FDA to Hold Virtual Meeting on DSCSA Implementation
FDA will hold a virtual public meeting Dec. 7-8 on implementation of the Drug Supply Chain Security Act and readiness for requirements that will take effect in 2023, it said in a notice released Nov. 4. Topics to be discussed…
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include “stakeholder experiences with implementation and overall readiness regarding implementation of enhanced drug distribution security requirements” that take effect Nov. 27, 2023, as well as “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 [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.”