Key Implementation Challenges in the Supply Chain Security Provisions of the DQSA
Source: The Food and Drug Law Institute
For at least the past decade, federal and state regulators have been concerned about potential threats to supply chain security and patient safety, which may arise from gaps in the pharmaceutical supply chain. The threats have been reassuringly few in number and limited in severity, the risk to patients, to stakeholder brands, and even national security. Nevertheless, more focused attention from regulatory and legislative bodies was justified with each new threat to supply chain integrity.