DSC Logistics continues to be actively involved in healthcare regulatory issues as one of two 3PLs on the board of the Pharmaceutical Distribution Security Alliance (PDSA) and the Device Distribution Uniform Standards Alliance (DDUSA).
PDSA, a multi-stakeholder and interdisciplinary initiative, played a critical role in helping develop and advocate federal legislation that protects patient safety and ensures security of the drug supply chain, through a single national uniform product serializing and traceability system. PDSA is now working with congressional leaders and FDA regulators to clarify and implement this new system.
DDUSA, a coalition of many of the US’s largest manufacturers, distributors and third party logistics providers, is engaged in the legislative push for enacting a similar law for medical devices.
DSC’s Susan Winter, Manager, Regulatory & Compliance, met with other PDSA members and House Energy & Commerce Committee staff in Washington DC, Sept. 29, to communicate specific examples of licensing confusion, non-DSCSA compliant requirements and the resulting discrepancies to effective business practices across the US supply chain. Susan participated in this meeting as a subject matter expert (SME) in US prescription drug and device distribution licensing statutes, regulations and licensing.
Susan is working with other DDUSA Board members on establishing uniform national licensing standards for the distribution of medical devices in the US, tracking closely with DSCSA. Their goal is to have a major medical device distribution bill introduced and enacted as law in 2017.