DSCSA Delays Raise Doubts

Chain Drug Review

Christopher R. Smith, Senior Counsel, and John S. Linehan, Member of the Firm, in the Health Care & Life Sciences practice, co-authored an article in Chain Drug Review, titled “DSCSA Delays Raise Doubts.”

Following is an excerpt (see below to download the full version in PDF format):

Over the last six years, since the 2013 enactment of the Drug Supply Chain Security Act (DSCSA), late November has marked the introduction of new supply chain requirements for industry stakeholders, and this year the focus was on wholesalers. While some of the new provisions may present new burdens for wholesalers, the Food and Drug Administration has announced, as it has on numerous occasions in years past, a delay in enforcement for one statutory provision that will provide more latitude for wholesalers and manufacturers. Good or bad, the 2019 changes and enforcement delay will have significant consequences for the entire drug supply chain and the overall DSCSA implementation process.

The DSCSA is a federal law requiring tracking and tracing prescription drugs as they flow through the supply chain from manufacturers to dispensers. The law is designed to be phased in over a 10-year period, culminating in 2023, with the creation of an interoperable electronic data exchange to facilitate track-and-trace at the smallest saleable unit level. This year’s phased-in provisions are geared towards moving wholesalers closer to the 2023 goal line with important implementation deadlines governing product distribution, returns and verification. However, the changes present critical operational issues for stakeholders, and the FDA’s enforcement delays raise doubts about the overall implementation schedule.