What does Title II of the Drug Quality and Safety Act of 2013 primarily address?

Title II of the Drug Quality and Safety Act of 2013 primarily addresses the systems for tracking and tracing prescription drugs as they move through the supply chain. This legislation was enacted as a response to concerns about drug safety and the integrity of the drug supply, particularly in light of incidences involving counterfeit drugs. The law established requirements for drug supply chain participants, including manufacturers, wholesalers, and pharmacies, to implement systems that can verify the legitimacy of drug products, maintain comprehensive records, and enable efficient identification of drugs that may be faulty or dangerous.

This tracking and tracing system is essential for ensuring that only safe and effective medications reach patients, thereby protecting public health. It creates a more transparent supply chain, facilitating recalls and mitigating the impact of drug shortages or adulteration incidents. While other elements related to drugs are indeed important, such as price and pharmacy licensure, they are not the focus of Title II, which specifically emphasizes the importance of drug tracking and tracing mechanisms.