The Drug Supply Chain Security Act (DSCSA), enacted on November 27, 2013 aims to help combat the threat of pharmaceutical diversion by enhancing the traceability of prescription pharmaceutical products in the U.S. This letter communicates trading partners’ DSCSA implementation plan using LSPediA as their DSCSA solution provider for EPCIS and VRS.
The US FDA published a compliance policy final guidance document on September 23, 2019, announcing a one-year enforcement discretion for the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product. But before you breathe a sigh of relief, you need to read the entire guidance document and the entirety of this LSPediA article.
LSPediA partnered with the FDA in order to conduct a pilot that tracks end-to-end supply chain transactions utilizing the product identifier, specifically the 2D data matrix barcode, for drug product verification and tracing.
The DSCSA requirement for manufacturers is now more important than ever. With an ever-evolving timeline, the enforcement dates from the FDA aren’t always clear. LSPediA breaks down exactly what manufacturers are required to do to be compliant and when those regulations are enforced.
The Drug Supply Chain Security Act (DSCSA) sets out multiple phases of compliance that started Nov. 27, 2013 and finish rolling out Nov. 27, 2023. This includes Serialization and Product Tracing. Understanding the DSCSA Requirement for Dispensers is vital in today’s market.