Converge Perspective on the FDA Delayed Enforcement Originally published on the MassBio News & Thought Leadership blog On June 2, 2023, the Healthcare Distribution Alliance (HDA) submitted to the Federal Drug Administration (FDA) a letter outlining challenges for implementing the last mile of DSCSA compliance. Chief among these is manufacturers’ inability to [...]
DSCSA Implementation & Readiness Efforts for 2023 2023 is a crucial year for pharmaceutical trading partners as the Drug Supply Chain Security Act (DSCSA) deadline for full traceability approaches in November. To allow supply chain stakeholders an opportunity to share their perspectives, the FDA held a 2-day virtual public meeting. DSCSA Implementation [...]
Event Recap: 2022 & Beyond - Serialization Requirements for Manufacturers To ensure product safety, the Drug Supply Chain Security Act (DSCSA) requires pharmaceutical trading partners to share data that tracks product movement and traceability through the supply chain. The sharing of data is dependent on the Electronic Product Code Information System (EPCIS). Although [...]
An emerging specialty biopharmaceutical company was preparing for the U.S. launch of their first drug product. Building out their supply chain would involve implementing a serialization program to meet Drug Supply Chain Security Act (DSCSA) requirements. While Supply Chain team members had commercial launch experience, they were not as familiar with serialization. A successful [...]
Are You Ready for Serialization Implementation? A 7-Point Checklist for Emerging Pharma Companies Serialization implementation is probably on your radar already if you’re an executive at an emerging Biopharma company. Manufacturers need to implement a serialization management solution to fulfill today’s requirements under the Drug Supply Chain Security Act (DSCSA). So [...]
Life Sciences Supply Chain Working Group Webinar January 20, 2022 @ 12-1p ET 2022 & Beyond: Serialization Requirements for Manufacturers Read the Event Recap The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical trading partners to share data that tracks products and provides traceability through the supply chain. The sharing [...]
Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022 Originally published as a MassBio Guest Blog Stephanie L Byrne is a senior supply chain consultant and serialization lead focusing on DSCSA project leadership. She has helped more than a dozen life sciences companies realize the greatest impact from [...]
2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors Pharmaceutical manufacturers currently share transaction data with their trading partners at the lot level. The Drug Supply Chain Security Act (DSCSA) mandates package level traceability by November 2023. Cardinal Health and McKesson are requiring that manufacturers provide fully aggregated [...]
Manufacturers Need to Start Now to Prepare for 2022 Serialization Requirements While the Drug Supply Chain Security Act (DSCSA) does not require manufacturers to send package-level serialization data downstream until November 27, 2023, the Big 3 distributors are accelerating this timeline and requiring that data by November 2022. Cardinal Health and McKesson [...]