Drug Supply Chain Security Act (Title II of Drug Quality and Security Act 2013) 10-year framework for interoperable electronic package-level prescription drug traceability. Standardized Numerical Identifier per saleable package — GS1 Serialised GTIN (sGTIN-14 plus unique serial) as 2D DataMatrix with lot and expiration. Aggregation links unit-case-pallet via SSCC for inference at receiving. EPCIS 1.2 events — Object Event (commissioning, decommissioning, shipping, receiving), Aggregation Event (parent-child), Transaction Event (linking objects to business transactions), Transformation Event (repackaging) — each with event time, action ADD/OBSERVE/DELETE, business step, disposition, EPC list, business transaction list, source/destination master data. Location Master Data (GLN) and Product Master Data (GTIN, NDC) cross-partner alignment is the dominant data-quality issue. Transaction-level data — Transaction Information (TI), Transaction History (TH), Transaction Statement (TS). Verification Router Service for saleable-returns — wholesaler queries with GTIN/serial/lot/expiration, VRS routes to manufacturer verification system, response within 2-30 seconds. Authorised Trading Partner — manufacturers (FDA registered), repackagers, wholesale distributors (state license + NABP Drug Distributor Accreditation), dispensers (state pharmacy license); verification at onboarding and material change. Suspect product framework (Section 582) — quarantine and investigate within 24-72 hours, if illegitimate notify FDA via Form FDA 3911 within 24 hours and notify immediate trading partners. Original effective date November 27, 2023; FDA stabilization compliance policy August 2023 extended enforcement to November 27, 2024 for manufacturers/repackagers/wholesalers/dispensers; further extension to November 27, 2025 for non-small dispensers and November 27, 2026 for small dispensers (≤25 FTE). 503A compounding generally exempt; 503B outsourcing partially exempt. Veterinary drugs not subject. Industry guidance includes GS1 US Healthcare DSCSA EPCIS Implementation Guideline and HDA reference architecture.

Regulatory anchors

Drug Quality and Security Act 2013 Title II
21 USC §360eee
FDA Compliance Policy August 2023
FDA Compliance Policy October 2024

Industries that live with this

Pharmaceutical Vet Pharma Radiopharma

How V5 handles it

Lot traceability — recall in minutes, not weeks.

V5 captures the lot link at every point of consumption, so the trace is a query — not a war room.

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

Supplier portal — chase nothing. Score everything.

Suppliers log in, see what you need, submit it against your spec, and watch their scorecard. SCARs are raised, replied to and closed in the portal — not in your inbox.

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

Related terms

FSMA 204 21 CFR Part 11