INSIGHT: The Drug Supply Chain Security Act and Preemption of State Laws

Bloomberg Law

Christopher R. Smith, Senior Counsel in the Health Care & Life Sciences and Litigation & Business Disputes practices, in the firm’s Washington, DC, office, authored an article in Bloomberg Law, titled “INSIGHT: The Drug Supply Chain Security Act and Preemption of State Laws.”

Following is an excerpt:

In the less than six years since the federal Drug Supply Chain Security Act was enacted, the issue of the scope of the act’s preemption of state laws has arisen multiple times in various contexts.

Industry, the states, and the federal government are still trying to figure out the DSCSA preemption issue, and therefore, those who are regulated by the act should continue to pay close attention.

Congress enacted the DSCSA in 2013. The act was crafted in response to the danger to patient safety of counterfeit drugs entering the U.S. prescription drug supply chain. Congress designed the law to require drug supply chain stakeholders to trace prescription drugs, in a secure manner, from the manufacturer down to the dispenser of the drug.

When fully implemented, the law will require drug supply chain stakeholders to securely exchange transactional data regarding prescription drugs through an electronic interoperable data exchange.

The law also imposes requirements on stakeholders to investigate suspect prescription drugs within the supply chain and remove illegitimate prescription drugs from the system. Finally, the DSCSA establishes national licensure and licensing standards for drug wholesalers and third-party logistics providers.