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.
