US FDA: Pharmaceutical Distribution Entering DSCSA Compliance ‘Stabilization Period’

09 Sep 2023

Agency officials advise drug supply chain partners what stabilization activities they expect to see during one-year “enforcement discretion” period; industry lawyers advise that anyone found coasting could face discretionary enforcement. More discretion, more guidance in the works, including a final ruling on state preemption.

Pharmaceutical manufacturing in the abstract — time to smooth out package-level tracing • Source: Shutterstock

Pharmaceutical distribution trading partners should view the year of enforcement discretion the US Food and Drug Administration recently granted them for package-level Drug Supply Chain Security Act requirements as a “stabilization period” rather than a deferral, US FDA officials told a packed house at a recent industry stakeholder gathering.

The one-year delay in enforcing requirements that take effect 27 November will give manufacturers, wholesale distributors and dispensers time to...