DSCSA Compliance with Prodigy 360

In today’s pharmaceutical landscape, ensuring the safety, authenticity, and reliability of drug products is paramount. The Drug Supply Chain Security Act (DSCSA) sets the standard for maintaining the integrity of the pharmaceutical distribution chain from manufacturer to pharmacy. As a dispenser with >= 26 full-time employees, choosing a DSCSA compliant distributor by November 27, 2025 is not just about meeting regulatory requirements; it’s about safeguarding public health and enhancing operational efficiency. For those smaller dispensers with less than 26 employees, you will have until November 27, 2026.

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Do You Know the DSCSA Requirements?

There is a significant amount to catch up on if you're new to the upcoming mandates. To help accelerate your awareness, below are 10 requirements your business will need to address:

Supplier Validation - Ensure all product suppliers are verified and validated by dispensers to maintain a trustworthy supply chain.

Data Storage: Collect, verify, and store historical and current ASN (Advance Shipment Notice) and EPCIS (Electronic Product Code Information Services) data to maintain accurate records.

Illegitimate Drug Quarantine: Isolate and quarantine drugs suspected of being illegitimate, following FDA guidelines to prevent distribution.

Suspect Drug Notification: Report any suspected illegitimate drugs to the FDA and trading partners using the tracked Form 3911 for transparency and action.

Timely Response: Improve response times to government authorities and trading partners from 48 hours to 24 hours, ensuring prompt action on issues.

Serialization Data Validation: Validate serialization data to ensure that dispensers only buy and sell products encoded with unique product identifiers (PIs).

Lot Number Validation: Verify each product at the package level by checking the lot number and the serialized numerical identifier (SNI) to ensure authenticity.

System Integration: Integrate ASN and EPCIS data across internal operating systems within each ATP (Authorized Trading Partner) for seamless data flow and accuracy.

Interoperability: Ensure secure data exchange between ATPs for DSCSA (Drug Supply Chain Security Act) compliance, allowing for smooth and secure interoperability.

Regulation Communication: Communicate regulations and establish detailed reporting of Enhanced Drug Distribution Security (EDDS) with interoperable electronic tracing of products, catering to onsite and remote inspection requirements.

DSCSA Compliance with Prodigy 360

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