GDP in the US: FDA publishes YouTube Video on DSCSA Implementation
Register now for ECA's GMP Newsletter
The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research (CDER) has provided a webinar on the Drug Supply Chain Security Act (DSCSA) implementation.
According to the agency, during the webinar entitled "Implementing DSCSA: Stabilization Period and Expectations" the following topics are covered:
- "DSCSA implementation and expectations for trading partners to achieve interoperable, electronic tracing of products at the package level
- Recent guidance documents for industry related to supply chain security requirements
- The stabilization period from November 27, 2023, to November 27, 2024, which allows trading partners additional time to implement, troubleshoot, and mature their systems and processes while supporting the continued availability of products to patients"
The FDA writes that the intended audience includes trading partners (manufacturers, repackagers, wholesale distributors, dispenser) obligated to adhere to the DSCSA enhanced drug distribution security requirements, other stakeholders that may work with trading partners to develop systems and process for the DSCSA requirements and state regulators.
The video is available on the FDA website or can be viewed directly on YouTube.
Related GMP News
16.01.2025EMA adds Considerations for Wholesale Distributors and Brokers on suspicious Offers
16.01.2025Swissmed informs about Control Campaign against illegal Trading in Medicinal Products
16.01.2025Two new PICS Documents on Remote Assessments published
16.01.2025The GDP Non-Compliance Reports of 2024 - An Overview
17.12.2024GDP in the US: Pre-posting of USP Chapter <1079.2> on MKT
17.12.2024Romanian Authority Issues further GDP Non-Compliance Report