November 27, 2018 marked five years since President Obama signed the Drug Quality and Security Act (DQSA) into law. The law addresses two distinct areas of drug oversight, but it was the combined concerns about the quality and reliability of the drug supply that enabled passage of the law:

• Title I, the Compounding Quality Act (CQA), primarily responded to an acute public health crisis that was caused by the distribution of contaminated steroidal injections, compounded without patient prescriptions, which had already claimed the lives of more than 60 Americans.

• Title II, the Drug Supply Chain Security Act (DSCSA), addressed the long-held desire for a federal drug tracking and tracing system to prevent a series of ills, especially the distribution of counterfeit drugs, but the particular timing was motivated by the pending onset of state-level drug-tracking requirements that the DSCSA ultimately preempted.