# DSCSA Section 582 Suspect Product Quarantine & Verification Rules
> Automate suspect and illegitimate prescription product quarantine checks, lot-level audits, and regulatory verification.

- **Canonical URL:** https://stanzaapi.com/tools/pharma-dscsa/compliance/suspect-product-verification
- **Governing Standard:** 21 U.S. Code § 360eee / GS1 EPCIS (U.S. Food & Drug Administration (FDA) DSCSA)
- **Latency:** <2ms Edge
- **Privacy:** In-memory execution only (zero data stored or logged)

## Technical Overview & Governing Rules
DSCSA requires trading partners to quarantine and investigate suspect products that are potentially counterfeit, diverted, stolen, contaminated, or subject to fraudulent transactions.

## Specification Matrix
| Step | Action | Timeframe | Regulatory Authority |
| --- | --- | --- | --- |
| Quarantine | Physically isolate and flag in electronic WMS/ERP | Immediate | 21 U.S.C. 360eee-1(h) |
| Investigation | Verify 4-element product identifier with manufacturer | Within 24 hours | DSCSA Section 582 |
| Notification | Submit FDA Form 3911 if determined illegitimate | Within 24 hours | FDA CDER |

## Standard JSON Response Model
```json
{
  "investigationId": "INV-2026-004",
  "productIdentifier": {
    "gtin": "00301234567896",
    "serial": "123456789012"
  },
  "quarantineStatus": "QUARANTINED",
  "auditRecommendation": "SUBMIT_FORM_3911"
}
```

## Frequently Asked Questions & Edge Cases
### Q: What triggers a DSCSA suspect product investigation?
**A:** Unverified serial numbers, mismatching lot/exp dates, packaging damage, or unconfirmed ownership transfer records in EPCIS.
