage form of the product
• National Drug Code (NDC)
• Container size and number of containers
• Lot number of the product
• Date of the transaction
• Date of shipment (if different from transaction date)
• Business name and address of the entity transferring ownership (seller)
• Business name and address of the entity receiving ownership (buyer)

2. Transaction History (TH)

Transaction History is an electronic statement accounting for the cumulative sequence of prior transactions for the product, back to the original manufacturer. It details each prior transfer of ownership, including dates and business names/addresses of all intermediate trading partners.

(Note: Under full 2023+ DSCSA interoperable electronic implementation, TH is generated dynamically from secure electronic databases rather than passed as a static paper document).

3. Transaction Statement (TS)

Transaction Statement is a formal statement (electronic or written) submitted by the entity transferring ownership, attesting that the entity:

• Is an Authorized Trading Partner under the DSCSA.
• Received the product from an Authorized Trading Partner.
• Received Transaction Information and Transaction Statement from the seller (if applicable).
• Did not knowingly ship a suspect or illegitimate product.
• Has fulfilled all statutory verification requirements under Section 582 of the FD&C Act.
• Did not knowingly alter the product history or falsify information.

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6-Year Record Retention Requirement

All trading partners in the supply chain—including community, health-system, and specialty pharmacies—must retain all TI, TH, and TS documentation for a minimum of six (6) years from the date of the transaction.

+-----------------------------------------------------------------------------+
|                      DSCSA 6-YEAR RECORD RETENTION RULE                      |
|                                                                             |
|  All Transaction Information (TI), Transaction History (TH), and            |
|  Transaction Statements (TS) MUST be retained for at least 6 YEARS          |
|  from the date of transaction.                                              |
|                                                                             |
|  * Must be retrievable upon request during FDA or State Board inspections.   |
|  * Electronic storage is standard and acceptable if securely backed up.     |
+-----------------------------------------------------------------------------+

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Exempt Transactions from 3 T's Tracing

Not every transfer of a prescription drug requires the exchange of 3 T's documentation. Congress established specific statutory exemptions tailored to routine patient care and emergency situations.

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Comparative Summary: The 3 T's at a Glance