Drug Quality and Security Act: Title II – Track and Trace System

The Drug Quality and Security Act (DQSA) was designed to clarify the Food And Drug Administration’s (FDA) oversight authority over drug compounding and update the federal drug tracking and tracing system.

Title II of the DQSA seeks to reduce drug shortages, theft, counterfeiting and drug diversion by modernizing existing federal law and replacing current state track and trace laws with a uniform national system for tracing drugs throughout the drug supply chain.

Title II:

1. Requires companies to use the unit-level interoperable tracing system, which is to be phased in over the next decade, to provide information about each drug to the next party in the supply chain;
2. Preempts state track and trace laws to help alleviate drug shortages and cut government-imposed prescription drug costs;
3. Recognizes third-party providers as part of the drug supply chain;
4. Creates licensure standards for wholesaler distributors and third-party providers, but preserves State authority for licensure issuance and fee collection; and
5. Requires the FDA to keep a public database that allows consumers and drug supply chain members to identify licensed wholesalers.