Drug Supply Chain Security Act Implementation and Readiness Efforts for 2023; Public Meeting; Request for Comments

Resumen

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled "Drug Supply Chain Security Act Implementation and Readiness Efforts for 2023" to allow supply chain stakeholders an opportunity to share their perspectives. The topics to be discussed are stakeholder experiences with implementation and overall readiness regarding implementation of enhanced drug distribution security requirements that will go into effect on November 27, 2023, standards for the interoperable data exchange of product tracing information, requests for product tracing information or verification from FDA for the purpose of investigating suspect or illegitimate products or for recalls, steps taken to build capacity for package-level tracing, pharmaceutical distribution supply chain best practices, and, in general, the impact that the Drug Supply Chain Security Act (DSCSA) requirements would have on public health, including patient safety and access to prescription drugs, and on stakeholders, in terms of costs, benefits, and regulatory burden.