PDSA Questions & Answers on DSCSA 2023 Requirements
These questions and answers have been prepared by the Pharmaceutical Distribution Security Alliance (PDSA), a multi-stakeholder coalition with membership that spans the entire spectrum of the U.S. pharmaceutical distribution system, including manufacturers, wholesale distributors, third-party logistics providers, and pharmacies. This document includes a number of operational questions that have been identified by PDSA with regard to the provisions of the Drug Supply Chain Security Act (DSCSA) that take effect November 27, 2023. The answers provided in this document reflect PDSA’s understanding of the DSCSA and are being provided to the FDA for its consideration. Where appropriate, we ask that FDA clarify its position on these issues through guidance documents, regulations or its preambles, or other proper means.