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Rx-360 DSCSA Readiness Checklist for Distributors
Wholesale distributors play a pivotal role in safeguarding the integrity of the U.S. pharmaceutical supply chain under the Drug Supply Chain Security Act (DSCSA). The Rx‑360 DSCSA Readiness Checklist for Distributors distills core requirements into practical, actionable steps—including Authorized Trading Partner (ATP) verification, serialized EPCIS data exchange, product identifier verification, saleable returns management, suspect/illegitimate product procedures, electronic recordkeeping, and end‑to‑end interoperability. Use this checklist to assess your current state, close gaps, and ensure fast, reliable responses to audits and investigations.
When to Use This Checklist
- Implementation & system upgrades: As you deploy or enhance serialization, EPCIS connectivity, and verification workflows across receiving, warehousing, and shipping.
- Ahead of enforcement milestones: To confirm readiness for serialized data exchange, real‑time product identifier verification, and exception handling before key DSCSA deadlines.
- Partner onboarding and reviews: When adding or reassessing manufacturers and dispensers to validate ATP status and confirm GLN/EPCIS alignment.
- Internal audits & QA checks: To verify SOP completeness, training coverage, record retention, and the effectiveness of suspect/illegitimate product procedures.
How to Use the Checklist
- Work through each requirement area—ATP verification, serialized EPCIS data exchange, product identifier verification (GTIN, serial, lot, expiry), returns management, suspect/illegitimate product processes, electronic recordkeeping, and interoperability testing.
- Assess current state & document gaps by marking items as compliant, in progress, or pending; capture owners, timelines, and remediation tasks.
- Validate data integrity & connections by confirming GLN matching (where used), EPCIS message accuracy, and exception‑handling workflows for data mismatches.
- Operationalize saleable returns by linking returns to the original serialized transaction data and verifying serials in real time.
Reinforce SOPs and training so receiving, inventory control, customer service, and returns teams execute DSCSA‑compliant procedures consistently.
Retain and retrieve records—ensure your systems can store serialized transaction data for the required duration and retrieve it rapidly for audits/investigations.