Assessing Current Implementation of DSCSA Serialization Requirements
Pharmaceutical distributors take snapshot of where manufacturers stand on Phase 2
On November 27, 2017, pharmaceutical manufacturers faced an important deadline: compliance with Phase 2 of the 2013 Drug Supply Chain Security Act (DSCSA). Although the FDA recently issued guidance* indicating that it will delay enforcement of those requirements until November 2018, the implementation deadline remains in effect.
While Phase 1 focused on the exchange of lot-level chain-of-ownership data among all supply chain partners, Phase 2 focuses on item-level serialization. Pharmaceutical products must be marked with a National Drug Code (NDC), Serial Number, Lot Number, and Expiration Date in both machine-readable and human-readable format.**
To assess where the industry stands on Phase 2 implementation, AmerisourceBergen (ABC) and McKesson Pharmaceutical (McKesson)—in collaboration with GS1 Healthcare US® — each conducted DSCSA barcode assessments in May 2017. This paper presents their findings to offer a snapshot of implementation progress.
* Source: FDA Draft Guidance: Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. June 30, 2017.
** Source: 2013 Drug Supply Chain Security Act.