DSCSA Track-and-Trace — End-to-End Pharmaceutical Traceability

What Is DSCSA Track-and-Trace?

DSCSA track-and-trace refers to the end-to-end electronic system for tracking prescription drugs from manufacturer to dispenser at the individual package level. Unlike older lot-level systems, DSCSA requires tracking at the unit level — meaning every individual package has a unique serial number.

DSCSA Enforcement Timeline for Interoperability

The interoperability requirement — that trading partners must electronically exchange and verify product information — was established with a statutory deadline of November 27, 2023. FDA then granted a one-year stabilization period to allow the industry to build out the necessary electronic infrastructure, followed by phased enforcement:

• November 27, 2024 — end of stabilization period; FDA issued phased exemptions
• May 27, 2025 — manufacturers and repackagers: full enforcement in effect
• August 27, 2025 — wholesale distributors: full enforcement in effect
• November 27, 2025 — dispensers with 26 or more full-time pharmacy employees: full enforcement in effect
• November 27, 2027 — extended deadline for small dispensers (25 or fewer full-time pharmacy employees); FDA extended the exemption on August 7, 2026

Electronic systems must now be able to:

• Transmit product identifiers in a standardized format (GS1 standards are the industry default)
• Query manufacturer verification routers to confirm a product identifier is authentic
• Receive and process Verification Router Service (VRS) responses in real time

How the Verification Router Service Works

When a trading partner needs to verify a product, the request flows through a Verification Router Service (VRS):

1. The pharmacy or distributor scans the 2D barcode on a package
2. The scan data is sent to a VRS (such as the one operated by NABP or RxTrail)
3. The VRS routes the request to the manufacturer's verification system
4. The manufacturer confirms or denies the product identifier
5. The result is returned to the requestor — typically within seconds

If a product fails verification, the trading partner must quarantine it and investigate. If investigation confirms the product is suspect or illegitimate, they must notify the FDA and their state board of pharmacy.

EPCIS for Downstream Traceability

Many wholesale distributors (including Premier Pharma) also support GS1 EPCIS (Electronic Product Code Information Services) for sharing serialization event data with downstream trading partners. EPCIS events include:

• Shipping events — when and where a product was shipped
• Receiving events — when and where a product was received
• Aggregation events — how individual packages are grouped into cases and pallets

EPCIS data is typically transmitted as XML or JSON documents via EDI or API.

What Your Pharmacy Needs to Do

At minimum, your pharmacy must:

1. Accept only serialized product from authorized distributors
2. Be able to verify product identifiers on request (either through a VRS or through your distributor)
3. Quarantine and investigate any product that fails verification
4. Retain T2 records (TI + TS) for 6 years
5. Notify FDA and state regulators if you identify suspect or illegitimate product

Premier Pharma provides all necessary serialization data, T2 documentation (TI + TS), and EPCIS event records with every shipment. Our ScriptTrack software helps automate verification workflows for high-volume dispensers.