The Pharmaceutical Distribution Security Alliance (PDSA) is a multi-stakeholder and interdisciplinary initiative committed to safeguarding patients by ensuring the chain remains as secure as possible.
PDSA played a critical role in helping develop and enact federal legislation that protects patient safety and ensures security of the drug supply chain, through a single national uniform system for product serialization and traceability. PDSA now works with the Food and Drug Administration (FDA) and Congressional stakeholders to clarify and implement this new system, as enacted by the federal Drug Supply Chain Security Act (DSCSA), and to address other issues of importance to the pharmaceutical distribution supply chain.
PDSA has three main objectives:
- Understanding the DSCSA to identify ambiguities and challenges in the law that require clarification or the development of operational solutions.
- Engaging the FDA to ensure regulation is consistent with PDSA objectives and the best reading of DSCSA.
- Working with members to identify, develop, and memorialize the cross-sector challenges and needs to move the industry toward unit-level interoperability by 2023.
The members of PDSA span the entire spectrum of the U.S. pharmaceutical distribution system. More than 30 companies and trade associations are formal members of PDSA and many other external stakeholders provide additional policy and technical support to the group.
Our members include:
- Biologic and Pharmaceutical Manufacturers, both brand and generic: We develop and manufacture therapies and treatments for a multitude of diseases and disorders;
- Wholesale Distributors, both primary and secondary: We procure products from manufacturers and sell them to multiple sources including hospitals, long-term care facilities, and pharmacies;
- Pharmacies, both chain and independent: We dispense life-saving and life-enhancing medications to patients; and
- Third-Party Logistics Providers (3PLs): We provide valuable supply chain management services on behalf of healthcare clients.