Pharmaceutical manufacturers and their trading partners should ensure their distribution systems fully adhere to the Drug Supply Chain Security Act (DSCSA), as once the law takes full effect this November, the US Food and Drug Administration (FDA) will begin inspecting firms to verify their compliance, asserted Howard Sklamberg, a partner at Arnold & Porter.
He outlined what FDA will be looking for in inspections at a 22 February webinar sponsored by the Food and Drug Law Institute (FDLI). Sklamberg was the director of FDA’s Office of Compliance in 2013, when DSCSA was enacted.
Sklamberg and a panel of legal experts spoke about the compliance and enforcement considerations in preparing for DSCSA.
He observed that while FDA has been slow to enforce DSCSA due to the law’s gradual phase in of requirements, this is expected to change once the interoperability requirements take effect on 27 November 2023. On this date, manufacturers are expected to use an interoperable data exchange to track products through the supply chain…
