DSCSA Section 582 Suspect Product Quarantine & Verification Rules
Automate suspect and illegitimate prescription product quarantine checks, lot-level audits, and regulatory verification.
Quick Technical Summary: Automate suspect and illegitimate prescription product quarantine checks, lot-level audits, and regulatory verification. Implementation conforms to 21 U.S. Code § 360eee / GS1 EPCIS.
Specification & Structural Breakdown
DSCSA requires trading partners to quarantine and investigate suspect products that are potentially counterfeit, diverted, stolen, contaminated, or subject to fraudulent transactions.
| 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 |
Test DSCSA Section 582 Suspect Product Quarantine & Verification Rules Live
Paste raw inputs up to 32KB and inspect deterministic parsed JSON in real-time across 330+ Cloudflare edge locations. Pure compute, zero cold-starts.
Parsed JSON Response Model
The edge microservice transforms input payloads into strongly-typed hierarchical JSON with zero cold starts:
{
"investigationId": "INV-2026-004",
"productIdentifier": {
"gtin": "00301234567896",
"serial": "123456789012"
},
"quarantineStatus": "QUARANTINED",
"auditRecommendation": "SUBMIT_FORM_3911"
}
Copy-Paste Integration Code
Integrate this validator directly into your application using your production API key:
curl --request POST \
--url "https://fda-dscsa-eu-fmd-drug-serialization-api-21-usc-360eee.stanzaapi.com/api/v1/dscsa/validate-barcode" \
--header "Content-Type: application/json" \
--header "x-api-key: YOUR_API_KEY" \
--data '{
"rawBarcode": "010030123456789621123456789012\u001d1726083110LOT99881"
}'
const response = await fetch("https://fda-dscsa-eu-fmd-drug-serialization-api-21-usc-360eee.stanzaapi.com/api/v1/dscsa/validate-barcode", {
method: "POST",
headers: {
"Content-Type": "application/json",
"x-api-key": process.env.API_KEY || "YOUR_API_KEY"
},
body: JSON.stringify({
"rawBarcode": "010030123456789621123456789012\u001d1726083110LOT99881"
})
});
const data = await response.json();
console.log(data);
import requests
import json
url = "https://fda-dscsa-eu-fmd-drug-serialization-api-21-usc-360eee.stanzaapi.com/api/v1/dscsa/validate-barcode"
headers = {
"Content-Type": "application/json",
"x-api-key": "YOUR_API_KEY"
}
payload = {
"rawBarcode": "010030123456789621123456789012\u001d1726083110LOT99881"
}
response = requests.post(url, json=payload, headers=headers)
print(response.json())
package main
import (
"bytes"
"fmt"
"io"
"net/http"
"os"
)
func main() {
url := "https://fda-dscsa-eu-fmd-drug-serialization-api-21-usc-360eee.stanzaapi.com/api/v1/dscsa/validate-barcode"
payload := []byte(`{"rawBarcode":"010030123456789621123456789012\u001d1726083110LOT99881"}`)
req, _ := http.NewRequest("POST", url, bytes.NewBuffer(payload))
req.Header.Add("Content-Type", "application/json")
req.Header.Add("x-api-key", os.Getenv("API_KEY"))
res, err := http.DefaultClient.Do(req)
if err != nil {
panic(err)
}
defer res.Body.Close()
body, _ := io.ReadAll(res.Body)
fmt.Println(string(body))
}
Frequently Asked Questions & Technical Notes
Unverified serial numbers, mismatching lot/exp dates, packaging damage, or unconfirmed ownership transfer records in EPCIS.
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